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Sam Turner is director of Technology and Development at Capcium.

Naresh Talwar, PhD, is director of Product Development at Capcium.

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Articles

Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.

Novel Formulations and Line Extensions with Soft Capsule Technology

Moritz Perscheid is a pharmaceutical chemist at LGC.

It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.

The Value of Primary Working  Standards in Pharmaceutical Quality Control

Sergio A. Bernal-Chávez, PhD, is research associate at Laboratorio de Investigación y Posgrado en Tecnología Farmacéutica (L-322, Campo 1), Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México.

Sergio Alcalá-Alcalá, PhD, is principal scientist at Laboratorio de Tecnología Farmacéutica, Facultad de Farmacia, Universidad Autónoma del Estado de Morelos, Cuernavaca, Morelos, México.

Doris Cerecedo, PhD, is principal scientist at Laboratorio de Hematobiología, Escuela Nacional de Medicina y Homeopatía, Sección de Estudios de Posgrado, Instituto Politécnico Nacional, Ciudad de México.

, is principal scientist at Laboratorio de Investigación y Posgrado en Tecnología Farmacéutica (L-322, Campo 1), Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México.

The purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.

Thermogelling Matrix-Containing Platelet Lysate-Loaded Elastic Liposomes as a Potential Treatment of Wounds

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.

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.

Peer-Reviewed Research