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

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

Articles

Is there a difference between a specification and a standard?

Singlet Determination Revisited

Anastasiya Zakhvatayeva is laboratory technologist, Process Development Laboratory, IMA Active division.

Maria Grazia De Angelis is associate professor, University of Bologna.

Carlo De Carolis is a graduate student in chemical engineering at University of Bologna.

Pietro Pirera is product manager, IMA Active division.

Alessandro Resta is mechanical designer, Technical Department, IMA Active division.

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity. 

How to Monitor HPMC Concentration Through Conductivity Measurement

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

Amgen to Develop Four Biosimilars in China

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

KBI Biopharma and Heat Biologics Form Manufacturing Pact

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

J&J Gets Complete Response Letter for RA Biologic

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.


Merck & Co.’s Keytruda Gets FDA Approval for Gastric Cancer

New algorithm and functions in Shimadzu’s LabSolutions software enable compliance with data integrity regulations.

Software Adds Data Integrity Functions

The Nano-flow imaging particle analyzer from Fluid Imaging Technologies automatically image nanoparticles for identification.

Particle Analyzer Images Nanoparticles

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

Glythera Licenses Novel Payload Class from Cancer Research UK for ADC Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval. 

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes