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Articles by Bill Shingleton
06.16.22 -- Can USP, NIST, & NIIMBL Conquer The Biggest AAV Quality Challenge?
Article | By Bill Shingleton, Cytiva For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.
05.12.22 -- Your New EU IDMP Implementation Strategy
By Amy Williams, Iperion – a Deloitte business Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.
03.09.22 -- 6 Tips To Ensure Your NDA/BLA Is Ready For FDA Review
By Michael Cooper, Pharmatech Associates When preparing a marketing authorization application for an NDA or a biologics license application (BLA), one aspect that is easily overlooked by small startups and mature multiproduct drug sponsors alike is verification that all commitments made to the FDA have been completed and that evidence of this has been submitted to the agency. While success has been seen in animal models, solid tumors have proved a vexing challenge for CAR T-cell therapies.
09.16.21 -- The Potential Of Ion Channel-Based Therapeutics
Newsletter | September 16, 2021 By Erin Harris, editor in chief, Cell & Gene Jørgen Drejer, founder and chief scientific officer of Saniona, brought me up to speed on the biotech’s targeted treatments for rare diseases, specifically in neurology, as well as the potential of ion channel-based therapeutics.
06.16.21 -- A Maverick Gene Therapy Manufacturing Strategy
By Matthew Pillar, Editor, BioProcess Online As Sio Gene Therapies looks beyond its current GM1 gangliosidosis and Tay-Sachs/Sandhoff disease toward much more prevalant Parkinson's Disease, why would it consider migrating away from a hybrid in-house/CDMO manufacturing model to a fully insourced one? CEO Pavan Cheruvu, M.D. explains the company’s rationale.
06.01.21 -- Navigating The Next Decade In Gene Therapy: 6 Key Factors
Article | By Preeti Phanse, Mark Smith, Ph.D., Jordan Cobia, Hailey Mauro, Jeff Hou, Ph.D., and Matt Zustiak, Ph.D., Thermo Fisher Scientific Built to deliver high-volume performance, these single-use bioreactors address the proliferation of new biologics, rapid shifts in annual volumetric requirements, and improvements in cell culture strategies.
Overcoming Cell Therapy Supply Chain Challenges
By Bill Shingleton, Cell and Gene Therapy Biology Director, Cytiva Patient cells are the foundations for cell and gene therapies, products that are increasing in quantity and in their diverse treatment applications. However, cell and gene therapy supply chains introduce specific challenges that differ from those associated with biologics.
Overcoming Cell Therapy Supply Chain Challenges
By Bill Shingleton, Cell and Gene Therapy Biology Director, Cytiva Patient cells are the foundations for cell and gene therapies, products that are increasing in quantity and in their diverse treatment applications. However, cell and gene therapy supply chains introduce specific challenges that differ from those associated with biologics.
Overcoming Cell Therapy Supply Chain Challenges
By Bill Shingleton, Cell and Gene Therapy Biology Director, Cytiva Patient cells are the foundations for cell and gene therapies, products that are increasing in quantity and in their diverse treatment applications. However, cell and gene therapy supply chains introduce specific challenges that differ from those associated with biologics.
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