Cell and gene therapy manufacturing may never be standardized but the whole industry would gain if firms collaborated to develop common methods for some processes according to an expert.
Manufacturing cell and gene therapies is an expensive business, partly because no two products are made the same way.
A recent study in the journal Nature suggested the average cost of making an autologous cell therapy is between $100,000 and $300,000 per patient.1
The authors attributed the high cost to the use of novel and specialized manufacturing processes [which] make scaling to meet commercial demand a significant challenge for all.
A separate study in the Journal of Clinical Oncology also concluded that difficulties scaling-up the bespoke manufacturing processes and technologies used to make cell and gene therapies significantly increases production costs.2
Market tensions
And high costs are a problem, according to Maria Whitman, managing principal at consulting firm, ZS Associates, who said cell and gene therapy firms need to find more economic ways of making products.
Standardization in manufacturing across the industry is not likely to be the priority for standardization in the short termHowever, the in-market cell and gene therapies have illuminated a number of tensions in the U.S. healthcare system which was designed for pills and biologics.
With over 200 CAR-TCR trials alone in the United States, there is need for standardization of aspects of the process to enable scale and commercial viability of these technologies. The challenge is that, today, each manufacturer is in part by necessity establishing their own process and protocols, she said.
The key is to look for similarities in processes, according to Whitman.
Potential areas for manufacturing and logistical standardization include apheresis protocols, labeling and information management, tracking processes, and training certifications, she said.
Whitman suggested contract manufacturers could help to identify common manufacturing challenges if customers are willing to work together and share information about noncompetitive areas of production.
The process question we should be asking as an industry is this: what is really competitive IP, and what is not? If we answer that, we can identify and solve for more systemic needs.
Logistics is another area where standardization would benefit the sector, Whitman added, citing developers of autologous therapies as the obvious example.
Autologous cell therapies are produced from the patients own cells. Typically the cells are harvested at a clinic and transported to the manufacturing facility before being returned to the patient. Ensuring such therapies are delivered in a timely fashion is vital.
According to Whitman, Manufacturers are trying multiple approaches to streamline the logistics of distance between manufacturing and patient administration. Some are developing in-house solutions and technology or leveraging partnerships to minimize risks and timing.
There is also a new industry emerging of companies forming to solve specific issues including apheresis networks, product manufacturers, as well as companies that create ordering portals, supply chain management systems.
One approach is to localize manufacture. Whitman said, There are already a number of manufacturers working on technologies to make point-of-care cell therapy a reality. Some academics are also creating their own CAR-TCRs, for example, and running trials in parallel with traditional manufacturer trials.
Ultimately the growth of the cell and gene therapy sector will depend on manufacturers ability to balance production and logistics costs with product prices. And the desire to find such a balance is clear, Whitman said.
Manufacturers will look for ways to optimize and automate the process where possible to reduce the cost of skilled human labor and continue to remove risk and drive efficiency in the system.
References1. http://www.nature.com/articles/s41434-019-0074-72. hascopubs.org/doi/10.1200/JCO.18.02079
The rest is here:
IP or Not IP: That Is the Question for Cell and Gene Therapy Sector - Genetic Engineering & Biotechnology News
- The Feedback Loop: Ecological Damage Soon Beyond Control [Last Updated On: August 17th, 2024] [Originally Added On: June 16th, 2011]
- Human Genetic Engineering [Last Updated On: August 17th, 2024] [Originally Added On: October 10th, 2011]
- GENETICS ENGINEERING RESEARCH AT IUSOM - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 13th, 2011]
- Genetic Manipulation And Its Impact On The Human Species 5/8 - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 13th, 2011]
- Genetic Engineering: Do or Die (Chapter 1) - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 14th, 2011]
- Genetic Minipulation Replacments Humans and Disclosure. - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 14th, 2011]
- Genetic Engineering - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 16th, 2011]
- Homo Sapiens are a Product of Alien Genetic Engineering - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 16th, 2011]
- China Engineers Genetically Modified Cows To Produce Human Breast Milk - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 17th, 2011]
- Genetic Engineering on Children has already begun - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 22nd, 2011]
- The Coming Replacement Humans - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 22nd, 2011]
- Genetically Engineering Intelligent Babies - Horizon: Are We Still Evolving? Preview - BBC Two - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 22nd, 2011]
- Prof. Stuart Newman on human genetic modification (Pt.2) - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 22nd, 2011]
- The Ethics of Genetically Engineering Children - Arthur Caplan - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 24th, 2011]
- 2012 UFO's ALIEN HUMANS GENETICALLY ENGINEERED BY ALIEN RACE LLOYD PYE - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 24th, 2011]
- First Human Drug from Genetically Engineered Animals Approved - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 24th, 2011]
- The Known Genome Of Species - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 25th, 2011]
- Engineering Our Children - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 25th, 2011]
- GENETIC ENGINEERING HUMANITY INTO A LIVING HELL (3 OF 4) - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 27th, 2011]
- Monsanto's Crimes Against Humanity with Jeffrey M. Smith P 1-2 - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 28th, 2011]
- Genetic Modification - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 28th, 2011]
- Papers On Ethical Issues, ethical issues , the office ethical , The Office Ethics - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 1st, 2011]
- Lloyd Pye - Ancient Genetic Engineering - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 3rd, 2011]
- GENETIC ENGINEERING HUMANITY INTO A LIVING HELL(1 OF 4) - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2011]
- NWO SUPER HUMANS - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 10th, 2011]
- Damn Dirty Humans (Apes-vs-Robots @ Movie Smackdown!) - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 25th, 2011]
- Alex Jones - David Icke: The Blue Bloods [Last Updated On: August 17th, 2024] [Originally Added On: November 25th, 2011]
- Genetically modified cow for human breast milk (10 Jun 2011) - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 25th, 2011]
- Barcode Babies And The Bio-Engineering of Humanity - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 25th, 2011]
- Resident Evil Operation Raccoon City - Kill Leon S. Kennedy Trailer [1080p HD PS3, Xbox 360, PC] - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 25th, 2011]
- Resident Evil Operation Raccoon City - E3 2011 gameplay part 2 Trailer [1080p HD PS3, Xbox 360, PC] - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 25th, 2011]
- Animal/human hybrid experimentation in ancient times - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 25th, 2011]
- Genetic Engineering - Knowledge Base | Lecture 1.0 - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 3rd, 2011]
- PANDEMONIUM'S ENGINE - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 3rd, 2011]
- Resident Evil Operation Raccoon City - E3 2011 gameplay part 1 Trailer [1080p HD PS3, Xbox 360, PC] - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 3rd, 2011]
- Interview with James M. Wilson, MD, Ph.D. (U. Penn) - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 3rd, 2011]
- Marshall Klarfeld - The Extraterrestrial Origins of Humanity - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 3rd, 2011]
- # 834 10 Ways the Scientific Dictatorship Aims to Modify Human Beings - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 7th, 2011]
- Human Genetic Engineering 1.mov - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 10th, 2011]
- Human Genetic Engineering English Final Bryan Hatchell - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 10th, 2011]
- Genetic Engineering for Human Enhancement.mp4 - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 16th, 2011]
- Human Genetic Manipulation - Video [Last Updated On: August 17th, 2024] [Originally Added On: December 19th, 2011]
- The Truth About Lost Mittens - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 1st, 2012]
- Human Hybrids - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 14th, 2012]
- Human Genetics: Human Accelerated Regions in the Genome - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- Resident Evil Operation Raccoon City - Story and gameplay Trailer [1080p HD PS3, Xbox 360, PC] - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- # 831 We Need to Wake Up to This Too! Human/Alien Hybridization - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- Alex Jones - The Globalist Biological Warfare Plan for All Humanity 1_4! - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- Alex Jones - The Globalist Biological Warfare Plan for All Humanity 2_4! - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- Spare Parts for Humans: Tissue Engineers Aim for Lab-Grown Limbs, Lungs and More - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- Grey Aliens - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- Human Giants [Last Updated On: August 17th, 2024] [Originally Added On: January 16th, 2012]
- Has the modern science found evidence that the homo-sapiens species was jumpstarted by aliens? - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 19th, 2012]
- Viruses con bacteria into working for them [Last Updated On: August 17th, 2024] [Originally Added On: January 29th, 2012]
- New Genetics and Microbiology Resources Published at ScienceIndex.com [Last Updated On: August 17th, 2024] [Originally Added On: January 29th, 2012]
- CURL: The end of the GOP as we knew it [Last Updated On: August 17th, 2024] [Originally Added On: January 30th, 2012]
- Delphi Genetics: The New DNAVAC Research Project Targets the Removal of Antibiotics in Veterinary DNA-Vaccine ... [Last Updated On: August 17th, 2024] [Originally Added On: January 30th, 2012]
- Experts Weigh in on Bird Flu Research [Last Updated On: August 17th, 2024] [Originally Added On: January 31st, 2012]
- Cellectis Plant Sciences Announces the Signature of a Strategic Partnership with SESVanderHave in Sugar Beet [Last Updated On: August 17th, 2024] [Originally Added On: January 31st, 2012]
- Plant Physiologist Helen Stafford leaves Reed College Biology Dept. $1M [Tomorrow's Table] [Last Updated On: August 17th, 2024] [Originally Added On: February 1st, 2012]
- Hepatitis Research May Benefit From Stem Cells [Last Updated On: August 17th, 2024] [Originally Added On: February 5th, 2012]
- James A. Shapiro: Purposeful, Targeted Genetic Engineering in Immune System Evolution [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- EDITORIAL Focus on what’s important [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- Resident Evil Operation Raccoon City - Triple threat cinematic Trailer [1080p HD PS3, Xbox 360, PC] - Video [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- COMMUNICATION WITHOUT WORDS - Video [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- Resident Evil Operation Raccoon City - Heroes mode Trailer [1080p HD PS3, Xbox 360, PC] - Video [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- Global Food Crisis to Spur Sturdy Growth of Genetically Engineered Crops, According to New Report by Global Industry ... [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- Hybrids [Last Updated On: August 17th, 2024] [Originally Added On: February 12th, 2012]
- Cure of ADPKD by selection for spontaneous genetic repair events in Pkd1-mutated iPS cells [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- Lab-Made Neurons Allow Scientists To Study A Genetic Cause Of Parkinson's [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- Not as Easy as it Sounds [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- Siemens partners with drugmakers [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- Scientists concerned about antibiotic resistance in wastewater [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- U-M human embryonic stem cell line placed on national registry [Last Updated On: August 17th, 2024] [Originally Added On: February 15th, 2012]
- U-M Human Embryonic Stem Cell Line Placed On National Registry for Researchers [Last Updated On: August 17th, 2024] [Originally Added On: February 15th, 2012]
- UM Human Embryonic Stem Cell Line Placed On National Registry [Last Updated On: August 17th, 2024] [Originally Added On: February 15th, 2012]
- World Economic Forum lists top 10 emerging technologies for 2012 [Last Updated On: August 17th, 2024] [Originally Added On: February 16th, 2012]
- Nanosurgery and the fight against cancer: major breakthrough at Polytechnique Montréal [Last Updated On: August 17th, 2024] [Originally Added On: February 16th, 2012]
- The splice of life: Proteins cooperate to regulate gene splicing [Last Updated On: August 17th, 2024] [Originally Added On: February 16th, 2012]
- Proteins cooperate to regulate gene splicing [Last Updated On: August 17th, 2024] [Originally Added On: February 16th, 2012]