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Monthly Archives: March 2021
How the next generation of automation will drive warehouses of the future – Business Insider
Posted: March 31, 2021 at 6:37 am
COVID-19 has upended many businesses, but none more so than brick and mortar stores that rely on foot traffic. The combination of government-mandated shutdowns and consumer worry made these retailers' sales tank in 2020, with almost 10,000 U.S. stores closing permanently. But consumers didn't stop shopping trapped at home, they took their buying online, which led to an e-commerce boom.
That boom has strained distribution and fulfillment centers, which every online order passes through before reaching a buyer's doorstep. The pandemic exacerbated existing labor shortages in these warehouses; meanwhile, consumers expect online orders to arrive faster than ever, with two-day shipping the new standard. Warehouses are under tremendous pressure to do more with less.
These challenges won't go away when the pandemic ends. In fact, IBM research shows that COVID accelerated the shift to e-commerce by 5 years. To keep up with this growth in e-commerce and to compete against the likes of Amazon, companies have begun viewing automation as more than a competitive advantage it's now a necessity. Warehouses must embrace new automation technologies like robotics and connected devices. Existing automation has already improved safety and efficiency, and warehouses that embrace the next generation flexible solutions for monitoring and changing workflows on demand will flourish. Here's how automation has already addressed some of the biggest warehouse challenges and what's next.
The world has changed drastically in the last half century, but some warehouses haven't. Many remain labor intensive, relying on workers to find a specific item in a sea of products and walk with it, sometimes miles, to the right processing station.
As the pandemic increased demands on warehouses, many companies struggled to hire staff to keep up while following COVID-19 regulations. Facing growing order volumes, these companies had to rely on staff to walk miles every day to pick products off shelves and keep operations running.
Among warehouses that have embraced automation, the pandemic proved all automation is not created equally. Many warehouses that have automation in place rely on fixed solutions such as conveyors and sortation systems, which can take 6-9 months to implement and are difficult to adjust to support new workflow needs. These fixed solutions were pushed to their limit in 2020, as facilities sought to meet new demands and make changes to their workflows on the fly.
In response, some companies have begun automating specific workflows within their warehouses to reduce pressure on workers and increase productivity. COVID-19 accelerated this trend as facilities had to adopt social distancing rules and limit the number of workers in their facilities. In some of these facilities, employees now work side-by-side with mobile robots that quickly move goods across long distances, reducing physical strain on workers and speeding up production.
Automation also makes it easier for companies to operate warehouses in smaller facilities. As retail foot traffic dried up and online demand soared, some companies outfitted old retail stores that are closer to population centers as distribution centers. Using robots to power operations at all hours, they can fulfill and deliver orders faster.
Historically, a major sticking point in automation adoption is the time and cost of installation. Installing fixed automation systems requires facilities to cut operations in half for weeks. That obstacle is fading: new flexible automation solutions can be operational in a day. For example, warehouse workers can unbox a mobile robot, connect it to wifi and have it autonomously moving materials within hours.
In the case where there is a large investment in fixed automation that companies want to leverage, but still implement flexible automation like AMRs, cloud-based AMRs offer a way to bridge the gap between these two types of automation. For example, AMRs can autonomously move totes on and off a conveyor system by moving to the end of the conveyor, letting the cloud software know that it is next to the conveyor, and have the cloud software turn on the conveyor system and the rollers on top of the AMR to move a tote on or off the AMR. The same sort of integration can be used with other types of fixed automation.
Even after automation is installed, another challenge is that warehouse work effectively happens in a black box. Facility managers see what goes in and out, but not which aisles are congested or when a forklift moves too fast. Mobile robots with sensors can help by acting as "hall monitors," showing managers the floor in real-time. Managers can spot inefficiencies and dangers, then create strategies to increase productivity and stop accidents before they happen.
As the shift from physical stores to e-commerce continues, warehouses will be more essential than ever to companies' relationships with their customers and their bottom lines. With an ongoing labor shortage and heightened consumer demand, warehouses that embrace a new generation of flexible automation will be safer and more efficient.
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Automation Workz Now Offering Diversity Culture Audits to Increase Black Consulting Business Contracts – PRNewswire
Posted: at 6:37 am
DETROIT, March 30, 2021 /PRNewswire/ --Many companies pledged to increase their diversity after the death of George Floyd, a Black man at the hands of a white police officer, roiled the nation. Thus far, however, the pledges have not resulted in more contracts with Black consulting businesses, says Ida Byrd-Hill, CEO of Automation Workz, a cybersecurity reskilling and diversity consulting firm.
The report, "Why Are Black Employers More Likely than White Employers to Hire Blacks?" written by Stoll, Raphael, and Holzer, shows a large percentage of Black consulting businesses hire Black people. Black women have suffered the greatest job losses of any minority population during the pandemic even as Black consulting businesses are not getting their share of business contracts, to continue their employment, Byrd-Hill says.
This is true even in the automotive supply chain which has supplier diversity departments to assist Black businesses in acquiring contracts. Still, those departments are not responsible for consulting contracts in media, marketing, HR, training, meeting planning, finance, real estate and technology. Often, those contracts and bids are not publicly disseminated, Byrd-Hill says.
"As the CEO of a certified minority supplier, Automation Workz, that provides Diversity Culture Audits to break down the discriminatory walls of business, I believe American, Japanese and Korean automotive companies need a Diversity Culture Audit to determine why Black consulting businesses are not acquiring 14% of contracts from them, especially since African Americans buy a lot of cars," Byrd-Hill says.
Diversity is not just a social justice issue; it is an economic imperative to seize $9 trillion in diverse populations' spending power. Diverse consulting suppliers and employees are ambassadors to seize this spending power. "A Diversity Culture Audit documents the mindset of executives, reviews the operations of multiple departments then coaches them to create plans to acquire more diverse market share," she says. When the Diversity Culture Audit is completed and a strong executive coach regiment is installed, the process of increasing revenue with diversity, flourishes, Byrd-Hill says.
Attention meeting planners: Ida Byrd-Hill, CEO, Automation Workz, is available to turn this serious discussion into a lighthearted speech for your next executive meeting.
Watch a video of Diversity Culture Audit concepthere.
About Ida Byrd-HillIda Byrd-Hill is an economist, futurist, educator and author ofInvisible Talent Market. She holds an MBA from the Jack Welch Management Institute at Strayer University, with a specialization in people management and strategy. Byrd-Hill has appeared on Good Morning America, numerous radio stations and podcasts.
Contact: Ida Byrd-Hill, (313) 483-2126;[emailprotected];http://www.autoworkz.org/
SOURCE Ida Byrd-Hill
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The Most Recent Developments in Automated 3D Printing – AZoM
Posted: at 6:37 am
Image Credit:FabrikaSimf/Shutterstock.com
Individually, automation and 3D printing are powerful tools, but when combined can achieve groundbreaking results. In one recently debuted initiative, researchers have created an automated manufacturing line that is capable of 3D printing custom low-cost prosthetic limbs. In another development, mostly automated 3D printing is slated to fabricate an entire neighborhood of homes in California that are designed and priced for the middle class.
The cost of a prosthetic can run anywhere from $3,000 to $100,000. Because of this, quite a few amputees are unable to access these crucial medical devices, which must be customized to individual patients. Custom prosthetics usually call for a costly manual fitting from skilled professionals to attain ideal results.
In a newly debuted process from scientists at the Israeli Institute of Technology, an amputee's unaffected extremity can be scanned, customized using CAD software, and used to print a replacement device. The system produces life-like prosthetics with advanced gripping capabilities, in the case of upper limbs.
In addition to being cost-prohibitive, prosthetics come with several other issues that result in high rates of rejection, including their look, weight, gripping force, and absence of sensory feedback. Patient rejection can have serious physical consequences, including skeletomuscular degeneration, uncomfortable inflammation, and a multitude of other possibly acute difficulties.
Additive manufacturing, or 3D printing, processes have made it possible to decrease the number of steps needed to build prosthetics while opening possibilities for more complex designs. The new Israeli system leverages a digital design pipeline to churn out affordable devices with minimal human intervention.
The new production line comprises four fundamental stages: scanning, design, fabrication, and assembly. For the scanning phase, the team developed a low-cost custom scanner for approximately $40.
Throughout the design phases, the appearance of the device could be tailored to suit personal preferences. Patients can choose between body-powered and more sophisticated control mechanisms. Once a final design has been approved, an STL file is sent for printing.
Even though the scientists process still calls for various parts to be manually assembled, the Israeli team said its system could still be optimized to accelerate the process, making fabrication straightforward, fast, and accessible.
The prosthetics produced by the system are capable of holding common items and pouring liquids for more than 50,000 repetitions. In other exams, the prosthetics showed the capability to adjust their degree of grip to both soft and hard objects, with on-board motors halting at different times based on degrees of resistance. Importantly, when devices made by the system were shown to amputees, the reviews were positive, suggesting patients may not reject them based on appearance.
The team said its automated 3D printing production line could drastically decrease the cost of prosthetics for those who need them.
A construction technology business is expected to yield the first 3D-printed neighborhood in California, United States.
Inside a large Oakland, California warehouse, Mighty Buildings fabricates homes using 3D printers the size of compact garages. With as much as 80% of the process being automated, according to the company, construction requires 95% fewer labor hours. It also uses 10 times less waste than standard construction methods.
Video Credit:Mighty Buildings/YouTube.com
Mighty Buildings has said it can create housing units in the span of two to three weeks, at a price thats approximately 40% of similar-quality builds and with nearly zero waste. Walls are fabricated using a gantry-supported 3D printer with a total range of motion.
The system applies thermoset composite layers that harden into a masonry-type material, which is comparable in durability to concrete, but lightweight, self-supporting, and insulating. After fabrication is completed, a 3D scanner makes sure that the structure fits the digital design file. Robotic milling and spraying arms then add detail and functionality. Because the construction material hardens quickly, a roof, additional insulation, and exterior features can all be added during the initial fabrication process.
The homes slated for Rancho Mirage in the Coachella Valley area of California will feature mid-century contemporary design and include three bedrooms and two bathrooms inside 1,450 square feet. A second, smaller residence on the same 10,000 square-foot plot of land will feature two bedrooms and one bathroom.
Each lot will feature a swimming pool and optional amenities, including fire pits, hot tubs, and cabanas. Prices have been set at $595,000 for a basic primary residence model, and increase to $950,000 for a deluxe, two-home property.
Mighty Buildings said the project is focused on providing housing options for the housing markets "missing middle": teachers, firefighters and others who serve their community, but who cannot afford a suitable home due to sky-high California real estate costs.
Hanaphy, P. Scientists create fully-automated 3D printed prosthetic production line. 3D Printing Industry. [Online] Available at: https://3dprintingindustry.com/news/scientists-create-fully-automated-3d-printed-prosthetic-production-line-185892/
Paul, K. 'The future of housing': California desert to get America's first 3D-printed neighborhood. The Guardian. [Online] Available at: https://www.theguardian.com/technology/2021/mar/18/california-housing-coachella-3d-printed-houses
Disclaimer: The views expressed here are those of the author expressed in their private capacity and do not necessarily represent the views of AZoM.com Limited T/A AZoNetwork the owner and operator of this website. This disclaimer forms part of the Terms and conditions of use of this website.
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Logistics Automation Market by Component, Function, Organization Size, Vertical and Region – Global Forecast to 2026 – ResearchAndMarkets.com -…
Posted: at 6:37 am
DUBLIN--(BUSINESS WIRE)--The "Logistics Automation Market by Component, Function (Warehouse and Storage Management, Transportation Management), Organization Size (SMES, Large Enterprises), Vertical (3PL, Retail and Ecommerce, FMCG, Manufacturing), and Region - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.
The global logistics automation market size is projected to grow from USD 48.4 billion in 2020 to USD 88.9 billion by 2026, at a Compound Annual Growth Rate (CAGR) of 10.6% during the forecast period.
The logistics automation market is gaining traction due to digital transformation in the logistics industry, emergence of IoT, exponential growth in the eCommerce industry, advancements in robotics, and growing need to ensure workforce safety.
Based on Function, the warehouse and storage management segment is expected to hold a larger market share during the forecast period
The warehouse and storage management segment is projected to account for a larger market share in 2020 to 2026. The rising need to optimize warehouse spaces and distribution centers is fuelling the importance of warehouse and storage management function. An effective warehouse management system ensures the efficient execution of warehousing operations, such as receiving, slotting, picking, and shipping. This system can process large amounts of data and coordinate movements within the warehouse, which in turn, helps in the efficient management of the supply chain network of a company. Thus, warehouse operating companies are adopting warehouse and storage management solutions to manage inventory by streamlining storage and distribution operations.
Based on Organization size, the SMEs segment to grow at the highest CAGR during the forecast period
SMEs are focused on the deployment of logistics automation solutions to improve competitiveness and reduce operating costs. Despite the high cost involved in automating logistics processes, the adoption of logistics automation solutions provides long-term RoI. However, due to limited budgets, SMEs are unable to automate logistics processes fully. With advancements in automation technology and intense competition among vendors, the cost of automating warehouses is declining. This, in turn, will enable SMEs to adopt automation solutions and services in the near future. Furthermore, the adoption of cloud-based logistics automation software is expected to rise in SMEs as they require only necessary functions and features for small-scale warehouse operations.
Asia Pacific (APAC) region to record the highest growth in the logistics automation market
North America is expected to hold the largest market share during the forecast period and APAC is expected to grow at the highest CAGR during the forecast period. APAC is transforming dynamically with respect to the adoption of new technologies across various sectors, especially in China, Japan, India, and ANZ. These countries have always supported and promoted industrial and technological growth. Also, they possess a developed technological infrastructure, which is promoting the adoption of logistics automation solutions across all industry verticals. Moreover, the eCommerce companies in the region are investing in improving their supply chain network and logistics processes through the adoption of logistics automation solutions. Global companies are significantly investing in the manufacturing, automobile, retail, and healthcare industries in the region. Further, the expansion of the transportation and logistics industry and the increase in trade agreements are key factors projected to drive the growth of the logistics automation market in APAC.
Market Dynamics
Drivers
Restraints
Opportunities
Challenges
Companies Mentioned
For more information about this report visit https://www.researchandmarkets.com/r/erxpv
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Global Building Automation and Controls Market (2020 to 2027) – Opportunity Analysis and Industry Forecasts – ResearchAndMarkets.com – Business Wire
Posted: at 6:37 am
DUBLIN--(BUSINESS WIRE)--The "Building Automation and Controls Market by Product Type, Offering and Industry Vertical: Global Opportunity Analysis and Industry Forecast, 2020-2027" report has been added to ResearchAndMarkets.com's offering.
The global building automation and controls market is expected to reach $215.59 billion by 2027 from $101.91 billion in 2019, growing at a CAGR of 11.10% from 2020 to 2027.
Building automation and controls system is an automaticcentralized control system. This system finds application for heating, ventilation, & air conditioning, lighting, and security & access control. Increased demand for energy efficiency and maintaining a secure & safe environment with enhanced user convenience in various industry verticals, such as industrial, enterprises, retail, hospitality, residential, and others, boost the market growth.
The major players in the building automation and controls market are Siemens and Honeywell. This report features information on intelligent building solutions offered by key vendors. Furthermore, the report also highlights the strategies of the market players to improve their market share and sustain the competition.
The global building automation and controls market is expected to witness significant growth during the forecast period, owing to the surging need for advanced energy-efficient interventions, growing deployment of building automation systems, and rise in demand for convenient user experience. Moreover, constant development of the supportive regulatory structure and legislative requirements fuel the demand for intelligent building solutions.
In addition, development of smart cities in emerging countries and government initiatives are expected to boost the growth of the building automation and controls market in the coming years. However, lack of interoperability between devices hampers the growth of the building automation and controls market.
The global building automation and controls market is segmented on the basis of product type, offering, industrial vertical, and region. On the basis of product type, the market is divided into HVAC control, lighting control, and security & access control. Based on offering, it is bifurcated into integration and services. Based on industry vertical, it is classified into residential, enterprise, industrial, hospitality, retail, and others.
Region-wise, the building automation and controls market trends are analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, the UK, France, Italy, and Rest of Europe), Asia-Pacific (China, Japan, India, South Korea, and Rest of Asia-Pacific), and LAMEA (Latin America, the Middle East, and Africa). Europe accounted for the highest share, owing to the development of wireless technology and increase in construction of smart cities.
Market Dynamics
Drivers
Restraint
Opportunities
Key Players
For more information about this report visit https://www.researchandmarkets.com/r/oyb1eh
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H Mart partners with AutoStore to deploy automated micro-fulfillment center – Modern Materials Handling
Posted: at 6:37 am
H Mart, an Asian-American specialty grocer, has partnered with AutoStore, the Norwegian robotics technology company, in collaboration with Bastian Solutions, to introduce a fully automated micro-fulfillment center to support H Marts online grocery operations in Carlstadt, New Jersey.
Hmart.com has proven to be an important offering to our customers, said Vince Colatriano, Executive Vice President of H Mart. Hmart.com enables our customers to experience the food that lets them feel at home, just as when they shop in-store. Weve partnered with the best automated technology in the field to fulfill our orders quickly and efficiently. Were excited to work with Bastian Solutions and AutoStore to deliver the highest quality Asian products to our customers
AutoStores robotics and WMS technologies combine to provide retailers with a complete MFC solution, increasing fulfillment efficiency for a broad range of grocery packaged goods along with fresh and frozen items. AutoStore states its MFC solution is flexible and scalable, and can even be installed at the back of a store. This enables retailers to reduce the average distance between an MFC and their customer, allowing for both in-store pickup and rapid home delivery.
As a global partner, weve worked on numerous installations that are successfully operating with the award-winning AutoStore system. We look forward to integrating AutoStores robotics and e-grocery WMS with H Marts operations for faster order fulfillment and increased customer satisfaction, said Aaron Jones, President of Bastian Solutions.
H Marts investment in e-grocery automation will not only help the bottom line of their online business but will also benefit their customer base as a whole. Were excited to work with Bastian Solutions in providing H Mart a solution that gives them greater operational efficiency and order accuracy, so customers receive exactly what they ordered, added Mike Demko, the head of AutoStores MFC business line.
Projects like these will change retail forever, and we are very pleased that H Mart chose AutoStore and Bastian Solutions to deliver the future of e-grocery, said Karl Johan Lier, CEO of AutoStore.
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IntelePeer and Enghouse Interactive Collaborate to Create Automated COVID-19 Vaccination Scheduling Solution for Rural Areas – Business Wire
Posted: at 6:37 am
SAN MATEO, Calif.--(BUSINESS WIRE)--IntelePeer, a leading Communications Platform as a Service (CPaaS) provider, and Enghouse Interactive, a leading global contact center and video solutions provider, have partnered to deploy an inbound COVID-19 vaccine scheduling hotline for households that may have trouble scheduling via the internet. The two companies joined forces to create a hotline scheduling solution with geographic routing capabilities, diligently offering vaccine-eligible residents the ability to get an appointment while also helping over 700 contact center agents work more efficiently to increase scheduling despite working from home.
According to a February 2021 Kaiser Family Foundation research project, four in ten adults over the age of 65 said it was difficult to get a vaccine appointment and the FCC estimates 21 million Americans do not have online access. With these troubling statistics in mind, IntelePeer and Enghouse Interactive collaborated to fast-track a COVID-19 hotline to provide those without internet access or who are not considered digitally literate, an easy solution to help schedule vaccines effectively removing the digital divide that has slowed the U.S. vaccine roll-out.
It was critical to help solve heavy inbound calling for residents qualifying to receive the COVID-19 vaccine. By implementing an automated voice solution via a hotline, residents were able to receive information they needed to eliminate the risk of confusion, long hold times, busy signals or dropped calls and bring a positive experience while scheduling to receive the vaccine, said David Thomas, General Manager at Enghouse Interactive, Americas. Working with IntelePeer allowed us to respond in a rapid manner to get our Enghouse CCaaS solution, backed by IBMs Cloud Infrastructure, activated across nine participating contact center groups, comprised of community businesses and volunteers offering remote agent resources and experience.
Prior to this automated solution, calls went to one system and overwhelmed it with information, leading to long wait times or dropped calls. IntelePeers Atmosphere CPaaS and its geographic routing and with its easy to use Atmosphere SmartFlows communication workflow designer have given contact centers the ability to pre-screen based on vaccine qualification criteria for intelligent routing to the right contact center agent. The system also reacts quickly to changes in vaccine availability and can update callers about open vaccine appointments.
As IntelePeer seeks to assist healthcare providers, states, businesses and the underserved public during this crucial time, Enghouse provides added strength and nimbleness as a contact center software partner, said Jeremy Jones, Chief Commercial Officer at IntelePeer. Thanks to their expertise we were able to build and launch a hotline that can meet a high volume of inbound calls and provide a solution that is easy to use, universally available, and improved residents overall experience.
To learn more about how IntelePeer and Enghouse Interactive are helping with COVID-19 Vaccine Distribution, please call 1-855-462-6819.
About Enghouse Interactive
Enghouse Interactive (EI) is a leading global contact center and video solutions provider that has been serving thousands of customers for over 35 years. EI solutions enable customers to deliver winning customer experiences by transforming the contact center from a cost center into a powerful growth engine. EI core values Reliability and Choice are key differentiators in the global marketplace. Reliability speaks to EIs reputation for always honoring commitments to customers, staff, partners and investors. Choice is reflected in the unparalleled breadth of its CX portfolio, which enables customers to choose from a wide array of solutions and consulting practices, whether deployed on-premises, in the cloud or on a hybrid platform. By providing a broad range of technologies and capabilities based on open standards, EI simplifies the advanced integrations that customers require.
About IntelePeer
IntelePeer powers the new customer experience. Our Atmosphere CPaaS enables companies to communicate better driving more revenue, improving their customer experience, and making better business decisions leveraging omni-channel Automation & Self-Service, AI, and Analytics, all delivered through a single easy-to-use cloud platform that works seamlessly with your existing business solutions. For more information visit: http://www.intelepeer.com
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Dna | Definition of Dna at Dictionary.com
Posted: at 6:36 am
DNA is a large, complex molecule that allows cells to function and carries the genetic code that determines the traits of a living organism.
DNA is in every cell of every living thing. Some viruses also have DNA.
Life as we know it wouldnt exist without DNAit contains the instructions that cells need to function. DNA is found in the cell nucleus, and every cell in an organism has the exact same copy of DNA that is in every other cell. Each cell uses its copy of DNA whenever it needs to make a protein. Proteins have many essential jobs within a living thing. For example, your immune system produces proteins called antibodies to fight germs.
The information thats in DNA controls the development of specific traits, such as the shape of a leaf or the color of hair. Specifically, such traits are determined by genes, which are segments of DNA within strands called chromosomes. The set of all information contained in the DNA of any living thingall of its inheritable traitsis called its genome.
DNA is an abbreviation of deoxyribonucleic acid. It is a type of macromolecule (a very large moleculeone composed of hundreds of thousands of atoms) known as a nucleic acid. Nucleic acids are made of smaller molecules known as nucleotides, which are made of a phosphate, a sugar, and nitrogen bases. The four nitrogen bases in DNA are adenine (A), thymine (T), guanine (G), and cytosine (C).
DNA has a shape known as a double helix, which resembles a spiraled ladder. The DNA ladder is built from two very long strands of nucleotides with the nitrogen bases pairing together to form the rungs of the ladder. The bases form base pairs, with adenine always paired to thymine and guanine always paired to cytosine. The phosphate and sugar within the nucleotide act as the sides of the ladder.
Because DNA only exists within the cells nucleus, the genetic information must be distributed somehow. This is one of the roles of RNA, which is a macromolecule that works alongside DNA to make proteins. During this process, RNA acts as a kind of copy of the DNA that carries its genetic information outside of the cell nucleus.
We took a microscopic look at the differences between DNA, RNA, and mRNA, and their vital roles. Read all about it here!
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Vaccine Ingredients DNA | Children’s Hospital of …
Posted: at 6:36 am
DNA can be a concern related to vaccines in two ways because it is the vacciness active ingredient, such as in adenovirus-based vaccines, or as a manufacturing byproduct following growth of vaccine virus in human fetal cells.
Because adenoviruses are DNA viruses, when they are used as a delivery vehicle during vaccination, the active ingredient is also DNA. This causes some to wonder whether the DNA delivered during vaccination can alter a persons DNA. In short, the answer is no. The reason that a persons DNA cannot be changed is that a necessary enzyme, called integrase, is not present.
We can be further reassured by the fact that when people get a cold from an adenovirus infection, the adenovirus cannot alter their DNA. As a family of viruses, this is not a role they can play.
Some people wonder whether the vaccines made using human fetal cells (chickenpox, rubella, hepatitis A, one version of the rabies vaccine, and one version of the COVID-19 vaccine) could cause harm if the DNA from the fetal cells mixes with the vaccine recipients DNA. This is not likely to happen:
Read more about the use of human fetal cells.
Yang H, Wei Z, Schenerman M. A statistical approach to determining criticality of residual host cell DNA.J Biopharm Stat 2015;25:234-246.The authors proposed a method for determining the quantity of residual host cell DNA regarding oncogenicity and infectivity. The authors created an equation to estimate the risk and applied that equation to a cell-based influenza vaccine manufactured using Madin Darby Canine Kidney (MDCK) cells. The calculated probability of having one cancer-causing or infective event based on the WHO/FDA limits is less than 10-15. If using limits of 800 base pairs and 40 ng DNA/dose, the risk is estimated to be 4.6 x 10-7.
Yang H.Establishing acceptable limits of residual DNA. PDA J Pharm Sci Technol 2013; 67(2):155-163.The author conducted a risk assessment on the WHO and FDA guidelines that recommended 10 ng/dose and 200 base pairs as the limits of residual DNA in the final biological product. The safety margin is defined as the number of doses needed to induce a cancer-causing or infective event in recipients. The author suggested that current safety margin estimates do not take into account DNA fractionation or DNA enzymatic inactivation. By incorporating the number of unfragmented potential cancer genes and accounting for DNA enzymatic inactivation, the author suggests that a more accurate safety margin can be calculated and that higher DNA content or base pair size would be acceptable.
Yang H, Zhang L, Galinski M. A probabilistic model for risk assessment of residual host cell DNA in biological products. Vaccine 2010;28:3308-3311.The authors assessed the cancer-causing and infective potential of residual DNA from a cell-based live, attenuated influenza vaccine that is manufactured in Madin Darby Canine Kidney (MDCK) cells. They determined that 230 billion doses of vaccine would need to be administered before a potential cancer gene dosage equivalent would be reached, and 83 trillion doses would need to be administered to induce an infective event.
Knezevic I, Stacey G, Petricciani J, et al.WHO Study Group on cell substrates for production of biologicals, Geneva, Switzerland, 11-12 June 2007. Biologicals 2008;36:203-211.The WHO Expert Committee on Biological Standardization adopted requirements for the use of animal cells as substrates for the production of vaccines and other biologicals in 1996. In 2006, a WHO Study Group on Cell Substrates was formed to initiate revision of WHO requirements. In 2007, the Study Group agreed that data generated on the possibility of cancer or an infection caused by DNA in vaccines were important in defining potential risk for vaccine recipients. It was considered highly likely that reduction of DNA fragment size reduced the risk from DNA and increased the safety margin, as the smaller the DNA fragments, the lower the probability that intact oncogenes and other functional sequences would be present. Studies performed at the Center for Biological Evaluation and Research (CBER) suggest that DNA fragments smaller than 200 base pairs will give substantial safety margins for products that meet the 10 ng/dose limit. Therefore, the margin of safety for vaccines can be found in the high fragmentation, and therefore very small size, of DNA.
WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals. Biologicals 1998;26:175-193.Cell lines of human (e.g., WI-38, MRC-5) or monkey (FRhL-2) origin are non-tumorigenic and residual cellular DNA derived from these cells has not been, and is not, considered to pose any risk. Continuous cell line (CCL) substrates of human origin such as HeLa cells (derived from cervical cancer cells) or Namalva cells (derived from Burketts lymphoma) could have the potential to confer the capacity for unregulated cell growth or tumorigenic activity upon other cells. Risk assessment based on an animal oncogene model suggested that in vivo exposure to 1 ng (one-billionth of a gram) of cellular DNA where 100 copies of an activated cancer gene were present in the genome could give rise to a cancer-causing event 1 per 1 billion recipients. The risk associated with residual CCL DNA in a product is negligible when the amount of such DNA is 100 pg (a picogram is one-trillionth of a gram), which is the current maximal amount of CCL DNA allowed by the FDA.
Wierenga DE, Cogan J, Petricciani JC. Administration of tumor cell chromatin to immunosuppressed and non-immunosuppressed non-human primates. Biologicals 1995;23:221-224.The authors addressed the issue of how risky DNA may be as a residual impurity by injecting both normal and immunosuppressed monkeys with 100 million genome equivalents of DNA from a human tumor cell line that is one million times the DNA (1 mg) allowed by WHO in a single dose of biological product (100 pg). DNA from a human tumor, saline, or cyclosporine doses were administered intravenously, intramuscularly, or intracerebrally on either a daily, weekly or one-time basis. Animals were observed for 8 years, none of which showed any evidence of tumor formation.
Lower J. Risk of tumor induction in vivo residual cellular DNA: quantitative considerations. J Med Virol 1990;31:50-53.In 1987, the WHO Study Group compiled a list of experiments in which DNA of tumor viruses or DNA of the corresponding cancer genes were injected into experimental animals to determine the amount required to induce tumors in half of those tested. In this study, the author compared that information with the recommended residual cellular DNA limits (100 pg) in CCL biological products. The author determined that the number of cancer genes in 100 picograms cellular DNA is less than one-billionth of the amount needed to induce tumors in experimental animals.
Temin HM. Overview of biological effects of addition of DNA molecules to cells. J Med Virol 1990;31:13-17.A maximum cumulative probability of having a harmful effect is calculated to be less than 10-16to 10-19 per DNA molecule from a cell without activated precursor cancer genes or active viral cancer genes.
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DNA vaccines – WHO
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Vaccination consists of stimulating the immune system with an infectious agent, or components of an infectious agent, modified in such a manner that no harm or disease is caused, but ensuring that when the host is confronted with that infectious agent, the immune system can adequately neutralize it before it causes any ill effect. For over a hundred years vaccination has been effected by one of two approaches: either introducing specific antigens against which the immune system reacts directly; or introducing live attenuated infectious agents that replicate within the host without causing disease synthesize the antigens that subsequently prime the immune system.
Recently, a radically new approach to vaccination has been developed. It involves the direct introduction into appropriate tissues of a plasmid containing the DNA sequence encoding the antigen(s) against which an immune response is sought, and relies on the in situ production of the target antigen. This approach offers a number of potential advantages over traditional approaches, including the stimulation of both B- and T-cell responses, improved vaccine stability, the absence of any infectious agent and the relative ease of large-scale manufacture. As proof of the principle of DNA vaccination, immune responses in animals have been obtained using genes from a variety of infectious agents, including influenza virus, hepatitis B virus, human immunodeficiency virus, rabies virus, lymphocytic chorio-meningitis virus, malarial parasites and mycoplasmas. In some cases, protection from disease in animals has also been obtained. However, the value and advantages of DNA vaccines must be assessed on a case-by-case basis and their applicability will depend on the nature of the agent being immunized against, the nature of the antigen and the type of immune response required for protection.
The field of DNA vaccination is developing rapidly. Vaccines currently being developed use not only DNA, but also include adjuncts that assist DNA to enter cells, target it towards specific cells, or that may act as adjuvants in stimulating or directing the immune response. Ultimately, the distinction between a sophisticated DNA vaccine and a simple viral vector may not be clear. Many aspects of the immune response generated by DNA vaccines are not understood. However, this has not impeded significant progress towards the use of this type of vaccine in humans, and clinical trials have begun.
The first such vaccines licensed for marketing are likely to use plasmid DNA derived from bacterial cells. In future, others may use RNA or may use complexes of nucleic acid molecules and other entities. These guidelines address the production and control of vaccines based on plasmid DNA intended for use in humans. The purpose of these guidelines is to indicate:
It is recognized that the development and application of nucleic acid vaccines are evolving rapidly. Thus, their control should be approached in a flexible manner so that it can be modified as experience is gained in production and use. The intention of these guidelines is to provide a scientifically sound basis for the production and control of DNA vaccines intended for use in humans, and to assure their consistent ssafety and efficacy. Individual countries may wish to use these guidelines to develop their own national guidelines for DNA vaccines
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