Newsletter | October 29, 2019

10.29.19 -- An Introduction To Sampling Plans

Featured Editorial
An Introduction To Sampling Plans
By Mark Durivage, Quality Systems Compliance LLC

Sampling plans are used extensively throughout organizations regulated by the FDA. Most organizations have a statistical procedure that specifies a certain acceptable quality level (AQL) based on risk. (If not, they should!) However, most individuals just follow the requirements of the procedure without fully comprehending how sampling plans actually work.

5 Essential Factors For A Successful Biopharma Product Launch
By Christian Seiffert, Peter Rosenorn, and Sej Brar, L.E.K. Consulting

Rapid changes in the biopharma industry are making it increasingly difficult to launch new products successfully. Especially challenging are novel treatment modalities such as gene and cell therapies, increased use of biomarkers, rare diseases with patients that are hard to identify, diagnose, and access, and expanded requirements to demonstrate economic value.

Industry Insights
Is Your Quality Agreement Fit-For-Purpose?
Article | By Melanie Ziehm, AbbVie

Customers choosing to partner with a trusted CDMO for drug development and manufacture can benefit from an established quality policy addressing management responsibilities, risk management, documentation, change management, CAPA, and process performance and product quality. Leveraging the expertise of a CDMO to assure product safety is a proven approach to product realization.

Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients
Article | By Sanjay Konagurthu, Ph.D., and Tom Reynolds, Thermo Fisher Scientific

Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of formulations, and increase overall speed to market.

Securing Bioprocess Film Supply
Article | GE Healthcare Life Sciences

Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.

Elemental Impurities: Steering Clear Of The Big Four
Article | Anton Paar USA

With new regulations having established a need for the testing of certain elements, correct sample preparation is crucial.

Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing
White Paper | Weiler Engineering, Inc.

Blow-fill-seal (BFS) technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

Top 3 Development Principles For Advanced Biopharmaceutical Tubing: Part 1
White Paper | Meissner Filtration Products

Tubing is one of the earliest components in the pharmaceutical industry to be associated with single-use technology (SUT). The development principles in this paper ensure active risk mitigation and cleaner materials in single-use tubing applications.

Flexsafe 2D And 3D Predesigned Solutions For Storage And Shipping
White Paper | Sartorius Stedim Biotech

The growth of single-use in cGMP production requires enhanced assurance of supply and product performance. Innovative bioprocessing bag technology is meeting these challenges at every process step and application of biomanufacture.

Understanding Sensitivity Principles For Industrial Metal Detectors
White Paper | Mettler-Toledo Product Inspection

This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in contaminants detected.

Life Science Leader Magazine

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.