Meet the Expert: Freek, Quality Control / Validation Scientist
The Quality Control (QC) department performs analytical development, assay qualification, assay validation, testing on raw materials, cell substrates and cell banks. Also, the department is heavily involved in the “in-process” testing as well as testing the final drug substance and drug product. In addition, QC ensures proper inspection of packaging components (e.g. labeling), stability testing, storage, and shipment. Finally, the QC department performs environmental monitoring to ensure the company adheres to all rules and regulations associated with operating clean room manufacturing facilities.
Because of this multitude of tasks, the QC department plays a crucial role (in any company) ensuring consistency, quality, and safety of manufactured drug products. At the heart of the QC department are the standard operating procedures (SOPs) that describe well-designed, well-executed ‘in-process’ and ‘release’ assays to ensure consistency and predictability for manufactured drug products.
Important guidance for the QC department is provided by the “International Council for Harmonization” (ICH). The ICH requirements guide us, amongst others, in the design of product stability studies, relevant thresholds for testing product impurities, qualification and validation methodology. In addition, the guidance provides a flexible approach to pharmaceutical quality based on Good Manufacturing Practice. Translating the ICH guidance to laboratory practices requires a lot of expertise and experience to design proper assays and ensure adherence to set detection limit, robustness, accuracy, precision, and specificity.
At Batavia Biosciences, the Quality Control department is an integral part of the project team during the early research and development (R&D) phases. Thus, the QC experts are involved in the development of the new assays (e.g. ELISA, CEX-HPLC, RP-HPLC, Q-PCR, plaque assays, etc.) which safeguards a smooth and timely transition from an R&D to a GMP environment. Our team is proud that we have a 100% successful track record in ensuring a smooth transition from assay development through qualification up to validation. This in turn allows Batavia Biosciences to move programs forward with the speed biology allows, not being cornered at later stages in the product development owing to surprising data caused by poorly performing assays.
Next to the product-specific tests, rigorous biosafety testing is performed to get the product released. These tests are all designed to ensure microbial safety (e.g. sterility, mycoplasma or endotoxin), the absence of adventitious (viral) agents and residuals like host cell protein or DNA. Here again our proven track record is the best testimony of the in-depth knowledge our QC department brings to the table.
To conclude, at Batavia Biosciences, Quality Control is at the heart of our company culture and as such we are well positioned to support our customers in developing the best strategy for developing the assay required to smoothly transition a biopharmaceutical from bench to clinic.
As a company dedicated to help bringing biopharmaceuticals to the market at higher speed, with reduced costs, and with a higher success rate, Batavia Biosciences has vast experience in developing and validating assays for Quality Control. With our team of experienced QC specialists, we are well equipped to take on any challenge associated with biopharmaceutical testing.