Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.
As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way.
A guide for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility.
QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed.
Unlike traditional biologic drugs, gene therapy production can involve the manipulation of replication of viruses. Segregation of manufacturing operations involving viruses is a crucial consideration.
Why understanding both the product and every step of the process is crucial in cell and gene therapy production.
PODs provide the environments for the entire upstream and downstream process for a state of the art gene therapy facility.
Flexible and modular facility designs that can be built in a factory, shipped to the site and then rapidly assembled have been recognized and are being addressed by innovative suppliers.
Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.
The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.
If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
Genderless AseptiQuik® L Connectors enable quick and easy sterile connections, in large-volume, high-flow production environments. The largeformat, 3/4" and 1" genderless design simplifies system integration and minimizes the risk of operator error. The connectors’ robust construction provides reliable performance without the need for clamps, fixtures or tube welders. Biopharmaceutical manufacturers benefit from interchangeable 3/4” and 1” flow solutions for full-scale bioprocessing production environments with the quality and market availability they expect from the leader in single-use connection technology.
Genderless AseptiQuik® L Connectors enable quick and easy sterile connections, in large-volume, high-flow production environments. The largeformat, 3/4" and 1" genderless design simplifies system integration and minimizes the risk of operator error.
PODs coupled with LifeAire Systems’ purification technology offers extreme cleanliness and stability of the air in G-CON‘s prefabricated cleanrooms. This is achieved with LifeAire’s proven and patented multi-stage filtration systems built within the POD, eliminating all toxic airborne pathogens within critical space environments on a single pass. LifeAire’s new, transformational and proven technology provides deliverables that exceed GMP metrics that have been recognized as toxic to living cell culture.