Newsletter | March 25, 2020

03.25.20 -- 3 Questions Of Risk And Communication In A Time Of Coronavirus

From The Editor
3 Questions Of Risk And Communication In A Time Of Coronavirus
By Louis Garguilo, Chief Editor, Outsourced Pharma

Communication with your service providers may turn out most important in getting through immediate coronavirus-induced supply-chain challenges. Outsourcing may have gotten you into this situation; now it may be the only thing that can get you out. 

Follow The Molecule: One Man’s Tale Of Commercialization And Outsourcing
By Louis Garguilo, Chief Editor, Outsourced Pharma

This is a story of drug and personal development. It demonstrates why our industry deserves respect for its accomplishments, and recognition of the individuals who drive them. And it outlines an interesting strategy for outsourcing drug development and manufacturing.

Featured Editorial
U.S. Sites Play Surprise Starring Role In FDA’s Drug GMP Warning Letter Report
By Barbara Unger, Unger Consulting Inc.

Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

Cell And Gene Therapy Deals: Emerging Trends To Watch
By Lev Gerlovin and Pascale Diesel

The pace of deal making in cell and gene therapy is faster and occurring much earlier in the drug development process compared to what has historically been seen for other innovative therapies. To understand how the landscape is evolving, we reviewed more than 30 deals in the sector and compared them to deals that were executed for monoclonal antibodies (mAbs) between 1999 and 2013.

Industry Insights
Addressing New Chromatography Challenges With Fiber Absorbents
White Paper | By Iwan Roberts, GE Healthcare Life Sciences

An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.

How To Address Process Characterization And Late-Phase Development Of A Monoclonal Antibody
Poster | By Claudia Berdugo-Davis, Ph.D., James Crichton, Benjamin Kester, Kevin Humbard, Yunsong Li, Ph.D., and Victor Vinci, Ph.D., Catalent

Process characterization is an important step in the overall journey of product development. In this poster, scientists propose a step-wise approach for the definition and execution of process characterization for the production of a monoclonal antibody.

How Grünenthal’s Abuse-Deterrent Technology Combats Opioid Epidemic
Case Study | Thermo Fisher Scientific

While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. 

Why Are Lipid Formulations Commonly Used To Enhance Bioavailability?
Webinar | Thermo Fisher Scientific

A discussion on potential mechanisms of increased absorption with lipid formulations, screening tools used during the development of these formulations, scale-up, and industrialization considerations. 

Enviero Progesterone: Green Chemistry Progesterone API
Pfizer CentreOne Contract Manufacturing
Fareva La Vallée Construction
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