Newsletter | February 20, 2020

02.20.20 -- The 10 Phases Of An Effective CAPA

  Biologic Drug Product Contract Manufacturer Quality Benchmarking (3rd Edition)

This report provides pharmaceutical companies and contract manufacturers a comprehensive analysis of current outsourcing trends and practices, in addition to a quantitative analysis of CMO service quality across a series of 23 performance attributes specific to outsourced drug product manufacturing. Drug developers can use it to make a more educated purchase of CMO services, and CMOs can use it to understand their strengths and weaknesses. More.

Featured Editorial
The 10 Phases Of An Effective CAPA
By Mark Durivage, Quality Systems Compliance LLC

Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

The 4 Most Important Elements Of A Successful Sponsor-CDMO Relationship
By Christopher Ohms, director, supply chain, Rigel Pharmaceuticals Inc.

When a sponsor contracts with a manufacturing organization to execute a scope of work or a series of tasks on its behalf, the sponsor takes on a level of oversight different from that within its own organization. This article highlights how four understated considerations can play an important role in a successful relationship between sponsor and CMO.

Industry Insights
Container Closure Integrity Testing Of Intravenous Bags
White Paper | By Wen Chen, Ph.D., and Oliver Stauffer, PTI Packaging and Inspection Systems

A noninvasive, nonsubjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.

Blow-Fill-Seal For Biologics: Breaking Through In Pharma Packaging
White Paper | By Bill Hartzel, Weiler Engineering, Inc.

As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs. 

Complex Molecule Development: Early Considerations To Avoid Failing Later
Article | By Andreas Stolle, Ph.D., and Peter Poechlauer, Ph.D., Thermo Fisher Scientific

How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.

Is Your Sterile Injectable Ready For Changes In Raw Materials?
Article | By Lisa Cherry, Ph.D., Pfizer CentreOne Contract Manufacturing

Over the life of a drug changes in raw materials are inevitable. But even a small modification can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.

4 Steps Toward End-To-End Connected Manufacturing
Article | By Avril Vermunt, GE Healthcare Life Sciences

Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.

Revealing Response To A Hypothetical Question About Outsourcing Services
Article | By Kate Hammeke, ISR Reports

If you were in charge of establishing a bioprocessing contract manufacturing business, which service provider attributes would you ensure your company excelled at? Here's how your peers responded.

Cell Growth Performance In Single-Use Bags
White Paper | Sartorius Stedim Biotech

Achieving consistent cell growth is critically important to the biotech industry. To optimize the final drug product output the current industry trends are toward higher cell densities and protein titers.

High-Volume Manufacturing: Essential Points To Consider Before You Scale Up
White Paper | B. Braun OEM Division

To successfully scale to high-volume manufacturing, planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process.

Create Brand Sustainability With Softgel Technology
Article | Thermo Fisher Scientific

Keeping an eye on some emerging trends that are shaping society and the pharmaceutical industry can help you meet those diverse consumer preferences and potentially extend product life cycles.

Build Or Buy: 6 Advantages Of A Customizable GMP Environment
Case Study | Almac Group
An alternative solution to the “build or buy” decision is the use of readily available, prequalified GMP facilities that can be fully tailored to suit individual needs and budgets.
Serialization And Aggregation Of Drug Products
Case Study | Wipotec-OCS

A pharma company found a solution that allows the operator to conveniently assign the units from a lower packaging level to a higher level and, in this way, to set up the hierarchical relationships in the database.

Improving Pharma And Biotech Manufacturing Processes And Production
E-Book | Thermo Scientific Product Inspection

This guide will discuss industry concerns and present an overview of solutions that help pharmaceutical and biotech manufacturers save time, improve processes, protect brand integrity, and ensure safety.

The 7 Essentials For A Successful Cleanroom RFP
Infographic | AES Clean Technology, Inc.

If you follow these seven steps, you will receive better responses to your cleanroom RFP (requests for proposals) and be able to identify differences and minimize risks.

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