Preventing carcinogenic compounds from the pharma supply chain requires coordination.

Detecting Dangerous APIs

Standardized analytical method-transfer kits streamline method transfer and site certification.

Method Transfer Across Global Sites

An LC/MS method detects the carcinogenic impurity NDMA in ranitidine. 

Validated Method of Testing for NDMA in Ranitidine 

Topic

Articles

Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.

Dolomite Microfluidics Partners with MilliporeSigma for Microfluidic Device Kits 

The new powerful, precise, and compact instrument can be retrofitted for point-of-care clinical testing at urgent care facilities, hospitals, or physicians’ offices.

Enzo’s New Portable Microplate Reader Simplifies Laboratory Workflow

The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.

Expansion of APEIRON Biologics and Domainex Partnership will Advance Cancer Drug Discovery

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site. 

Charles River and PathoQuest Establish US Subsidiary for NGS-based Testing Lab 

Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA. 

Samsung Biologics Incorporates Solentim’s Cell Line Development Technology into New R&D Center 

Mogrify’s new technology platform, EpiMOGRIFY, can predict cellular switches important for determining cell identity, cell maintenance, directed differentiation, and cell conversion.

New EpiMOGRIFY Technology Platform Offers Development Support for Allogeneic Cell Therapies

With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.

Novel Single-Cell Whole Genome Amplification Technology Made Commercially Available at ASHG 2020

Joseph Baaklini is the director of the Scientific and Laboratory Services Global Technical Support group for Pall Corporation and leads the Pall Laboratory and Food & Beverage technical division globally.

Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.

Understanding the Critical Role of Integrity Testing in Laboratory Sterility Filtration

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

Analytics

Detecting Dangerous APIs

Method Transfer Across Global Sites

Validated Method of Testing for NDMA in Ranitidine