Biosimilar White Papers

41. Three Options To Viral Vector Manufacturing Capacity 9/1/2020

    A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.

42. Quality Matters – SEC Analysis For Antibody Aggregates 10/25/2019

    Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

43. Managing Frozen Transport Logistics In The Biopharmaceutical Cold Chain 6/28/2021

    As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become more complex.  This paper provides a framework for making challenging decisions linked to cold chain management before outlining potential solutions that could solve many of the issues surrounding the frozen transfer of biopharmaceuticals.

44. Seed Train Intensification Using High Cell Density Cryopreservation 5/14/2020

    High cell density cryopreservation and the use of a perfused seed train and specially-designed expansion medium can create shorter lead times, reduce plant footprint, increase flexibility and reduce COGs.

45. Integrated Tools For Upstream Process Intensification: Part I 10/27/2019

    Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs), and greater flexibility.

46. 8 mm Needle – Improving Subcutaneous Chronic Drug Delivery 7/21/2020

    Reducing needle length can improve the risk profile of subcutaneous injections and can make injecting viscous formulations easier and quicker.

47. The Science Of Cell Therapy Thawing 4/5/2021

    This guide summarizes the science of thawing following conventional, slow freezing methods. We address how cell thawing has historically developed into the techniques used today, along with the physical and biological implications of key metrics and components, such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.

48. Liposomal And Nanoparticle Technology At Pfizer Melbourne 4/22/2021

    In recent years, liposome technologies have become an important part of the drug delivery armory, with several marketed products now available for use and many more formulations being evaluated in clinical trials.

49. The Role Of CDMOs In Cell And Gene Therapy Process Development 8/5/2020

    This article highlights areas where CDMOs can help companies get started in CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

50. Can mRNA Disrupt The Biopharma Industry? 6/10/2020

    mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.