Newsletter | September 11, 2019

09.11.19 -- Biopharma Leaders Need Lengthier Lists For Outsourcing Competency

  The CMC Function: Best Practices And Optimization

ISR interviewed 15 CMC (chemistry, manufacturing, and controls) professionals at 14 Top 50 pharmaceutical and biotechnology companies, as well as one company outside the Top 50, to better understand the CMC function throughout the preclinical, clinical, and commercialization phases of the product development process. This report details how CMC departments are modeled, challenges faced by CMC professionals, and best practices/forward-thinking perspectives about how the role may evolve over time. More.

From The Editor
Biopharma Leaders Need Lengthier Lists For Outsourcing Competency
By Louis Garguilo, Chief Editor, Outsourced Pharma

Essential at biopharma: comprehensive lists and analyses to ensure all aspects of your outsourcing (and internal activities) are thoroughly considered as you chart your path forward. "Think big, think long, and think detailed.” So says one biopharma professional who's done it successfully for decades.

Featured Editorial
Improving Outsourcing Relationships
By Kate Hammeke, VP of market research, Industry Standard Research (ISR)

ISR research indicates that proactive communication between sponsors and CMOs in three areas will help to improve outsourcing relationships. Data comes from ISR’s Development and Commercial Outsourcing Models market research report.

What Organizational Design Says About Your Commitment To Data Integrity
By Kip Wolf, Tunnell Consulting, @KipWolf

Understanding how to be appropriately staffed, and being prepared to explain any perception of inequity, could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

Industry Insights
Overcoming Bioavailability Challenges In Oral Formulation Development
White Paper | By Sundeep Sethia, Ph.D., Pharmaceutics International

With nearly 90 percent of the developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must be prepared to address this obstacle by applying various approaches to improve an API’s pharmacokinetics. 

Designing In-Vitro Dissolution Test Conditions During Early-Phase Formulation Development
White Paper | By Dinesh M. Morkhade, Sandeep Rana, Vishakh Kharat, and Umesh Barabde, Piramal Pharma Solutions

Deriving in vitro dissolution test conditions represents a challenging area for many organizations progressing through early-stage development. Unfortunately, the stakes here are high. Inappropriate dissolution test conditions during early-phase formulation development may lead to a partial or complete failure of desired bioavailability in vivo.

Five Questions On Extractables And Leachables In Clinical Development Studies
Q&A | By Aryo A. Nikopour, Nitto Avecia Pharma Services

Extractable and leachable (E&L) safety assessments can be some of the most challenging review issues in an FDA application. That is because they require a coordinated effort between review staff from chemistry, manufacturing, controls, and toxicology. When should you begin your E&L studies? Do the FDA and EMA consider them differently? Learn the answers to these questions and more in this Q&A.

Initial Considerations When Formulating Microparticle-Encapsulated Drugs Part 1
Article | By Trae Carroll, Singota Solutions

The emulsion system created when forming microparticles can quickly become complex. Following are critical factors to consider when beginning work with microparticle formulation for a large protein molecule.

How Services Marketers Can Own Their Performance Measures
Article | By Kevin Olson, Industry Standard Research

Service marketers can take control of their marketing performance by implementing credible marketing effectiveness measures and creating their own narrative.

Improved Method For Determination Of Adenovirus Concentration Using Surface Plasmon Resonance
Application Note | GE Healthcare Life Sciences

The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.

Meeting Milestones — And Patient Needs — Through Expedited Delivery Of Phase 1 Materials
Case Study | Thermo Fisher Scientific

To quickly deliver their product to patients in need, Reneo Pharma teamed up with Thermo Fisher Scientific to take advantage of its Quick to Clinic for Oral Solid Dose program.

Enviero Progesterone: Green Chemistry Progesterone API
Pfizer CentreOne Contract Manufacturing
Mammalian Cell Culture: Process R&D Services
Lonza Pharma & Biotech
Contract Development And Manufacturing: A CDMO Beyond Measure
Samsung BioLogics
OnTheGo Services
Thermo Fisher Scientific
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