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

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

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

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

bluebird bio and apceth Biopharma Enter Manufacturing Agreement

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

Application of QbD and QRM to Analytical Method Validation

Elizabeth Rivera is a technical services manager at the Life Sciences Division of STERIS Corporation.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.