A Quality Design Approach For Antibody Production

Abstract: Culture media optimization is an inevitable part of upstream process development that is geared to reduce the heterogeneity of numerous different charge variants and modifications during the production of therapeutic monoclonal antibodies (mAbs).  A quality by design (QbD) approach is utilized during expression, especially with media optimization to significantly minimize changes in the glycosylation pattern, charge variants, aggregates, and low-molecular-weight species. QbD approach defines and assures the quality of the product through various development stages. An important step in QbD is the determination of the main quality attributes.

Webinar Highlights:

  • 1) The relationship between the culture media components and the main quality attributes could be successfully utilized for rational optimization of mammalian cell culture media for mAbs production.2) Optimization of cell culture media and conditions based on the Stability Fingerprinting®

    3) Different approaches minimize the heterogeneity of antibodies during their expression. Specially modulating cell culture conditions like media, pH, temperature, dissolved oxygen (dO2) as well as mutations of primary sequence reduces the rate of post-translations modifications on expressed proteins/antibodies.

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Originally Presented Live By:
Indu Javeri is the President of CuriRx and former CEO of Formatech, Head of Manufacturing and Development Abbott Biotech, Associate Director Cambridge NeuroScience.


Friends and Colleagues,

The government has classified the biopharma industry as essential during this trying time. As such, CuriRx is keeping our doors open for business.

We will continue to provide quality contract R&D services in a timely manner and do our part to contribute patient care. At CuriRx, the health and well-being of our employees, clients, and the general public are still our topmost concern and priority. Internally, we are encouraging all staff to adhere to calls for social distancing, asking that they work remotely when possible and maintain a measure of physical distance while working in the lab.

As this pandemic continues to challenge our communities, we have also implemented a number of additional safety measures around the office, including extra hand sanitizer dispensers, “deep cleaning” of all surfaces and doorknobs with heavy duty disinfectants, and encouraging video conferences even internally to discourage the gathering of too many people in one room at a time.

As always, we will continue to monitor the situation globally and adjust our behavior according to federal, state and public health guidelines.

Stay safe and healthy,

CuriRx, Inc.