Newsletter | March 26, 2020

03.26.20 -- Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is "Yes"

 
Featured Editorial
Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes”
 
By Mike Karhoff and Mark Karhoff, Ten Count Consulting, LLC

Imagine the FDA showing up at your headquarters or distribution center for an audit. Your team is ready for the gauntlet of questions and is prepared to show proof through procedures, data, and action. Then, the auditor starts to ask questions about the U.S. Drug Supply Chain Security Act: “Show us how you offer and share your T3 data with downstream trading partners.” You hold your breath and gulp.

How To Facilitate Great Virtual Meetings During A Pandemic (Or Any Other Time)
 
By Amanda McFarland and James Vesper, ValSource

Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, but now there is a public health imperative, with a large percentage of people working from home. If you are facilitating a risk assessment, a root cause investigation, or something similar, you may need to do a “virtual facilitation” with team members and subject matter experts who are scattered around the world.

Industry Insights
Strategies To Address The Viral Vector Manufacturing Shortage
White Paper | By Florence Vicaire, GE, Joe Makowiecki, GE, and Carol Houts, Germfree

Accelerating the production of your viral vector-based therapy requires you to understand the strategies available to address the viral vector manufacturing shortage as well as selecting the most cost-effective solution for advancing your therapeutic.

Approaching Tablet Formulation Step-By-Step To Avoid Risks
White Paper | By Jonathan Gaik, Natoli Engineering Company, Inc.

All formulators need a methodology that gives them reliable and useful information to identify problems before tablet manufacturing begins.

Providing Solutions At Fair Value: A Spray Drying Case Study
Article | By Frederic Baudry and James Faust, FAREVA

Pharmaceutical companies need CDMO partners that provide solutions at fair value. This CMO has a long history of investing in new technologies with innovators to help their customers achieve their goals, and one recent example is the construction of a new Hastelloy spray-drying unit.

Growing With A Flexible, Collaborative CDMO
Article | By Kim Berger and Paul Magreta, Grifols Recombinant Protein CDMO Services

Choosing a CDMO that is agile, innovative, and exhibits a willingness to invest in new equipment, infrastructure, and services will allow the innovator company and the CDMO to grow together.

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.

Quality By Design: A Holistic Approach To Drug Development
Article | By Anil Kane, Ph.D., Kaspar van den Dries, Ph.D., and Douglas Rufino, Thermo Fisher Scientific

While quality by design (QbD) evolves from good practices to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?

Insight From An Expert: A Chemist’s Secrets To Efficient API Scale-Up
Q&A | By Evan Boswell, Pfizer CentreOne Contract Manufacturing

The more efficient your API synthesis, the lower your cost of goods. The author shares his tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

Comparative TOC Rinse-Up Study Of Pharmaceutical Tubing
Application Note | Meissner Filtration Products

Total organic carbon (TOC) content provides a measure of the cleanliness of single-use materials and components considered for use in pharmaceutical manufacturing processes. In this technical bulletin, the results of a rinse-up study to measure the TOC from four different tubing types is presented. The silicone tubings were each rinsed with deionized (DI) water, which was then sampled and analyzed offline to determine the TOC content from each.

Implications Of Inaccurate Forecasting On Biologics Manufacturing
Article | Thermo Fisher Scientific

Inaccurate demand forecasts can have significant implications for companies developing biologics. And it is increasingly difficult to locate capacity to respond to demand changes.

Excipients And SAXS: The Detection Of Structural Aging
Article | Anton Paar USA

A solution to obtain structural information quickly for effective quality control of pharmaceuticals during production or to study ageing effects and other properties.

Can You Afford Not To Outsource Buffer Preparation?
White Paper | Thermo Fisher Scientific

The decision whether or not to outsource buffer preparation is not clear-cut, but it does provide an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

Solutions
Endress+Hauser Service Portfolio
Endress+Hauser, Inc.
Temperature-Controlled Portable And Reusable Medical Transporter
Pelican BioThermal
Industrial Equipment Auctions And Liquidations
Federal Equipment Company
SmartDose
West Pharmaceutical Services, Inc.
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