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

Articles

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns. 


Phenomenex Opens New Manufacturing Facility

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.


Do You Listen to What Your Data are Telling You?

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding. 

Spectrum Opens Pharmacy Training Center

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Jana Spes is Vice-President, Technical Operations, Apotex, jspes@apotex.com.

Rakesh Singh Chaudhary is scientistâtechnical operations TSS at Apotex Inc. 

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies. 

Continuous Manufacturing: A Generic Industry Perspective

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.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

Kill the Bioburden, Not the Biological Indicator

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

Modernizing Organic and Elemental Impurities Standards

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

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

New Manufacturing Technologies Streamline Laboratory Operations

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

Catalysis, Flow Chemistry Impact API Manufacturing

Steven A. Zdravkovic is a research scientist at PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562. 

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.


Solid-Phase Extraction for the Preparation of Aqueous Sample Matrices for Gas Chromatographic Analysis in Extractable/Leachable Studies

The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines’ OptimaBlend Fluidizing Blender family of horizontal batch mixing systems. 

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes