Whether you are partnering from the outset of your program or choosing a dedicated finished goods provider, work with a team that will decipher your goals to ensure your program is a success. A manufacturer should aim to understand and achieve your ideal project outcomes via transparent communication and collaboration.
To accommodate revisions to the European Commission’s Annex 1 regulatory framework, many CDMOs are retrofitting existing fill lines to meet updated environmental monitoring standards. When assessing manufacturing partners, consider the impact of working with a CDMO who designed their fill line with Annex 1 specifications as a guide.
As biopharma shortages continue to be a global concern, consider working with an innovative manufacturer to help alleviate challenges. If faced with uncertain demand forecasts, a CDMO that offers modular manufacturing and the ability to shift between continuous and large-scale platforms as needed can help ensure reliable delivery to patients.
We utilize aseptic isolator filling systems with a single-use product path to meet your program needs. We designed our end-to-end service with a patient-centric focus, offering partners convenience as well as cost and time-saving measures.
Our globally integrated drug product and finished goods services offer agile and flexible solutions for clinical to commercial products. End-to-end services designed for patient safety and centricity while offering contracting convenience, cost efficiencies, and time savings.
