cGMP Biologics Commercial Manufacturing

Our San Diego site operates ISO Class 7 and ISO Class 8 manufacturing spaces, with ISO Class 5 biosafety cabinets (BSCs) for critical operations, such as cell bank filling.

We offer parallel manufacturing campaigns within segregated upstream and downstream suites. By allocating dedicated single-use flow paths and product-dedicated purification columns/resins, we mitigate cross-contamination risks and enable flexible scheduling.

Comprehensive quality oversight spans from raw material inspection and weigh-dispense activities, through in-process monitoring and final bulk drug substance release. Our Quality Management System (QMS) integrates documentation, deviation management, change management, and the analytical controls required for both clinical and commercial regulatory standards.

Fluid contact surfaces – including bioreactor bags and downstream tubing—are single-use. This design eliminates the need for cleaning and sterilization validation (CIP/SIP), significantly reducing turnaround times between batches.

Since each batch uses fresh, disposable components, there is no carryover between production runs, ensuring a multiproduct facility can operate without cross-contamination risk or compromising product quality.

Single-use assemblies and a flexible facility design can be swapped out or reconfigured quickly to accommodate new campaigns or scale adjustments, enabling sponsors to move from clinical pilot-scale batches to larger commercial campaigns in a streamlined manner, typically without requirement for engineering runs.

Harvested Cell Culture Fluid (HCCF) is generated through either depth filtration or centrifugation to remove cells and debris. The clarified fluid is filtered through a 0.2 µm filter, reducing bioburden and preparing it for chromatographic purification.

For antibody products, Protein A chromatography is typically used as the first purification step. Eluted material undergoes a low-pH hold to inactivate potential viral contaminants, aligning with global regulatory expectations.

• Anion Exchange (AEX) Flow-Through —further removes host cell proteins (HCP), DNA, and aggregates.
• Cation Exchange (CEX) Bind/Elute—enhances purity and product-related variants or higher molecular-weight species.

Inline pre-filters and dedicated virus filters provide an additional viral clearance barrier. All process filters must satisfy a post-use integrity test before the resulting material can progress to the next step.

The purified product is concentrated and buffer-exchanged to its final formulation. After a final sterile filtration, the bulk drug substance (BDS) is ready for freezing or direct fill operations.