Gene Therapy Process Development
You need a partner with a proven track record of advancing gene therapy product development and manufacturing, and the ability to adapt to your needs. As your trusted expert in life science, we provide optimized viral vector manufacturing platforms, packaging cell lines, media and reagents, characterization tools, and testing – all required to tackle the bottlenecks of gene therapy commercialization.
Our Gene Therapy Process Development Services allow you to:
- Accelerate successful research into scalable, industrialized processes
- Increase patient access through cost-effective, robust manufacturing
- Remove subjectivity and operator error through closed and automated processes
- Reduce the time to bring your therapy to clinical trials and commercialization, based on our technical expertise and knowledge transfer
Process Development
Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve yield and quality of your viral vectors. Our PD capabilities include different upstream bioprocessing and downstream purification approaches involving various virus types and diverse modes of adherent or suspension cultures. The breadth of our experience allows us to develop robust production processes to move your gene therapy products quickly through clinical trials and to commercialization.
Technical Transfer
We have established a full tech transfer team to ensure successful knowledge transfer and scaling-up of developed production/purification processes for cGMP manufacturing. The tech transfer team delineates acceptance criteria for engineering and cGMP programs, working collaboratively with our manufacturing team and clients. We have averaged more than twenty new tech transfer projects annually and have helped clients achieve faster speed-to-market.
To learn more about our Process Development Services for gene therapy manufacturing, contact us today.
Our extensive expertise and manufacturing experience make us an ideal partner to advance and translate your work to gene therapy success. Connect with us today to discuss your specific application.
External Resources
Manufacturing costs present a key challenge to gene therapy commercialization. Cost Modeling can help make informed decisions to reduce manufacturing costs. Discover 3 key insights in this video.
Costly mistakes can happen when rushing through process development to produce curative therapies for genetic diseases. Learn about 3 key strategies that can be leveraged to improve product yield, quality, and patient safety in this video.
Our collective responsibility as participants in the gene therapy industry is to discover, develop and bring these innovative therapeutics to patients in need with a similar sense of urgency, effectively balanced, of course, with quality and safety.
As gene therapy has made significant progress towards broader clinical and commercial successes, the industry is shifting from treating rare conditions among smaller populations to those that afflict larger populations.
New therapies and cutting-edge technologies have enabled the production of next-generation treatments that improve patient care, simplify administration and increase the availability of life changing medicines.
Process development (PD) is a critical component to the commercialization of viral vector-based therapies. While some gene therapy developers may want to speed through this operation to meet deadlines, doing so can put product quality, safety, and efficiencies at risk.
Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with scaling your viral vector.
Viral vectors are often challenging to produce, especially at the large scales needed to reach the potential of these therapies. The manufacturing process for gene and cell therapies is complex and the current scale-out approach does not support robust industrialization.
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