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

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

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.

Mass Spec Sheds New Light on Biologics Drug Development

Silvia Rocchi is a junior researcher in the E&L and Process Troubleshooting Lab, Protein Chemistry Dept. PADB P, Merck Serono.

Gabriella Angiuoni is QC Market & LC M Unit HeadâGlobal Manufacturing & Supply, Merck Serono.

Irene Cecchini is lab manager in the E&L and Process Troubleshooting Lab, Protein Chemistry Dept. PADB P, Merck Serono.

Daniele Mastroianni is a junior researcher in the E&L and Process Troubleshooting Lab, Protein Chemistry Dept. PADB P, Merck Serono

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

Evaluating E&L Studies for Single-Use Systems

Jizhou Wang is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

Neeru Takiar is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

Huyi Zhang is chemist at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

David J. Skanchy is a senior supervisory regulatory review officer, at the Division of Life-Cycle API, Office of New Drug Product, Office of Pharmaceutical Quality, Center of Drug Research and Evaluation Center, Food and Drug Administration.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

Characterization of Small-Molecule Drug Substances in Type II DMFs Supporting ANDAs

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.

This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.

Establishing Blend Uniformity Acceptance Criteria for Oral Solid-Dosage Forms

The RA802 Pharmaceutical Analyzer from Renishaw is a compact benchtop Raman imaging system that enables users to formulate tablets by speeding up the analysis of tablet composition and structure.

Pharmaceutical Analyzer Uses Focus Tracking Technology

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

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes