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

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

Articles

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.

SGS Adds to ICP-MS Capabilities

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

Overcoming Obstacles in Process Analytical Technology

Changes Everything  LCMS8060 triple quadrupole mass spectrometer expands UFMS family

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

Using Spectroscopic and Virtual Sensor PAT in Continuous Solid-Dosage Manufacturing

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

Capsugel Announces Commercial Availability of Modular Automated Sampling Technology

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes