AAV vectors from a CDMO that cares about SMEs
GMP manufacturing of AAV vectors for medicinal human use is a highly regulated process. The production facility needs to be designed for both GMP and biosafety, and certifications from regulatory authorities are required for compliance verification. Setting up the infrastructure from the start and hire of experienced scientists and operators can be a challenge for drug developers as time frames are tight. Not to mention capital investment that may be out of reach, especially for small and medium enterprises, SMEs.
Biovian is a One-Stop-Shop CDMO, which means that the offered AAV vector services span from the laboratory bench to the clinic. The 4000 m2 facilities and processes are EMA certified and FDA inspected. Switching providers at various stages could cause costly delays and risks, so Biovian is licensed for GMP production of both investigational drugs and commercial gene therapy products. Part of the One-Stop-Shop concept of Biovian is to source or produce GMP-grade materials, such as plasmids and cell banks to get you started. We also provide access to the newest production platforms through our partnerships. To complete the service chain, an aseptic filling is provided under the same roof. Full GMP documentation and detailed batch records are provided, and our Qualified Persons are at your service to ensure that products are certified for clinical use before shipping.
Caring for the needs of SMEs
How to secure a production slot? The AAV vector manufacturing capacity at Biovian has more than doubled since the opening of the new state-of-the-art production facility. Forming a partnership with us at an early stage helps us design a production road map for you. Biovian has gained the reputation as a CDMO that provides premium services to small and mid-sized companies - those are at the core of innovation but often find themselves overrun by bigger clients when reserving CDMO resources. We understand that early-stage trials require fast response, a high degree of customization and flexibility in production. Net Promoter Score as high as 72 in client satisfaction speaks for itself.
Flexibility and Scalability
The rapid growth in the development of AAV vector-mediated gene therapy products has increased the need for small to medium-sized batches. Biovian responds to the need through flexible process development or efficient technical transfer, depending on the starting point. At the same time, the importance of scalability can’t be overemphasized. Our processes are built with scale-up in mind to minimize the need for process changes and for studies required to demonstrate equivalence.
To summarise, the main goal of a CDMO is to manufacture AAV vectors efficiently and cost-effectively to support client success. Biovian’s One-Stop-Shop service concept is designed to provide flexibility in all clinical phases. In this way, Biovian supports SMEs as they take their valuable AAV vectors through the development and onto the market.
This text was originally published in the European Biotechnology Magazine Spring 2021.