Newsletter | May 15, 2019

05.15.19 -- Don't Put "Descartes Before The Horse" When Outsourcing

  Biologic Sterile Injectable Drug Product Manufacturing Market Overview And Outlook

This market research report provides an overview of the current biologic sterile injectable market dynamics as well as what our survey respondents — all outsourcing decision makers — predict the market will look like in 2022. Key statistics include development-stage and marketed product volume, the proportion outsourced, and the number of CMOs required to complete the work. You can purchase the report or download a free preview by clicking here.

From The Editor
Don’t Put “Descartes Before The Horse” When Outsourcing
By Louis Garguilo, Chief Editor, Outsourced Pharma

Robert Ward of Eloxx Pharmaceuticals is on his second tour of duty as chief executive officer of an early-stage biotech. That makes him the perfect “real-life” CEO to react to a recent editorial about a “speculative” CEO who says to her colleagues: “We outsource, therefore we exist.” Ward’s initial thought? “Don’t put Descartes before the horse."

Featured Editorial
What Should You Do After An FDA Inspection?
By Mark Durivage, Quality Systems Compliance LLC

The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals
By Crystal M. Booth, PSC Biotech

This article is the first part of two-part article that will discuss objectionable microorganisms recovered from nonsterile products. In this part, we will explore what constitutes an objectionable microorganism, as well as the regulatory expectations for objectionable microorganisms in nonsterile products.

Industry Insights
Initial Considerations When Formulating Microparticle-Encapsulated Drugs Part 1
Article | By Trae Carroll, Singota Solutions

The emulsion system created when forming microparticles can quickly become complex. Following are critical factors to consider when beginning work with microparticle formulation for a large protein molecule.

ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes
White Paper | By Andrew Chang, Ph.D., Novo Nordisk Quality, Novo Nordisk Inc.

Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC (chemistry, manufacturing, and controls) changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.

Cell-Based Assays In A GMP Environment: Approaches For Clinical And Commercial Stability Studies
Webinar | By Ming Li, Ph.D., and Aryo A. Nikopour, Nitto Avecia Pharma Services

This presentation demonstrates that in vitro, cell-based assays are an indispensable tool to quantify the biological activities, and to support the potency tests, for biotherapeutics.

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.

Quality Metrics: How To Add Value And Meet The FDA's Expectations
Article | Ropack Pharma Solutions

Quality metrics have been widely used in the pharma industry to monitor quality systems and operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

CDMO For All Phases Of The Drug Life Cycle
Piramal Pharma Solutions
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