Wednesday, October 20, 2021 Daily Archives

Recombinant Proteins for Cell and Gene Therapy Research: A Conversation with Shenandoah Biotechnology

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Recombinant proteins such as growth factors and cytokines are essential for cell therapy, gene therapy and regenerative medicine research, development and manufacturing. These proteins are critical in the production of desired cell types and subsequent differentiation of cells, to deliver the desired effect. Founded 15 years ago, Shenandoah Biotechnology applies a proprietary method of folding and purifying recombinant proteins from both bacterial and mammalian systems to enable cost-effective, large-scale production of Cell Therapy Grade proteins to support these groundbreaking treatments.…

October 20, 2021

Enhancement of Tablet Coating Using an Innovative Functional Excipient

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During formulation of solid dosage forms, film coating is used to improve the appearance and stability of tablets, make them easier to swallow, mask the taste, modify or sustain release, protect the drug from the harsh gastric environment, protect from moisture and/or oxidation and, as a result, to improve the stability and overall therapeutic effect of the final drug product. Depending on the individual needs, a polymer with appropriate properties is chosen during formulation development to serve as film-coating matrix.…

October 20, 2021

Cytiva Strategy for Host Cell Protein Control

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A critical aspect of therapeutic development and manufacture is host cell protein (HCP) detection, quantitation, and removal from drug substances, to ensure efficacy and prevent immunogenicity. It is important to mitigate risk by challenging your assay for each new molecule and selecting the most suitable kit. Cytiva offers a range of solutions to support scientists and developers in creating an effective strategy for HCP control. Read more about our strategy for HCP control.

October 20, 2021

Boehringer’s adalimumab becomes first interchangeable mAb biosimilar

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The US FDA has approved Boehringer Ingelheim’s Cyltezo as the first biosimilar interchangeable with AbbVie’s blockbuster monoclonal antibody Humira (adalimumab). While biosimilars have offered cheaper versions of biological drugs in the US for six years, the issue of interchangeability has muddied the waters. An interchangeable biosimilar is one that can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. Interchangeability is an additional standard beyond the requirement for biosimilarity and thus…

October 20, 2021

Terumo and BioCentriq to drive automated CGT manufacturing

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BioCentriq’s laboratories will be equipped with Terumo’s technologies to accelerate the adoption of automated production for cell and gene therapies. Apheresis services firm Terumo Blood and Cell Technologies and cell and gene therapy contract development manufacturing organization (CDMO) BioCentriq have entered a strategic collaboration to bring cell and gene therapies (CGT) to individuals more quickly and cheaper. “This agreement will expand customer reach by introducing early-stage CGT researchers and developers to the benefits of manufacturing automation and demonstrating how to…

October 20, 2021