Biosimilar App Notes & Case Studies

31. Pluripotent Stem Cell Expansion And Scale-Up 8/5/2020

    Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

32. Single Cell Passaging With NutriStem® hPSC XF On Laminin-521 Without The Need For ROCK Inhibitor 8/13/2021

    Human Pluripotent Stem cells (hPSC) are of great potential for cell therapy and regenerative medicine in many severe diseases. Removing xeno components and using feeder-free cultures is necessary to ensure robust and reproducible colonies during culture.This paper explains how the combination of xeno-free media (i.e. NutriStem® hPSC XF), recombinant protein matrices (i.e. LaminStem™ 521) and recombinant trypsin solutions (i.e. Recombinant Trypsin EDTA Solution,) enables single cell passaging without the addition of ROCK inhibitor, while maintaining cell integrity and characteristics.

33. Efficient Transition Of Human Pluripotent Stem Cell Cultures From Essential 8™ Medium Into NutriStem® hPSC XF Medium On Matrigel® 8/13/2021

    Establishing ideal culture methods has been a known challenge in human pluripotent stem cell (hPSC) research since the late 90s. Today, there are multiple commercially available serum-free formulations for hPSC maintenance, including Essential 8™, mTeSR™, and StemFlex™ culture media. This paper review the suggested method for adapting hPSCs originally cultured in Essential 8 Medium (E8) to NutriStem® hPSC Medium.

34. In-Line Real-Time Monitoring Of CHO Cell Culture Processes 9/16/2021

    Demonstrating the Procellics™ Raman Analyzer with Bio4C® PAT Raman Software for in-line, real-time measurement of TCD, VCD and the concentration of glucose, lactate and ammonium.

35. 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.

36. Efficient Transition Of Human Pluripotent Stem Cell Cultures From StemFlex™ Medium Into NutriStem® hPSC XF Medium On Matrigel® 8/13/2021

    Establishing ideal culture methods has been a known challenge in human pluripotent stem cell (hPSC) research since the late 90s. This paper reviews the suggested method for adapting hPSCs originally cultured in StemFlex™ to NutriStem® hPSC Medium. Read how for this transition, a simple and direct adaptation can be followed with cultures exhibiting similar morphology as well as higher levels of pluripotency when compared to StemFlex™.

37. Executing A Closed Connected Process From Start To Finish 12/22/2020

    This article provides recommendations from the execution of a closed and connected mAb process, from design considerations to scale-up, including the small-scale modeling that directed our manufacturing scale processes.

38. Protein A Resin Reduction Achieved With Process Transfer From Batch To BioSMB 6/7/2021

    Learn how transferring an existing batch chromatography process into a multi-column format and then scaling up that process to a continuous perfusion run resulted in a dramatic reduction in protein A resin requirements.

39. The Importance Of CDMO Capacity For Viral Vectors: A Conversation With Forge’s Dr. Timothy Miller 10/4/2021

    In this episode of The Business of Biotech, Forge Biologics' Dr. Timothy Miller talks about the importance of increasing specialized CDMO capacity for cell and gene therapy applications.

40. Improving The Overall Efficiency Of Cell Line Development 12/6/2021

    With demands for shorter timelines and increasing complexity of modalities you need a modular design framework that can leverage analytical data, unify processes, and transform current workflows.