11.26.19 -- 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).

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).

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.

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.

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.

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.

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.

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

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.

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?

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.

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. 

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

FAREVA

Thermo Fisher Scientific

B. Braun OEM Division

Meissner Filtration Products

Flow Sciences Inc.

ILC Dover

West Pharmaceutical Services, Inc.

Federal Equipment Company

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