Dosage Forms

Mark Leykin is senior validation engineer, EMD Millipore.

Andrea Detroy is head of QC packaging materials projects, Medical Devices & Disposables, Roche Diagnostics GmbH, Mannheim, Germany.

Christian Matz is global project manager, Biologics Manufacturing Science and Technology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Ross W. Acucena is regulatory consultant, Provantage Services, EMD Millipore

Articles

Application of single-use technology in a parenteral facility for syringe filling.

Single-Use Technology in Parenteral Fill/Finish

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

Advanced Aseptic Technology Provides Glass-Free Delivery of Injectable Drugs

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

ionHP Biodecontamination Technology for Aseptic Systems

Dalton Pharma completes its $2.5 million expansion in Toronto for sterile and aseptic filling capabilities.

Dalton Pharma Completes Aseptic Filling Capabilities Expansion

PDA works with FDA to create pharmaceutical quality metrics.

Large Industry Cross-Section Contributes to PDA Quality Metrics Recommendations

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Progress in delivery science, manufacturing technologies, and commercialization are playing critical roles in advancing the development of complex parenteral drug formulations for new drug substances having a variety of formulation challenges

Delivering Complex Parenteral Formulations

Aesica expands aseptic capabilities at its Nottingham, UK site with the acquisition of new pre-filled syringes manufacturing equipment.

Aesica Extends Aseptic Facilities to Include Pre-filled Syringes

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Best Practices for Restricted Access Barrier Systems in Aseptic Manufacturing

Susan Schniepp, vice-president of quality and regulatory affairs at Allergy Laboratories and co-chair of the program planning committee for the 2013 PDA/FDA Joint Regulatory Conference, discusses quality systems and related considerations in parenteral drug manufacturing.

Focusing on Quality for Parenteral Drug Manufacturing

New cartridges designed specifically for use on high-speed filling lines increase efficiency.

Parenterals and Injectables