Newsletter | January 11, 2023

01.11.23 -- A Historic Outlook For 2023
 
From The Editor
A Historic Outlook For 2023
 
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.
Featured Editorial
CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance
 
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.
December 2022: CDMO Opportunities And Threats Report
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.
Industry Insights
Pediatric Dosage Form Development: Program Design And Formulation Development
Article | 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.
Implementing Green Chemistry In Biopharma: Design To Delivery
Article | 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.
How To Reduce Change Orders In Your Product's Tech Transfer
Article | 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.
Considerations When Outsourcing Your Packaging Operations
Q&A | 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.
Outsourcing Highly Potent API: It’s What You Know And Who You Know
Article | 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.
Recent Innovations And Enhancements To Pharmaceutical Spray Drying
Article | 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.
Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy
White Paper | 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. 
CDMO Collaboration: Foundation For Sterile Injectable Product Success
White Paper | 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.
Strategies To Mitigate Common Pitfalls In Early Drug Development
Q&A | Catalent

Two experts discuss the ways companies can address issues with low bioavailability and the benefits of enlisting an experienced drug development partner.
Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies
Webinar | 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.
Solutions
Lab Equipment And Testing Site Matrix
Cambrex
Outsourced Pharma Live
 

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.