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.

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Articles

The Chinese facility was cited for data integrity violations.

Zhejiang Medicine Receives FDA Warning Letter

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.

New Equipment Meets Need for Innovation in Pharma Manufacturing

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

David G. Dolan is senior manager, Occupational, Environmental, and Quality Toxicology at Amgen Inc.

Mohammad Ovais is senior pharmaceutical scientist at Xepa-Soul Pattinson (Malaysia) Sdn. Bhd.

Andrew Walsh, M.S., certified Lean Six Sigma Black Belt, is President of the Center for Pharmaceutical Cleaning Innovation in Hillsborough, NJ. He can be reached at andy.walsh@centerforpharmaceuticalcleaninginnovation.org.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Cleaning Limits—Why the 10-ppm and 0.001-Dose  Criteria Should be Abandoned, Part II

Stability testing programs should provide drug owners the information needed to establish the proper handling, shipping, and shelf-life recommendations for drug products.

Testing Programs Ensure Drug Product Stability and Shelf Life

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

Multiple methods are required for detecting and removing protein impurities.

Protein Impurities Pose Challenges

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

NIST Issues mAb Reference Standard

Nexera-i MTUHPLC and HPLC analysis on a single system

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

EMA Suspends Drugs Due to Flawed Bioequivalence Studies

The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes