Newsletter | February 11, 2020

02.11.20 -- Evaluating New FDA Draft Guidance: Qualification Process For Drug Development Tools

Featured Editorial
Evaluating New FDA Draft Guidance: Qualification Process For Drug Development Tools
By Bikash Chatterjee, chief operating and science officer, Pharmatech Associates

The FDA issued draft guidance on the qualification process for drug development tools (DDTs) in December 2019. The guidance defines DDTs as methods, materials, or measures that have the potential to facilitate drug development — examples include a biomarker used for clinical trial enrichment, a clinical outcome assessment used to evaluate clinical benefit, or an animal model used for efficacy testing of medical countermeasures.

5 Supply Chain Questions Every Drug Company Should Know The Answers To
By Hal Craig, founder, Trout Creek Consulting, LLC

Part 1 of this two-part column raised the point that if you’re not happy with one or more of your suppliers, it may be because you haven’t clearly told them what you want, what your expectations are, and what is important to you. Here in Part 2, we explore five important questions that can serve as a brief checklist to help drug companies both figure out and communicate their expectations to suppliers and understand their suppliers’ expectations.

Industry Insights
Global Air Cargo Trends Reshaping Pharmaceutical Transport
Article | By Dominic Hyde, Pelican BioThermal

As we welcome the new decade and the exciting advances it is expected to unleash, many of the forces that shaped the past decade for transporting pharmaceuticals will continue. Price pressures, alternatives to air freight, and increasing automation are just a few. However, there are emerging trends that make 2020 unique. As we look forward, these are the air cargo trends expected to shape the transport of pharmaceuticals in 2020 and beyond.

Managing Risks With Potent Pharmaceutical Products
Article | By Thomas Ingallinera, Pharmaceutics International

Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

Fermentation Optimization: Using Comparative Statistics To Enhance Large-Scale Process Productivity
Article | By Jonathan M. Glynn, Ph.D., Pfizer CentreOne Contract Manufacturing

Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 108 U/batch.

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.

Novel Uses For Oral Solid Doses Driving Lifecycle Management Strategies
Article | By Anil Kane, Ph.D., Thermo Fisher Scientific

With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.

Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?
White Paper | By Patrick M. Hutchins, Ph.D., TSI Incorporated

Real-time viable particle monitoring instruments have been available for over five years. This white paper intends to describe this technology and how it is used to detect viable particles in real time.

Explore Alternative Analytical Methods To Solve Process Challenges
Case Study | By Shaonly Saha, Grifols Recombinant Protein CDMO Services

Successful and rapid analytical method development plays a key role in ensuring the development of robust processes to produce high-quality products. 

Innovative Packaging For A Two-Component Device Inhaler
Case Study | PTI Packaging and Inspection Systems

WALDNER solves a packaging challenge for a global pharmaceutical company with an ingenious filling and sealing machine.

Optical Rotation And Quality Control
Article | Anton Paar USA

The optically active pharmaceutical and its mirror image are referred to as enantiomers. While they might possess identical physical properties, their physiological properties can differ dramatically. 

Applying Quality Systems Approach To Improve Supply Chain Management
Article | B. Braun OEM Division

This article presents a quality systems technique that is ideal for improving trust between a manufacturer and a supplier, as well as improving the overall quality of medical devices.

Understanding And Delivering Your EU Orphan Drug Launch
E-Book | Almac Group

Although rare diseases are characterized by low prevalence individually, the total number of people affected by rare diseases in the EU is estimated at between 27 and 36 million.

Capture OTC Market Share For Geriatric And Pediatric Patients
Webinar | Thermo Fisher Scientific

This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. 

  BioProcess International US West Conference & Exhibition

Stay at the forefront of bioprocess technology by attending the upcoming BioProcess International US West Conference & Exhibition, held March 9 to 12, 2020, in Santa Clara, California. Starting at $99, the exhibit hall pass provides you access to the largest exhibition on the West Coast, featuring 1,000+ attendees and 80+ exhibitors devoted exclusively to biopharmaceutical manufacturing and production. Learn more and register your pass today.

API Capabilities
XC3 Checkweigher
Mettler-Toledo Product Inspection
Quick To Clinic For Oral Solid Dose
Thermo Fisher Scientific
Allergard 617 Dual Access Small Animal Cage Changing And Transfer Station Purchase Specifications
NuAire, Inc.
Ibex Dedicate
Lonza Pharma & Biotech
Live Webinar: Headspace Gas Ingress Testing As A CCI Test

Presented By Lighthouse Instruments
Tuesday, February 18, 2020, at 10:30 am EST

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