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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 Nazim Kanji,
Quotient Sciences
Explore key considerations to successfully bridge from the initial concept of a pediatric program design and formulation development strategies into later stages of development and through to commercialization.
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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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Q&A
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By Yves Massicotte,
Ropack Pharma Solutions
Learn how outsourcing this key aspect of bringing product to market can benefit your organization and overall supply chain optimization.
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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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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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Lonza
Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.
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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
Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy.
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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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Webinar
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Catalent
Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologic drug product tech transfer.
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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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