Newsletter | November 25, 2019

11.25.19 -- Are Good Manufacturing Practices No Longer Good Enough?

Featured Editorial
Are Good Manufacturing Practices No Longer Good Enough?
By Mark F. Witcher, Ph.D.

Janet Woodcock’s recent comment on the state of pharmaceutical development, “It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?

Understanding The FDA’s KASA Framework
By Bikash Chatterjee, president and chief science officer, Pharmatech Associates
The FDA's Knowledge-aided Assessment & Structured Application framework (KASA) marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed.
Industry Insights
Scale Matters: A Flexible Approach To Demand Uncertainty
Article | By Bruce McCafferty and Mark Santos, Lonza Pharma & Biotech

Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.

What Makes A “Good” Bioprocess?
Article | By Serena Smith, Thermo Fisher Scientific

The development of an optimized bioprocess requires a holistic approach tailored to the specific needs of the product.

Automated Cell Bleed Control In An Intensified SU Rocking Motion Bioreactor
Application Note | By Svea Grieb, Johannes Lemke, Markus Schulze, and Jens Matuszczyk, Sartorius Stedim Biotech

Intensified processing represents a major trend in the biopharma industry because it increases the productivity of Single-Use (SU) facilities, while decreasing the manufacturing footprint. Here's how to optimize the approach.

Rethink Aseptic Filling To Meet Pharma’s Challenging Requirements
White Paper | Singota Solutions

Rethinking aseptic filling from technology to process to service while meeting shifting market demands will help all participants in the pharmaceutical industry, and, ultimately, help the smaller patient populations who need targeted therapies.

Quantitating Binding Similarities In IgG Fcγ Receptor Analysis
Application Note | GE Healthcare Life Sciences

Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.

Innovative, Flexible, And Time-Sensitive Packaging Solutions
Case Study | Thermo Fisher Scientific

Given the rapidly changing landscape of today's trials, if sponsors wish to succeed, they must remain vigilant — attending to every detail of the process. Learn how several sponsors achieved success through these case study examples.

Biogen Employees Receive Critical Documentation In Clean Environments
Case Study | Dassault Systemes Americas

Upon assessment of their paper-based SOP delivery system, facility leaders at Biogen's Cambridge manufacturing plant found their procedures inefficient and costly. Find out how much the company saved by choosing a digital platform.

The Challenges Of Biopharmaceutical Quality
Q&A | Samsung BioLogics

More than ever, the quality functions in biopharma manufacturing are under pressure. That pressure is unlikely to be relieved any time soon due to a global market rife with complex quality standards.

The Path To Confidence At Every Point Of Connection
E-Book | CPC

Single-use technology (SUT) has transformed biopharmaceutical development and manufacturing. While the benefits of SUT in bioprocessing are clear, the pathways to successfully applying SUT continue to rapidly evolve. 

Analytical Support And cGMP Stability Services
Argonaut Manufacturing Services
Meissner Capsule Filters
Meissner Filtration Products
Gibco Media And Feeds Selection Guide
Thermo Fisher Scientific
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