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Written by expert: Caroline, Sr. Scientist Quality Control

The Quality Control (QC) department performs analytical development, assay qualification, assay validation, testing on raw materials, cell substrates, virus seeds and cell banks. The department is also heavily involved in the in-process testing as well as testing the final drug substance and drug product. QC ensures proper inspection of packaging components (e.g. labeling), stability testing, storage, and shipment. Finally, the QC department performs environmental monitoring. This ensures adherence 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 to ensure consistency, quality, and safety of manufactured drug products. At the heart of the QC department are the standard operating procedures (SOPs). SOPs describe well-designed, well-executed in-process and release assays to ensure consistency and predictability for manufactured drug products.

The International Council for Harmonization (ICH) provides important guidance for the QC department. The ICH requirements guide 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 (GMP). Translating the ICH guidance to laboratory practices requires a lot of expertise and experience. This expertise is used to design proper assays and ensure adherence to set detection limit, robustness, accuracy, precision, and specificity.

Quality Control at Batavia Biosciences

At Batavia Biosciences, the Quality Control department is an integral part of the project team during the early development phases. Thus, the QC experts are involved in the development of new assays, such as ELISA, HPLC, Q-PCR, WB and infectivity assays. Their involvement safeguards a smooth and timely transition from an R&D to a GMP environment. We are proud of our very 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. We are not cornered at later stages in the product development because of surprising data caused by poorly performing assays.

Next to the product-specific tests, rigorous biosafety testing is performed for product release according to quality stanards like Ph.Eur. and USP. These tests are all designed to ensure:

  • Microbial safety, such as sterility, mycoplasma or endotoxin
  • The absence of adventitious (viral) agents
  • The absence of residuals, such as host cell protein or DNA.

Here again, our proven track record is the best testimony of the in-depth knowledge of our QC department. To conclude, at Batavia Biosciences, Quality Control is at the heart of our company culture. They are well positioned to support our customers in developing the best analytical strategy. This in turn enables smooth transition of the biopharmaceutical from bench to clinic.

We are dedicated to help bring 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.