Newsletter | April 6, 2020

04.06.20 -- COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain

 
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Expert Advice For All Facets Of Managing Your External CMC Partners

More outsourcing needs to translate to better outsourcing — improved efficiencies, productivity, speed, and CDMO relationships. Easier said than done. But no internal function at a biotech or pharma company can do more to accomplishing these improvements than the chemistry, manufacturing, and controls (CMC) group. We’ve collected a series of editorials that feature some frontline examples, and best practices, from a variety of CMC practitioners. Access this free resource.

Featured Editorial
COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain
 
By Christopher Ohms, director, supply chain, Rigel Pharmaceuticals Inc.

To address the current worldwide COVID-19 pandemic more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.

Harmonization Horrors: When Quality System Alignment Goes Wrong
By Allan Marinelli, Quality Validation 360 Inc.

This article is the first in a two-part series explaining how to successfully harmonize disparate quality systems when two companies merge. Here in Part 1, we will focus on what not to do when reconciling two quality systems, providing real-life examples — drawn from the author’s experiences — from each phase of QMS harmonization.

Industry Insights
Understanding The Physical Properties Of An API And Their Effect On Drug Product Performance
Article | By Dr. Peter Poechlauer and Dr. Matthew Jones, Thermo Fisher Scientific

An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

Pharmaceutical Primary Packaging Strategies
Article | By Steve McMahon, Catalent

This article provides an in-depth look at the benefits of developing packaging strategies as early as possible in the drug development process, how primary packaging should be approached to ensure patient compliance, and different forms of packaging that best protect and improve the stability of a product.

Distributed Biobanking: An End-To-End Solution For FFPE Tissue Block Management
Application Note | By Suman Verma, Thermo Fisher Scientific

From a historical perspective, there are millions of FFPE tissue blocks in storage and in use today. Most storage processes work well for small numbers of samples, but they are quickly overrun when thousands of blocks begin to accumulate. A new end-to-end system has been developed and implemented in several locations worldwide to address the issues encountered with FFPE block storage, retrieval, and restocking.

Custom APIs: Aligning Drug Strategy With Partnering Strategy
White Paper | Pfizer CentreOne Contract Manufacturing

With hundreds of potential partners that drug owners can choose from to develop and manufacture custom API, choosing the best partner can be a challenging task. In this white paper we explore the importance of purposefully aligning the overall drug development strategy with a partnering strategy.

6 Reasons You Don’t Use Pharmaceutical Market Research
Article | ISR Reports

If you're using one of these six excuses for ignoring pharma market research, you're failing to understand barriers to success, missing the market’s perspective, and leaving assumptions unvalidated.

Raw Material Variability: The Need For Deeper Process Understanding
Article | GE Healthcare Life Sciences

Principles and methodologies for biopharmaceutical development and manufacturing are well established today. However, the increased molecular diversity, and drive for higher productivity, brings new challenges for process developers. This article shares some insights about how raw material variability is a potential source for process variation. The focus lies on chromatography resins.

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