Biosimilar App Notes & Case Studies

41. How Collaboration Transformed A Generic Into A Best-In-Class New Drug 10/7/2020

    Learn how a drug developer collaborated to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators.

42. Security Of Supply In Cell And Gene Therapy Manufacturing 9/24/2020

    With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

43. End-To-End Process For Oncolytic Adenovirus Production 3/20/2019

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

44. Cell Therapy Manufacturing Under GMP - How And When To Get Started 5/2/2019

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

45. A Model To Increase Yield In mAb Cell Culture Perfusion At Large Scale 9/28/2020

    As process intensification is adopted into large scale manufacturing, the responsibility of scale-down models to accurately represent the expanded operating space quickly follows. 

46. Practical Tips To Develop A Lentivirus Packaging Cell Line 9/9/2020

    CAR T therapies are expensive, and lentiviral vectors production represents a large portion of these costs. These practical tips guide efficient development of a lentivirus packaging cell line.