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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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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 Girish Basavaraju, Ph.D., and Manasa Jayavibhava,
Syngene International Ltd.
Applying a green strategy in drug development can reduce the number of synthetic conversions, shorten the linear synthetic route, and maximize the atom economy.
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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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Article
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By Mark Shepanski and Jeff Clement,
PCI Pharma Services
Robotic sterile fill/finish platforms drive speed to the clinic for both early- and late-phase clinical trials, as well as commercial supply, while also providing an elevated degree of sterility assurance.
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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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Article
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ISR Reports
Discover challenges for drug makers who may want to produce higher potency APIs but have built their manufacturing systems around broad-spectrum medications that don’t require high-containment facilities.
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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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Article
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Thermo Fisher Scientific
With roughly 90% of all drugs failing to make it through clinical trials, accelerating the first step of getting to the clinic with a new mAb candidate is crucial.
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White Paper
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Pfizer CentreOne
Explore how a small or midsize biotech or pharma company developing sterile injectables can benefit from the experience and assistance provided by a CDMO.
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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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Q&A
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Catalent
Two experts discuss the ways companies can address issues with low bioavailability and the benefits of enlisting an experienced drug development partner.
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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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