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Cell and Gene Therapy, Industrial Impact

Biosimilars in the United States 2023–2027

January 31, 2023

The first biosimilar approved under the abbreviated pathway established by the Biologics Price Competition and Innovation Act launched in the U.S. in 2015.

Spotlight

AllCells, LLC

Founded in 1998, AllCells is a biotechnology company dedicated to providing global researchers and biomanufacturing organizations with a dependable supply of biologically relevant, high quality primary cells that enable drug discovery, development, and manufacturing of cell therapies. Leveraging its expertise in hematology and immunology cell isolations, combined with on-site whole blood and bone marrow tissue collection operations, AllCells maintains direct access to a large repository of diverse donor profiles that can be further screened and qualified for biomedical applications. Utilizing its contiguous cell processing facilities, freshly collected tissue is immediately processed into purified cell types with unparalleled quality consistency. This optimal work-flow provides for the highest viability, purity, and cell count available. Fresh or cryopreserved cells are shipped worldwide, or fresh cells can be immediately utilized in fee-for-service cell-based assays, AllCellutions.

OTHER WHITEPAPERS

Gene and cell therapy analytical and development methods

whitePaper | April 20, 2023

In the three decades that have passed since the approval of the first gene therapy in 1990, these revolutionary medicines have changed the lives of patients all over the world1.

Internal Co-ordination Group for Biotechnology

whitePaper | October 19, 2022

The Organisation for Economic Co-operation and Development and its member countries have been addressing issues related to biotechnology since 1982.

A Cornerstone in the Supply Chain of Cell-based Therapies

whitePaper | February 15, 2023

The diverse therapeutic attributes of mesenchymal stromal cells (MSCs) lend to their rapid development as cellular therapeutics. These unique attributes include potent immu nomodulatory properties [1,2], the potential to differentiate into multiple cell lineages.

WHO considerations on Regulatory Convergence of Cell and Gene Therapy Products

whitePaper | December 16, 2021

Use of cells, tissues, and gene therapy products for the treatment of diseases or 72 physiological conditions has become of wide interest due to their potential to address serious 73 unmet medical needs.

Multi-Attribute Methods for Biopharmaceutical Analysis

whitePaper | December 5, 2022

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

GMP Grade PMSF and Protease Inhibitors

whitePaper | February 23, 2023

Phenylmethylsulfonyl fluoride, better known as PMSF, is a small molecule serine protease inhibitor used to prevent unwanted proteolysis.