Analytics

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

Best Practices for Testing Foreign Particulate Matter in Inhaled Products

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.

Stability Testing Determines Proper Drug Storage Parameters

F. Andreas Toba is Vice President, Intact Pharma Operations, MedInstill Development.

David A. Miller is Manager, Device Performance Engineering, MedInstill Development. 

Bryan R. Campbell is a Doctor of Osteopathic Medicine at Touro University Nevada.

Debashis Sahoo is Executive Vice-President, Regulators & Key Customers, MedInstill Development.

Daniel Py is chairman and CEO, MedInstill Development.

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.

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

Establishing Correlation Between Aerosol and Surface Microbial Populations

Sade Mokuolu, PhD, is group product compliance manager, Watson-Marlow Fluid Technology Group. 

Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.

New Standards Define Single-Use Materials Qualification

Automated Control Concepts has launched Lab Owl bioreactor control system for labs using cell culture and fermentation applications.

Automated Control Concepts Launches New Bioreactor Control System for Data Collection and Analysis

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Natalia Belikova, PhD, is analytical services director at SGS Life Sciences, Lincolnshire, IL.

Hildegard Bruemmer, PhD, is operational laboratory manager at SGS Life Sciences, Germany. 

Forced degradation studies can identify stability problems for drug substance and drug products.

Stepping Up the Pace of Drug Stability Studies

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier. 

The Role of Quality Standards for Biomanufacturing Raw Materials

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

Yueer Shi is group leader, Bristol Myers Squibb, USA, yueer.shi@bms.com

Nicola Hulme is a senior research scientist, Bristol Myers Squibb, UK, nicola.hulme@bms.com

Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, kieran.oconnor@sk.com. (formerly Bristol Myers Squibb)

The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.

Analytical Method Development