Drug Development

James D. Colandene, PhD, is manager, Biopharmaceutical Product Sciences, GlaxoSmithKline.

Douglas P. Nesta, PhD, is director, Biopharmaceutical Product Sciences, GlaxoSmithKline.

Kashappa Goud Desai, PhD, is investigator, Biopharmaceutical Product Sciences, GlaxoSmithKline, kashappa-goud.x.desai@gsk.com

Richard A. Lewis is statistics lead, GMS TEC Shared Services, at GlaxoSmithKline.

Articles

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches

Axel Wehrmann is manager, customer service, SGS Life Sciences.

Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.


Clean, Disinfect, and Validate

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

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.

Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough Therapies

Edward Godek is manager of process and technical operations at Glatt Air Techniques, NJ, info.gat@glatt.com.

Chris O’Callaghan is senior product manager at Innopharma Technology, Dublin, Ireland, ocallaghanc@innopharmalabs.com.

Ian Jones, PhD, is founder and CEO of Innopharma Technology and Innopharma College of Applied Sciences, Dublin

Piyush Patel, is formulation technologies manager at Colorcon, PA, ppatel@colorcon.com.

Process analytical technology, based on monitoring particle size distribution and tracking coating thickness measurements in real time, can be used to predict the dissolution of polymer-coated multiparticulates.

Predicting Multiparticulate Dissolution in Real Time for Modified- and Extended- Release Formulations

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

EU and US Pledge to Recognize Each Other’s GMP Inspections

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

Overcoming Obstacles in Process Analytical Technology

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

FDA Warns India API Manufacturer Over Contamination Issues

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

Using Spectroscopic and Virtual Sensor PAT in Continuous Solid-Dosage Manufacturing

GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.

Process and Scaling