Newsletter | January 9, 2020

01.09.20 -- Formal Quality By Design Documentation: When Should You Begin?

Featured Editorial
When Should Formal Quality By Design Documentation Begin?
By Kevin Wall, Cincero Consulting

When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities? 

Best Practices In Preclinical Development Of Cell Therapy Products
By Nathan Manley and Katy Spink, Dark Horse Consulting Group, Inc.

Given the diverse and often multifunctional nature of cell-based therapeutics, it is not possible to define a one-size-fits-all preclinical program for cell therapy.

Industry Insights
Complete Quality Control With Rotational Viscometry Applications
Article | By Neimar Da Silva, Anton Paar USA

To ensure a consistent flow of material during production, Anton Paar has designed the ViscoQC 300, a multipoint viscosity measurement tool for achieving outstanding results in viscosity determination.

10 Considerations For Balance Stability
Article | By Cameron Faulconer, Flow Sciences Inc.

Stability of your weighing balance is paramount when it comes to collecting reliable data. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success.

Avoid The Fallout From Incompatibility Between Your API And Its Formulation
Article | By Matthew Jones, Thermo Fisher Scientific

It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.

Developing A New Biologic Drug: Regulatory Challenges And Considerations
Article | By Parrish Galliher and Brian Hubbard, GE Healthcare Life Sciences

The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market there are many regulatory milestones and hurdles.

Keeping Pace With Increasing Biopharmaceutical Manufacturing Demand
Article | By Michelle Calhoun, AbbVie

Today’s biologics pipeline is healthy, but forecasts indicate growth so robust the industry risks being ill-equipped to meet demand. Will contract manufacturers rise to the demand challenge?

Is Your Partner Prepared For Your Scale-Up Challenges?
White Paper | By Devan Patel, Pharmaceutics International

Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization; it is critical you find a partner that can help you overcome the challenges.

Risk Mitigation Of Parenteral Packaging With Container Closure Integrity
White Paper | By Oliver Stauffer, PTI Packaging and Inspection Systems

Parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a threat of bacterial ingress.

Using Pneumatic Tech To Build High-Performance Liquid Dispensing Systems
White Paper | By Craig Correia, Festo Corporation

This white paper explores the basics of designing a pressurized dispensing system — including how to manage flow, pressure, and other control variables to optimize your throughput in these critical applications.

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; however, it provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

Leverage The Internet Of Things Within The Laboratory
White Paper | Dassault Systemes Americas

As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms. 


Learn how to optimize your clinical operation knowledge and stay ahead of the game at this year’s Pharma Packaging and Labeling East Coast! This conference will cover all aspects of the packaging and labeling value chain, delivering actionable insights on the very latest regulatory requirements and how to implement them into your packaging and labeling chain with maximum efficiency and minimal cost.

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