Protein Services
QC & Batch Release
Select our batch release services, including analytical studies and QP oversight, to ensure compliance with relevant laws, Marketing Authorization (MA) requirements and cGMP guidelines.
Every cGMP batch we manufacture is tested by QC and released according to the product specifications before releasing that batch to our customers.
Rely on our extensive expertise and experience to ensure that the clinical batches, drug substance, or drug product manufactured by us are safe for their intended use. We will deliver a final GMP compliance certificate and batch release in line with our mutually agreed Quality Agreement, and the Dossier will be available.
Comparability studies
Products that have undergone any changes in the original manufacturing process are subject to additional comparability studies to ensure that no changes have been made impacting quality, safety, and efficacy. To support these requirements, we gather quality data before and after the modifications and perform a comparison by analyzing all the available information to confirm that the changes have not adversely affected the physicochemical or biological attributes of the final product.
Stability studies
Drug substance product intermediates (if applicable) and Drug products are subject to stability studies, which allows us to assess sensitivity to factors that may impact the activity, safety, and quality of the product. Prior to performing stability studies, we prepare a stability protocol reflecting the activities and conditions used for study execution under long-term, accelerated and stress conditions.
Fill & Finish
Our solution-driven approach to supporting our customers throughout their biologics journey ensures that all Fill & Finish activities are managed in-house and according to the specifications on format, fill volume and final formulation as defined by our customer.
With you all the way…
together, making advanced biologics, and tomorrow’s life-transforming therapies.
We deliver unparalleled end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for Drug Substances and Drug Products, from pre-clinical to clinical development and commercial phases.
We support our customers wherever they are on their journey, from early-stage development to commercialization. We are passionate, precise, and always close, together, making advanced biologics and tomorrow’s life-transforming therapies.
Pre-Clinical
Phase I
Phase II
Phase III
Commercial
