Discover how we’ve helped our clients achieve their custom cell culture medium and reagent product and process development goals.
Case Studies – Custom Solutions
Customized Cell Culture Media
Challenge:
A preclinical stage regenerative medicine company needed scale-up assistance with customized media they produced at a small scale in their laboratory. They also needed help developing a manufacturing process that would produce a cost-effective end product for their stem cell customer base.
Solution:
QBI proposed a pilot development program to optimize conditions for large-scale manufacturing. The program focused on the following:
- Formulation optimization: QBI scientists reformulated the initial formulation, removing a toxic raw material with no loss in performance or yield on stem cell type.
- Optimization of conditions: Conditions such as mixing times, exposure to light, filling & packing were all optimized for best results.
- QC requirements: Determined the required QC tests and testing schedules. Product performance was determined by cell-based assay.
Results:
A pilot run delivered an optimized formulation for manufacturing commercial-scale batches. Based on the results delivered, we entered into a supply agreement to manufacture commercial-scale lots.
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Custom Cell Culture Media
Challenge:
A Contract Research Organization (CRO) client needed a large single-lot quantity of cell culture medium packaged in 1L and 200L formats. They required the medium to be filled aseptically in non-standard volumes, under GMP conditions. They had no validated manufacturing process.
Solution:
QBI proposed developing a manufacturing process for 200L of aseptic medium with custom fill volumes. Our proposal included:
- Raw Material Sourcing: QBI sourced all critical raw materials of specified grades as per Quality Assurance requirements.
- Source Packaging Materials: We sourced bioprocessing bags to fit the CRO’s bioreactor and accommodate the tight project deadlines.
- Product Storage: We provided temporary product storage until lot release with white-glove delivery at specified dates for use in the CRO’s final product.
Results:
We produced and delivered on time and budget a single lot of medium packaged in 200L bioprocessing bags and 1L bottles. The CRO contracted QBI for continued large-scale batch production of this cell culture medium.
Process Development
Challenge:
A Contract Research Organization (CRO) client needed a reagent in a single lot, large volume, with tight pH range specifications for internal validation purposes. The formulation was developed by mixing three (3) commercial solutions. Technical and financial limitations prevented this method from being scaled to the required volumes.
Solution:
QBI developed a new formulation that could be scaled to large volumes with the following:
- Scratch Weight Formulation Development: QBI sourced all raw materials and validated suppliers.
- Develop Reproducible Method: The reproducible method developed included an in-process pH measurement and adjustment to meet the tight pH range of the final product.
- Documentation: Certificate of Analysis provided, including final pH confirmation from our validated pH measurement method.
Results:
We developed and delivered to the client a custom formulation and manufacturing process. The client contracted QBI for continued production of large-scale batches of the product.
