Biosimilar App Notes & Case Studies

1. Fundamentals Of Size Exclusion Chromatography 5/20/2021

   SEC, also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?

2. Implementing GMP For Early-Phase Development With Cartesian Therapeutics Co-Founder And CEO, Dr. Murat Kalayoglu 8/16/2021

   For nascent cell and gene therapies, navigating the earliest phases of clinical development can prove particularly challenging, as even small issues in manufacturing can spell big problems. In this episode of The Business of Biotech, Dr. Murat Kalayoglu, Co-Founder and CEO of Cartesian Therapeutics, talks about the importance of focusing on GMP manufacturing during Phase I clinical trials to maximize a therapy's potential for success.

3. Accelerating cGMP Production Using Rapid Tech Transfer 4/1/2021

   A partnership between Cytiva and Teva Pharmaceuticals showcases tech transfer success through effective communication, diligent project management, and a wide range of expertise.

4. Capture Of Histidine-Tagged Molecules Using Biacore His Capture Kit 10/21/2021

   Find recommendations for immobilization of histidine-tagged molecules (ligands) by capture to an anti-histidine antibody covalently coupled to a sensor chip surface.

5. Cellvento® 4CHO Fed-batch Medium 4/26/2021

   Different CHO hosts are used routinely to develop such biologics and are combined with several expression system like the dhfr, the UCOE or the glutamine synthetase (GS) system. The platform described in this process guidance was developed to grow a broad range of CHO cells. The production medium supports initial cell growth and production while the highly concentrated, neutral pH feed is added to replenish depleted nutrients required for cellular function and to maintain and extend the production phase in fed-batch mode.

6. Adeno-Associated Virus (AAV) Production Using Microcarriers 6/2/2021

   After comparing adherent, suspension, and microcarrier culture for AAV production, scientists believe microcarrier culture is suitable for production of viral vectors to support gene therapy manufacturing.

7. Increasing mRNA Capabilities, Capacity 9/20/2021

   The growing mRNA vaccine market ― projected to reach $127.3 billion by 2027 ― is fueling high demand for mRNA, which has resulted in a critical need to address mRNA manufacturing bottlenecks.

8. Performance Of Novapure® Plungers For Syringes In Autoinjector Systems 8/4/2021

   When moving from vial systems to pre-filled syringes and autoinjector systems, factors to consider include patient and caregiver needs, drug product requirements, system components, and performance.

9. Quality-by-Design Approach To Enable High-Dose Drug Delivery With Autoinjectors 5/12/2021

   Designing self-injection systems to deliver biological drugs into the subcutaneous space has specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. A quality by design approach can manage all the unavoidable competing requirements and balance performance, robustness, and usability.

10. Developing A Closed Connected Single Use mAb Purification Process 9/28/2020

    This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.