Manufacturing

Articles

Drugmakers have many incentives to avoid overfilling their containers, including the scarcity, and correspondingly high cost, of certain cells and ingredients. These concerns highlight the need for techniques that can fill small volumes of product with great accuracy. Many strategies are available to the industry, but which one works best?

Turn Down the Fill Volume

Jerold Martin was the senior vice president of global scientific affairs at Pall Life Sciences and the chairman of the Board and Technology Committee at Bio-Process Systems Alliance.

What have been the key innovations that have shaped current aseptic practices and techniques?

Aseptic challenges: the experts' view

Each sector of the pharma industry is fraught with challenges and weighty regulations; aseptic processes and techniques are no exception.

Aseptic challenges

Closed vial technology has been designed to address the challenges - potential contamination, counterfeiting and process complexity - associated with the aseptic filling of injectable drugs.

Innovations in aseptic technology

Dave Abram is manager of validation and technical services at BioConvergence LLC, 4320 West Zenith Drive, Bloomington, IN 47404, tel. 812.961.1700, fax 812.961.1733.

The author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions.

Current Perspectives on Aseptic Formulations

The author discusses the risks involved with aseptic processing, methods and tools used to identify and control risk, and regulatory guidelines relevant to the risk-management process.

Risk Management for Aseptic Processing

The manufacturing process, which influences a drug's safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

Reducing Supercooling during the Lyophilization of Biologicals

Miron Ludzinski is a senior research scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company.

Madhav Kamat, PhD, RPh, is a senior principal scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08993.

Amol Mungikar, PhD, is a research investigator at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company.

The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.

Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool

Paul Nelles is Vice President Development Services at Vetter Pharma-Fertigung GmbH & Co. KG (Germany).

Why correctly calibrating a drug with its packaging is the key to success.

Successful packaging of aseptically prefilled products

Theodore H. Meltzer is principle of Capitola Consultancy.

Jean-Marc Cappia is vice-president of marketing for fluid management technology at Sartorius Stedim Biotech FMT, Aubagne, France.

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

Manufacturing, Parenterals and Injectables