Newsletter | November 26, 2019

11.26.19 -- Process Characterization: The Foundation For Validation

Featured Editorial
Process Characterization: The Foundation For Validation
By Mark Durivage, Quality Systems Compliance LLC

Process characterization is the foundation for process validation activities. Too often, validation activities fail due to the lack of process characterization using sound statistical and scientific methods, including design of experiments (DOE).

Clinical Logistics Service Provider Use By Category
In Q3, 2019, ISR asked outsourcers of clinical logistics about the types of service providers they use and prefer for clinical logistics. The data shows the majority of outsourcers use integrated clinical trial service providers (79 percent), specialty couriers (71 percent), and package delivery companies’ healthcare offerings (63 percent).
Industry Insights
Five Questions On Extractables And Leachables In Clinical Development
Q&A | By Aryo A. Nikopour, Nitto Avecia Pharma Services

Extractables and leachables (E&L) safety assessments are among the most challenging review issues in an FDA application, because they require a coordinated effort among chemistry, manufacturing, and controls (CMC) and toxicology review staff. Here's guidance on five common questions.

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.

Ultralow Temperature Freezers: A Guide To Proper Use And Preventive Maintenance
Article | By Adam Christensen, NuAire, Inc.

The following criteria will help a lab manager train users and maintenance staff on protocols to keep the ultralow temperature (ULT) freezer running optimally and reliably for cell preservation.

Answering Today’s Pharma Dilemma Of Build Or Buy
Article | By Charles Christy, Lonza Pharma & Biotech

A new business and operating model may address the build or buy dilemma, offering an innovative and agile way to manage demand uncertainty and reduce the risks associated with early investment decisions.

A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
White Paper | By Andrew Goodsall, GE Healthcare Life Sciences

An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply in order to meet the needs of patients.

Guidance For Lab Washer Cleaning In Life Sciences
White Paper | By Jeff Phillips, Alconox, Inc.

The principal concern for any scientist or technician working in the laboratory is that glassware, instruments, and equipment be free of interfering residues.

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.

Automated Endotoxin Testing Reduces Errors And Review Time
Case Study | By Scott Kaszuba, Pfizer

Pharmaceutical manufacturers are embracing automation and robotics, which are already mainstays of other manufacturing fields; but can automation and robotics be brought into the QC lab as well?

Manage Risks In Development And Manufacture Of Potent Pharma Products
Case Study | Pharmaceutics International

Given the variety of potent drugs in development, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multiuse facility, is an effective strategy.

Understanding Quality Agreements Between You And Your Service Provider
Article | Ropack Pharma Solutions

An effective quality agreement communicates the responsibilities of each party in a clear, concise manner, allowing the reader to quickly and accurately determine to whom a specific responsibility is assigned. 

Challenges, Risks, And Strategies For Biologic Substance Manufacturing
Article | Thermo Fisher Scientific

From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production.

Pharmaceutical And API Capabilities
Bulk Process Liquids For Bioproduction
Thermo Fisher Scientific
Single-Use Standard Bags
B. Braun OEM Division
Capsule Filters
Meissner Filtration Products
Hybrid Isolator Series
Flow Sciences Inc.
Air-Purifying Respirators, Which Remove Contaminants From Air
ILC Dover
Daikyo Crystal Zenith
West Pharmaceutical Services, Inc.
IMA High-Speed Capsule Checkweighers, Model Precisa 120
Federal Equipment Company
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