SOPs for Biosimilars V 2.0

To establish the procedure for monitoring key metabolites such as glucose, lactate, and ammonia in bioreactor operations for biosimilar manufacturing, ensuring optimal cell growth and product yield.
Click to read the full article.

To define the procedure for online calibration of bioreactor sensors including pH, Dissolved Oxygen (DO), and temperature sensors to ensure accuracy and regulatory compliance during biosimilar production.
Click to read the full article.

To define the procedure for monitoring partial pressure of carbon dioxide (pCO₂) and oxygen (pO₂) during bioreactor operations for biosimilar production, using inline sensors and off-line validation to ensure cell culture health and productivity.
Click to read the full article.

To provide standardized guidelines for detecting and correcting in-process pH drift during bioreactor operations in biosimilar manufacturing to maintain culture conditions and ensure product consistency.
Click to read the full article.

To define the procedure for assessing cell viability in bioreactor cultures using the Trypan Blue exclusion method and flow cytometry, ensuring accurate evaluation of culture health during biosimilar production.
Click to read the full article.

To establish a standardized procedure for determining the optimal time to harvest bioreactor cultures during biosimilar production, based on defined critical process parameters and quality attributes.
Click to read the full article.

To define the procedure for centrifuging harvested culture broth from bioreactor operations during biosimilar manufacturing, with the aim of separating biomass and collecting clarified supernatant for downstream processing.
Click to read the full article.

To describe the standardized procedure for primary clarification of harvested cell culture broth using depth filtration systems to remove cell debris and insoluble impurities prior to downstream purification in biosimilar manufacturing.
Click to read the full article.

To outline the procedure for executing Tangential Flow Filtration (TFF) to concentrate and perform buffer exchange on clarified cell culture supernatant as part of upstream/downstream transition in biosimilar production.
Click to read the full article.

To establish a systematic approach for conducting hold time studies in harvest tanks used during biosimilar production. This ensures harvested material maintains stability, sterility, and identity during defined storage periods prior to downstream processing.
Click to read the full article.