Analytics

Articles

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.

Analytical products for improved bio/pharmaceutical development.

Analytical Technologies for Bio/Pharmaceutical Development

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

Camfil APC Expands Laboratory for Testing Dust Collection Systems

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

Analysis of Raw Materials

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.

Laboratory Equipment and Instruments