Cell and gene therapy (CGT) manufacturers can struggle to move from lab-scale to clinical-scale production. Automation can help but, to make a success of the transition, developers must be willing to learn from other industries.
So says Josh Ludwig, global director of commercial operations at ScaleReady, a joint venture between Bio-Techne, Fresenius Kabi, and Wilson Wolf, who believes a lack of scale-up expertise is the issue.
“The biggest challenge CGT manufacturers face is the need to quickly create a viable manufacturing operation that can scale out practically as clinical patient demand increases. As things currently stand, CGT companies are poorly equipped to recognize how to establish scalability or meet the need for speed.
“Establishment of a viable manufacturing operation requires detailed knowledge that is not present in the CGT field. Well-understood principles and methods are found throughout hundreds of industries, but they are foreign to the field of CGT. The most basic aspects of efficient manufacturing are missing,” he tells GEN.
Ludwig points to the automotive and medical device industries as examples of sectors that are well-versed in the steps needed for effective scaleup.
“Over decades, highly competitive regulated industries that have to make thousands of products or more, like cars or medical devices, have developed systems and processes that are highly effective at manufacturing scale out with high quality and exceptional efficiency. Unfortunately, the CGT industry has failed to employ people that have this kind of deep knowledge and experience.”
Clinical data focus
Another issue is the fact many CGT developers are venture capital backed, rather than revenue-generating. This funding structure can mean there is pressure to develop production processes sufficient to support early-phase development rather than late-stage trials and commercialization.
Ludwig says: “All too often, CGT fail to create the systems and processes to make drug products in a practical and scalable manner before time and money run out. Even if a manufacturing process is created and clinical data is obtained, the process is virtually certain to be inadequate at late-stage clinical or commercial scale.”
In addition, some venture-funded CGT companies coming out of academia fail to recognize the benefit of hiring people with deep know-how and experience in efficiently manufacturing products at scale.
“Instead, they hand their manufacturing process off to people with a solid academic pedigree in a biological-related science, maybe a couple of stints at other CGT companies, with a total manufacturing experience of making less than 100 products,” Ludwig adds.
Automation
In Ludwig’s view automation can solve many of the challenges involved in making cell and gene therapies. However, using automated systems correctly also requires expertise.
“The reality is that there are many entities talking about automation, and it will have its place someday. However, until there are true manufacturing people from other industries that are welcomed into the CGT field, it will be misapplied.
“The good news is that CGT drug product manufacturing is a liquid handling problem and that makes it ideal for automation,” he continued, adding “When automation is applied properly to this industry, it will resemble the current processes of producing household goods such as hand soap to commonly used drugs such as insulin.”
https://www.genengnews.com/topics/bioprocessing/automation-and-knowhow-vital-for-cell-and-gene-therapy-scaleup/
Check out our AAV CDMO service to expedite your gene therapy research
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
Related News
Skyline Therapeutics Receives FDA Orphan Drug Designation for Gene Therapy for Retinitis Pigmentosa
BOSTON & SHANGHAI, September 2, 2024 – Skyline Therapeutics, a gene therapy company focused on innovative treatments for rare and severe diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SKG1108....
Novavax Receives Emergency Use Authorization for Updated Covid-19 Vaccine
Novavax has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its updated Covid-19 vaccine, NVX-CoV2705, joining other vaccine manufacturers in addressing evolving virus variants. The EUA permits the use of Novavax's...
Turn Biotechnologies Reports Historic Skin Cell Rejuvenation Breakthroughs at ESDR this Week
Company will present data from its successful rejuvenation of fibroblasts and keratinocytes to influential gathering of international dermatologists MOUNTAIN VIEW, Calif., Sept. 4, 2024 /PRNewswire/ -- Turn Biotechnologies, a developer of novel mRNA medicines and...
H5 influenza vaccines: What needs to be done to reduce the risk of a pandemic
As the global threat of H5N1 influenza looms with outbreaks across species and continents including the U.S., three international vaccine and public health experts say it is time to fully resource and support a robust strategy to address this and future potential...
Related Services
Plasmids GMP Services
AAV GMP Services
