Topic

Courtney O’Dell is senior scientist at Biopharma Production, Avantor.

Michael Hill was formerly senior research scientist at Avantor.

Lori Fortin is senior research manager at Biopharma Production, Avantor.

Jonathan Fura is manager, research & development at Biopharma Production, Avantor.

William Connors is scientist, research-upstream processing at Biopharma Production, Avantor.

Nandkumar Deorkar is vice-president, research & development, at Biopharma Production, Avantor.

Articles

Researchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.

A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing Process

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.

Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2—Dissolution

Ammar Khawam, PhD, is a senior managing scientist of product development at Parsolex.

Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.

Process Performance as a Means of Quality Management

Yeli Zhang is North America Technical Manager IFF Pharma Solutions, Wilmington, DE.

Elizabeth Tocce is associate application development engineer, Dupont.

Holly Bertrand is Research Investigator IFF Pharma Solutions, Wilmington, DE.

Kevin McIntyre is Laboratory Supervisor, IFF Pharma Solutions, Wilmington, DE.

Fernanda Onofre, Americas Regional Applications Leader, IFF Pharma Solutions, Wilmington, DE.

Amina Faham is Global Director of Applications Development & Innovation; IFF Pharma Solutions, Wilmington, DE.

In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.

Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium Carboxymethylcellulose

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Chuck Pheatt is Professor Emeritus with Emporia State University.

The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.  

Using Tolerance Intervals to Assess Conformance to Requirements

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms. 

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data

Sunday Ndiana-Abasi is an intern pharmacist at the Department of Pharmaceutical Technology and Raw Materials Development in the National Institute for Pharmaceutical Research and Development in Nigeria.

Marlene Ekpo is a youth corp pharmacist and research assistant at the Centre for Nanomedicine and Biophysical Drug Delivery, National Institute for Pharmaceutical Research and Development, and a postgraduate student at the School of International Education, Southern Medical University, Guangzhou, Guangdong, China.

Martins O. Emeje, martinsemeje@yahoo.com, is a professor at the Department of Pharmaceutical Technology and Raw Materials Development and director of the Centre for Nanomedicine and Biophysical Drug Delivery, National Institute for Pharmaceutical Research and Development.

The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.

Evaluating Okra Gum in a Floating Tablet Formulation as a Novel Drug Delivery System

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

Grouping Products and Equipment for a Worst-Case Cleaning Validation Study

Dharmang Pandya is Assistant Professor at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa- 388421, Gujarat, India.

Pushti Gandhi is Research Scholar at Charotar University of Science and Technology, Ramanbhai Patel College of Pharmacy, Department of Pharmaceutics & Pharmaceutical Technology, CHARUSAT Campus, Changa- 388421, Gujarat, India.

Rajesh Parikh is Director at Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar Campus, Nr. Government Polytechnic K-6 Circle, Sector - 26, Gandhinagar-382028, Gujarat, India.

The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.

Peer-Reviewed Research