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By Louis Garguilo, Chief Editor, Outsourced Pharma
You might say John Koleng has been living in the drug development and outsourcing future throughout his decades-long career. That career began in 1996 when as a grad student he helped cofound a CDMO. Today, as a VP at TFF Pharmaceuticals, he's as visionary as ever.
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Our panel of experts raise some interesting conclusions on the relationship between where your CDMO is located and the skilled workers it can hire and maintain. In October 2022, Outsourced Pharma Live's “What’s Driving The Cell & Gene Therapy Outsourcing Capacity Cycle?” panelists discussed the identified macro and micro trends impacting dealmaking at CDMOs. Exclusive data from BioPlan Associates were also presented. Learn what to be on the lookout for as well as how to prepare and take advantage of (another) life cycle in our industry — this time in the cell and gene therapy space.
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By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.
While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the span of oversight has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.
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By Outsourced Pharma
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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Article
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By Isabelle Lambinicio,
Bora Pharmaceuticals
After conducting the legwork of determining the best fit for a CDMO from a capabilities and organizational fit perspective, the next step is working with that vendor on determining costs.
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White Paper
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By Pamela Hamill, Ph.D., Amy Glekas, Ph.D., and Greg Pirozzi, Ph.D.,
MilliporeSigma Biosafety Testing Services
Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
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Poster
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By Joana S. Boura, Radmila Todoric, Jordan Wright, Helen Maunder, Laura J.E. Pearson, Emma Burton, Sara Ferluga, Daniel C. Farley, Kyriacos A. Mitrophanous, Nicholas G. Clarkson, and Hannah J. Stewart,
Oxford Biomedica
A cell line development platform that enables the generation of producer cell lines (PCLs) directly in suspension, in accelerated timelines, has been successfully implemented.
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Article
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Cytiva
In a recent live event with Bioprocess Online, industry experts at various stages of their automation journey discussed their approach to enhancing quality control and data integrity through automated technologies.
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Application Note
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Precision NanoSystems
Learn about the benefits of microfluidics for nanoparticle production over traditional methods as well as scaling nanoparticle production for clinical or industrial use.
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Available On Demand! Throughout the year, chief editor Louis Garguilo brings together industry experts to discuss some of the biggest challenges being faced by both sponsors and CDMOs. Our archived videos can be accessed at any time by registered site users.
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Connect With Outsourced Pharma:
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