Newsletter | November 6, 2019

11.06.19 -- Do The Math: "Reshoring" Adds Up For Biopharma Manufacturing


The BioProcessing Asia Conference was created to advance the contribution of bioprocessing sciences, products, and medical interventions to the region. This e-book provides an illustration of cutting-edge presentations: from the sustainability of biosimilars, to the regulatory climate in Asia, the challenges facing the international bioprocessing community, and the latest technologies for viral vector/vaccine production. Some of the articles you’ll find within the e-book are:

Download the full e-book here: BioProcessing Asia Conference In Review

From The Editor
Do The Math: “Reshoring” Adds Up For Biopharma Manufacturing
By Louis Garguilo, Chief Editor, Outsourced Pharma

“Our mission is to bring back five million manufacturing jobs. That would balance the goods trade deficit in the U.S.,” says Harry Moser, founder of the Reshoring Initiative. “That deficit is about $800 billion per year. To make that amount of product would take about five million people — a 40% increase in US manufacturing.” Pharma, says Moser, should play a role. 

Featured Editorial
Facilitating Data Integrity Through Risk-Based Confirmation Of Performance
By James Vesper, Ph.D., director, Learning Solutions, ValSource

We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?

Analysis: FDA’s Draft Guidance On Premarket Combination Products Review
By Caitlin Bancroft, regulatory affairs, Pharmatech Associates

The new EU draft guidance Guideline on the quality requirements for drug-device combinations and U.S. draft guidance Principles of Premarket Pathways for Combination Products are the latest attempts by each body to adequately regulate combination products. In this two-part series we examine the two guidances in detail, starting with the U.S. guidance.

Industry Insights
How The Integration Of CDMO And CRO Services Benefits Everyone
Article | By Justin J. Kim and Kenneth McMahon, Samsung BioLogics

Through the integration of CDMO services with CRO analytical testing services, biologics makers will be able to deliver high-quality products faster than ever before, with greater flexibility and no dependence on external service providers.

How To Adapt Your Existing Biomanufacturing Process To Maximize Production
Article | By Patrick Guertin and Yasser Kehail, GE Healthcare Life Sciences

Achieving “smarter,” more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry.

Why Early Investment In A Scalable Manufacturing Process Is Critical
Article | By Enrico Corona and Jonathan Sutch, Thermo Fisher Scientific

The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30 percent of compounds successfully transition from Phase 2 to Phase 3.

US Clinical Labels 101: Steps To Ensure Accuracy
Article | Ropack Pharma Solutions

Determining a drug candidate’s probability of commercial success is a most significant phase in the drug development process. There is no room for error.

Rethinking Aseptic Filling: Innovations 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.

Highly Potent Oral Solid Dosage Forms
Pfizer CentreOne Contract Manufacturing
Life Science Training Courses
CRO Oversight Post ICH GCP E6 (R2) Addendum
Writing Effective 483 And Warning Letter Responses
Implementing A Robust Change Control Program: Key Elements For Process And Documentation Compliance

Nov. 6, 2019 | 1:00 PM EST

Measuring CAPA Effectiveness: Critical Tips In Getting The Right CAPA And Showing It Works
Nov. 12, 2019 | 1:00 PM EST
21 CFR Part 11: Understanding The ERES Regulation For Compliance Success
Nov. 13, 2019 | 1:00 PM EST
Essentials Of Disinfectant Efficacy Testing: Ensuring Microbial Control

Nov. 14, 2019 | 1:00 PM EST

Preparing eCTD Submissions: A Step-By-Step Guide
Nov. 19, 2019 | 1:00 PM EST
Electronic Data Integrity In A GxP Environment: Managing The Data Life Cycle For Compliance

Nov. 20. 2019 | 1:00 PM EST

Establishing Appropriate Quality Metrics
Nov. 21, 2019 | 1:00 PM EST
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