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

Natalia Markova is principal scientist, MicroCal, Malvern Instruments.

Articles

Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.

Using Microcalorimetry to Accelerate Drug Development

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

Analytical Method Validation Using QbD and QRM

Cherie Schneider is associate research scientist-microbiologist at Pfizer CentreOne.

Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.

Overcoming Low Endotoxin Recovery

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 1

Agilent’s new facility in Folsom, California includes laboratory, order fulfilment, and warehousing space.

Agilent Technologies Opens Technology Center in California

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

New software platforms aim to help manufacturers implement connected technology and use data efficiently.

Using the Internet of Things to Manage Manufacturing Equipment

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

EAG Laboratories Opens Dedicated ICP-MS Lab

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

Idifarma Reports Record Growth

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes