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 Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline. 

Seattle Genetics Acquires Pharma Manufacturing Facility from BMS

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.


Congress Passes FDA User-Fee Reauthorization Bill

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker. 

Targeting Drug Delivery with ADCs

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.

Targeting Drug Delivery with ADCs

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.

Just the Pharma Facts, Please

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier. 

The Role of Quality Standards for Biomanufacturing Raw Materials

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 author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.


Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two

Jordan Collins is manager of statistical support at Apotex, Inc.

Naheed Sayeed-Desta is manager of process validation at Apotex, Inc.

Chetan Doshi is vice-president of product development at Apotex, Inc. 

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

A Continuous Improvement Metric for Pharmaceutical Manufacturing

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

A sampling of new laboratory equipment showcases streamlined operations.


New Lab Instruments Tackle Workflow Challenges

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.


Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes