Newsletter | October 9, 2019

10.09.19 -- FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance

Featured Editorial
FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance
By Melissa A. Greenwald, M.D.

Regenerative medicine holds promise, though evidence to back claims about current therapies is underwhelming. The FDA's announcement of the Tissue Reference Group Rapid Inquiry Program returns our attention to the administration's regenerative medicine policy framework.

Using Statistical Tools For Insight Into Recovery Study Data
By Ioanna-Maria Gerostathi, Mohammad Ovais, and Andrew Walsh

This article explores some of the typical issues that may be encountered during recovery studies and explains how the use of statistical tools for assessing recovery data can provide greater insight to guide decisions concerning recovery studies. 

Industry Insights
Introduction To Chromatography For Protein Purification
Article | By Mark Snyder, Ph.D., Bio-Rad Laboratories, Inc.

Whether these proteins are produced by recombinant DNA technology or extracted from sources such as plasma, they need to be highly purified — and the purification process must satisfy a variety of regulations.

3 Steps To Determine Need For A Shipping Lane Qualification
Article | By Travis Hudson, Singota Solutions

Learn how to perform various risk assessments to adequately determine the level of control required to ensure the safe transport of products throughout the pharmaceutical supply chain.

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.

Pharmacokinetic Strategies In CNS Drug Discovery
White Paper | GVK Biosciences

The failure rate for new drugs targeting central nervous system (CNS) diseases is higher than that of other diseases, both preclinically and clinically. This paper discusses some successful pharmacokinetic (PK) approaches employed in the recent past and may help in CNS targeted drug discovery and development efforts.

Achieving Consistency, Reliability, And Accuracy In Bioprocessing
White Paper | Emerson

Consistent and repeatable batch operations are key to productivity in pharmaceutical and biotech processes. This white paper shows the importance of precision and repeatability, and describes how reliable, accurate instrumentation allows automation to support quality and productivity strategies.

Trends And Challenges In Outsourced Oral Solid Dosage Forms
Q&A | Thermo Fisher Scientific

As drug companies have fewer and fewer new compounds entering their R&D pipelines, outsourcing of development and manufacturing activities for oral solid dosage forms and sterile forms is on the rise.

Chasing The Biopharma Market
E-Book | GE Healthcare Life Sciences

From new customer bases and vaccines to biosimilars and antibodies: What are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed?

Eppendorf Complimentary Bioprocess Workshop

Wednesday, October 16, 2019 | La Jolla, CA

Eppendorf invites you to be our guest at a complimentary bioprocess workshop where attendees will benefit as we present and discuss “Implementation of an Affordable and Scalable Manufacturing Strategy for Gene Therapy.” We will also present “A Beginner’s Guide to Bioprocess Modes – Batch, Fed-Batch, and Continuous Processing.”.

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