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

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Articles

The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.

PQRI Case Study (3): Facility Biocontainment and Inactivation

Elham Blouet is Pharmaceutical Project & Development Manager, Pharmaceuticals & Cosmetics BU, at Roquette.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

Carbohydrates For Injection

Dr Jerry Sellors is IR business manager, analytical sciences and laboratory services, at PerkinElmer.

Paul Smith is EMEAI laboratory compliance productivity specialist at Agilent Technologies UK Ltd, 610 Wharefedale Road, IQ Winnersh, Wokingham, Berkshire RG41 5TP, United Kingdom, paul_smith@agilent.com

By providing an information "fingerprint", infrared red spectroscopy is a useful tool for identifying counterfeit pharmaceuticals. The authors identify best practices for ensuring compliance.

FT-IR Identification: the Expertise Required To Ensure Compliance

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

Highly Potent; Highly Challenging?

A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.

Addressing Ways to Improve Supply-Chain Security: A Perspective from Pfizer

The authors provide an overview of methods for the quantitative determination of genotoxic impurities (GTIs) in active pharmaceutical ingredients.

The Determination and Control of Genotoxic Impurities in APIs

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

API Purification

The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.

Sample Preparation for Quantitative Metal Impurity Testing

We try to use previous experience to develop the optimal granulation process for each new ingredient, but we sometimes get it wrong. Many times, we?ve taken materials from the granulator only to find that they exhibit poor flow and insufficient density. How can we easily determine the end point of a given granulation process?

Finding the End of the Granulation Process

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes