Newsletter | April 3, 2019

04.03.19 -- CDMOs Respond: Paying For A New Fill Finish Paradigm

  Development And Commercial Manufacturing Outsourcing Models Market Research Report

ISR’s Contract Development and Manufacturing Outsourcing Models report takes an in-depth look at current outsourcing practices among drug innovators to gain insight into the adoption and application of different outsourcing strategies. For this study, we surveyed a group of heavy outsourcers, making them well-qualified to give insight on their experiences using different outsourcing models, including tactical or transactional outsourcing, use of preferred providers, and strategic partnerships. Preview.

From The Editor
CDMOs Respond: Paying For A New Fill Finish Paradigm
By Louis Garguilo, Chief Editor, Outsourced Pharma

As vivaciously as our board members responded to a question regarding their biggest challenges when contracting fill finish services, CDMOs have now reacted in kind. The reactions come from around the world, including four CEOs of CDMOs. One thing both sides agree: They are operating within an encompassing paradigm shift.

Featured Editorial
Analytical Testing Strategies For Clinical And Commercial Operations
By Bikash Chatterjee, president and chief science officer, Pharmatech Associates

A summary of a survey designed to better understand the factors considered when establishing an analytical testing strategy for clinical material release.

Will CDMOs Commit To Fully Transparent Audits?
By Greg Weilersbacher, Eastlake Quality Consulting

The first two articles in this series discussed the physical elements of facility design that sponsors look for in their contract development and manufacturing organizations (CDMOs) and sponsor requirements for dedicating equipment to GMP operations, equipment redundancy, and immediate disclosure of equipment and facility issues. This article presents solutions to improve transparency during sponsor audits of CDMOs.

Industry Insights
Evolution Of Sequencing Technology For Genomics Applications
Article | By Vijay Walia, Fisher Bioservices

Since 2003, after the completion of the Human Genome project, significant progress has been made in sequencing. Read how sequencing technologies have revealed astonishing data over the last ten years for multiple species.

The Unique Needs Of The HPAPI Market: Are You Prepared?
Article | By Vince Ammoscato, Piramal Pharma Solutions

To take advantage of the growing HPAPI market, a company must have the proper controls in place to safely handle these potent compounds and successfully bring its drug to market.

Flow Chemistry: A Scale-Up Solution For Modern API Development And Manufacturing
White Paper | By Peter Pöchlauer, Thermo Fisher Scientific

Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

Model Extraction Studies Examined For Monoclonal Antibody In Prefilled Syringe (PFS)
Case Study | By Aryo A. Nikopour, Nitto Avecia Pharma Services

It’s been more than 30 years since monoclonal antibodies (mAbs) were first licensed for clinical use. But product developers are still inventing novel ways to improve their safety and efficacy.

How To Use QbD Software To Improve An Existing Identification Method
Article | Pfizer CentreOne Contract Manufacturing

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

Speed Biologics To Clinical Trials Faster
E-Book | GE Healthcare Life Sciences

If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.


Just announced! The keynote speaker at the DIA 2019 Global Annual Meeting will be Gary H. Gibbons, M.D., director, NHLBI, NIH. We are very excited to have Dr. Gibbons alongside our other expert speakers in regulatory, industry, patient advocacy, academia, and more. Our program is now live. Start creating your agenda today!

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