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Articles by Kyle Zingaro
09.15.22 -- Qualifying Replenishment Working Cell Banks
Have you heard of ? Check it out today for access to candid interviews with top-tier executives on how they do business.
01.18.22 -- Top Regulatory Perspectives For CGT Development
Newsletter | January 18, 2022 By Jiwen Zhang, Ph.D., Renovacor, Inc. The need for standards not only lies in the identification and development of standards, but also in implementation. By Erin Harris, editor in chief, Cell & Gene Carisma Therapeutics' Dr. Debora Barton and Michael Klichinsky, Ph.D., discuss the company's Phase 1 first-in-human study of adenovirally transduced anti-HER2 CAR macrophages in subjects with HER2 overexpressing solid tumors.
12.16.21 -- AI-Driven Drug Discovery: The Latest Market Research
By Nitin Chitmalwar, Transparency Market Research The deployment of AI-driven drug discovery in areas such as oncology, neurology, and cardiology reduces gaps in R&D for improved drug manufacturing processes and further helps in targeted manufacturing of drugs. These technologies are rapidly attracting pharma and biotech companies, CROs, and academics and research institutions.
12.06.21 -- Can Real-World Evidence Transform Healthcare? Recent FDA Activities Indicate Yes
By Stacy Cline Amin, Morrison & Foerster Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.
11.11.21 -- How Single-Cell Multi-Omics Will Accelerate CGT Development
Article | By Joe Cintavey and Meghan Meeuwissen, W.L. Gore & Associates As the biologics market continues to grow, drug manufacturers are looking for packaging solutions that maintain integrity during processing and freezing, are easy to scale up to larger volumes, and remain robust throughout the temperature-controlled supply chain. Why are bags better than many other container choices?
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.
08.10.21 -- The Next Decade In Gene Therapy Innovation
Article | By Kyle Zingaro, Ph.D., Thermo Fisher Scientific The expectation — just as it is with biologics — is that the process is the product. However, cell and gene therapy products have unique features that must be considered during process validation.
03.15.21 -- A Differentiated Approach To Allogeneic Cell Therapy Manufacturing
Newsletter | March 15, 2021 By Matthew Pillar, editor, BioProcess Online Celyad Oncology’s CEO, Filippo Petti, digs in on differentiating his company’s approach to developing and manufacturing allogeneic cell therapies for several oncology indications, including the company's technology platform and scale-up strategies in Celyad’s Belgium-based clinical manufacturing facility.
02.18.21 -- 7 Rules For Properly Interpreting Control Charts
By Mark Durivage, Quality Systems Compliance LLC It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. Article | By George Siu, Samsung Biologics The future of biopharma manufacturing will be shaped by how we collect and use process data.
02.16.21 -- Inside BioCardia's Investigational CardiAMP Cell Therapy For Heart Failure
Newsletter | February 16, 2021 Greetings Cell & Gene readers, Just recently, I caught up with Peter Altman, Ph.D., CEO at BioCardia, to learn more about the company’s CardiAMP Heart Failure Trial and its best possible outcomes for patients. Here’s what Altman had to say. Dendritic cell (DC)-based therapies have emerged as an exciting avenue of cell-based therapy.
12.03.20 -- Advancing The State Of Aseptic Processing: Let's Get Serious
By Phil DeSantis It seems pitiful that, for whatever reason, industry has failed to universally adopt more effective technologies to control contamination to result in safer sterile drugs. On the other hand, the regulators must share substantial blame because of their historically lukewarm acceptance of emerging and even established advanced technologies.
Challenges to Process Validation for Viral Vectors
Process validation is essential for ensuring robust, reliable processes that can produce high-quality viral vector products. Many challenges remain in implementing effective process validation strategies for these highly complex biomolecules. The Process is the Product Owing to the complexity of viral vector products, which comprise multiple proteins and nucleic acids, it is not possible to directly compare batches of the final drug product in the same manner used for conventional biologics.
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