SOPs for Biosimilars V 2.0

To establish a validated procedure for determining the oxygen mass transfer rate (kLa) in biosimilar bioreactors to support process optimization, scale-up, and robust control of dissolved oxygen (DO) levels.
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To define the procedure for promptly identifying, recording, assessing, and reporting critical deviations to the Quality Assurance (QA) department in biosimilar manufacturing operations, ensuring compliance with GMP and minimizing product quality risks.
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To define the protocol for establishing and managing continuous culture (chemostat or perfusion) processes in biosimilar manufacturing, enabling consistent product quality and high productivity through steady-state control.
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To establish a standard procedure for the installation, operation, monitoring, and cleaning of cell retention systems such as Alternating Tangential Flow (ATF) and Tangential Flow Filtration (TFF) units used in high-density perfusion-based biosimilar production.
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To define the procedure for evaluating and qualifying new suppliers of culture media and supplements used in biosimilar manufacturing to ensure consistency, performance, and GMP compliance.
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To define the procedure for the qualification, handling, approval, and traceable usage of raw materials in GMP batches used in the biosimilar manufacturing process, ensuring regulatory compliance and product quality.
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To define the procedure for verifying the age of cell cultures before inoculating production-scale or pilot bioreactors in biosimilar manufacturing, ensuring that culture age falls within validated specifications to maintain viability, productivity, and process consistency.
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To establish a structured approach for identifying contamination events and performing root cause analysis (RCA) in biosimilar manufacturing, ensuring implementation of corrective and preventive actions (CAPA) and maintaining GMP compliance.
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To define a standardized approach for handling, investigating, and documenting alarms and alerts generated during culture operations in biosimilar upstream processing. This ensures process continuity, product quality, and GMP compliance.
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To define a structured communication framework for timely coordination among departments such as Production, QA, QC, and Engineering during upstream processing events in biosimilar manufacturing, ensuring consistency, safety, and GMP adherence.
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