There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Articles

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

FDA Sends Warning Letter to Illinois Manufacturer

The innovations-oriented Think Tank combines academic-scientific and technical expertise to use Shimadzu’s expertise to provide even more customer-focused service.

Shimadzu Launches European Innovation Center

Boehringer Ingelheim, 900 Ridgebury Road, Ridgefield, CT 06877, USA

Merck & Co., Inc., Kenilworth, NJ 08550 USA

Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080, USA

Pfizer Inc., Eastern Point Road, Groton, CT 06340, USA

GSK, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2NY, UK

Abbvie, 1 N Waukegan Rd, North Chicago, IL 60064, USA

Janssen Pharmaceutica R&D, a Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

BMS Bristol-Myers Squibb Company, P.O. Box 5400, Princeton, NJ 08543-5400, USA

AstraZeneca, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK

Eli Lilly & Company, Lilly Corporate Center, Indianapolis, IN 46285, USA

A survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.

Risk-Based Predictive Stability–An Industry Perspective

Mohamad J. Altamimi is a forensic analyst, Department ofForensic Evidence and Criminology, UAE, Dubai, Dubai Police HQ,Al Tawar 1.

Paul G. Royall is lecturer in pharmaceutics at the Institute of Pharmaceutical Science, King’s College London, London SE1 9NH, United Kingdom.

Kim Wolff is professor of addiction science at at the Institute of Pharmaceutical Science, King’s College London, London SE1 9NH, United Kingdom.

Gary P. Martin is professor (emeritus) of formulation science at the Institute of Pharmaceutical Science, King’s College London, London SE1 9NH, United Kingdom.

This study investigated the stability of solid lactose stored under high temperature and humidity conditions.

An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress Conditions

Darren Barrington-Light is a marketing specialist for informatics and chromatography software at Thermo Fisher Scientific.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.

Harnessing Advances in Informatics to Ensure Data Integrity

Oskar Gold is Vice President, Key Account Management & Corporate Marketing, at Vetter.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

Insourcing vs Outsourcing: Choosing the Right Strategy

Michael Pfeiffer, PhD is global quality manager at Boehringer Ingelheim Pharma GmbH&Co. KG, Binger StraÃe 173, 55216Ingelheim a. Rh., Germany; Tel.: +49 (0) 6132-777013;michael.pfeiffer@boehringer-ingelheim.com.

This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.

Key Considerations in Outsourced “On-Site” Audits as Part of Supplier Qualification

Monica McDonnell is director strategic business development Europe at Informatica.

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.

The Challenge of IDMP Compliance

The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.

Microsoft and Adents Develop Traceability Solution for Track and Trace

SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes