Insights On CONTRACT PHARMA MANUFACTURING
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4 Key Autologous Manufacturing Challenges (Plus How To Solve Them)
5/17/2024
The manufacturing process for autologous therapies is complex and highly customized, requiring well-orchestrated transport, careful planning, and tight control of many discrete and manual processing steps.
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Can’t Afford A Head Of Clinical And CMC? Think Again
5/15/2024
Brian James of Rondaxe, and Joanne Beck of Aerium Therapeutics, consider the basic “org chart” needed to ensure development and manufacturing success at your CDMO.
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How Much Do You Need To Pay Your CDMOs … And When?
5/15/2024
Striking a balance between must-haves, and thus must-pay-fors, with the need for development speed and budgetary constraints, was a serious subject for our outsourcing professionals.
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How Much Can You Actually Rely On Your CDMO?
5/15/2024
At our recent Outsourced Pharma Live, “How Can CMC Keep Up With The Rush To The Clinic?”, our panel of professionals draw the line on how much you can count on your CDMO to do for you, even if you are a virtual biotech.
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“Relentless Transparency” Needed Between CDMO And Biotech Customer
5/15/2024
Vincent Kosewski, VP, Manufacturing & Supply Chain Management, Kala Pharmaceuticals, explains his phrase for how outsourcing communication needs to be handled.
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Speed To Clinic, Cost To Get There, And FDA Expectations
5/15/2024
GSK’s Ben Stevens provides an indepth analysis of the variables regulatory bodies and developers need to balance when considering fast track designations, and the overall rush to get to the clinic.
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When Outsourcing, Get The Right Professionals On Your Internal Team
5/15/2024
In our Outsourced Pharma Live titled “How Can CMC Keep Up With The Rush To The Clinic?”, our speakers all agree: Hire strategically internally for the best results.
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A New Acronym – CBMC? Put “Biology” In CMC? Our Panelists Think Not.
5/15/2024
Chief Editor Louis Garguilo asks our panel if CMC – chemistry, manufacturing, and controls – might be outdated, and whether biology should be added to the acronym.
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Consultants Know: Emerging Biotechs Have Outsourcing “Disconnects”
5/15/2024
Missing an analysis of all the pieces involved in development outsourcing, and a loose connection between the C-suite and reality, can slow down a biotech’s program.
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Speeding Up The Regulatory Side Of Outsourcing
5/15/2024
Benjamin Stevens, Director CMC Policy and Advocacy at GSK provides some intial thoughts on the regulatory aspecs related to moving programs to and through the clinic as quickly as possible.