Microbial Batch Release, Supporting Analytical Studies and Services
Utilize our procedures to gather quality data and perform comparative analysis to ensure every cGMP batch manufactured by us is QC tested and released according to product specifications.
With you on your biologics journey...
Why microbial batch release?
Qualified Persons (QP) are responsible for ensuring that each product batch is manufactured according to the relevant laws, Marketing Authorization (MA) requirements, and compliance with cGMP guidelines.
3P´s batch release, supporting analytical studies and services
Products that have changed in the original manufacturing process are subject to additional comparability studies, ensuring that no changes have been made impacting quality, safety, and efficacy. To support these requirements, our experts gather quality data before and after the modifications and perform a comparative analysis of all available information to confirm that any changes have no adverse effects on the physicochemical or biological attributes of the final product.
Drug Substance, product intermediates (if applicable) and Drug Products are subject to stability studies, allowing us to assess sensitivity to factors that may impact the product’s activity, safety, and quality. Before performing stability studies, we prepare a stability protocol reflecting the actions and conditions used for study execution under long term, accelerated and stress conditions.
Fill and finish
Our solution-driven approach to support you throughout your biologics journey ensures that all Fill and Finish activities are managed in-house according to the specifications on format, fill volume and final formulation as defined.
Every cGMP batch manufactured by us is tested by QC and released according to product specifications before release.
What we will deliver
We ensure all clinical batches, Drug Substance or Drug Product manufactured are safe for intended use by delivering a final GMP compliance certificate and batch release in line with the mutually agreed Quality Agreement and Dossier.