June 26th 2025
Prokaryotics will gain worldwide rights to develop, manufacture, and commercialize NAB741, a non-bioactive polymyxin designed to increase permeability of the outer membrane of Gram-negative bacteria.
Characterization of the Performance of Bin Blenders Part 1 of 3: Methodology
May 2nd 2004In this series of articles, bin blender performance is comprehensively reviewed using both free-flowing and cohesive mixtures. In part 1, an introduction to tools and techniques is presented, followed by an examination of parameter effects, mixing mechanisms, and the effects of cohesion on mixing.
21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current Rule
May 1st 2004FDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.
Analysis of Environmental Microbiology Data from Cleanroom Samples
May 1st 2004Current microbiological methods cannot measure microbial contamination at the levels that engineers and regulators seek to establish for aseptic processing cleanrooms. New approaches for assessing data and establishing alert and action levels are advocated, and an example of one analytical tool is considered.
Selecting Lactose for a Capsule-Based Dry Powder Inhaler
April 1st 2004Dry powder inhalers are a well-accepted dosage form for pulmonary drug delivery and a wide variety are either currently available or in development. This article examines a premetered, capsule-based multidose inhaler for which different qualities of a-lactose monohydrate were screened.
Development of PVA Copolymer Capsules
April 1st 2004The bioavailability of some insoluble drugs is enhanced when they are dissolved in the solubilizing agent macrogol 400, although conventional hard capsules cannot tolerate the agent. This article investigates a PVA copolymer, which has been developed by the authors, examining its properties and its suitability as a material in capsule formulations.
Quality Systems for the 21st Century: Process Analytical Technology
March 1st 2004Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process efficiency and quality. This article discusses the implementation of PAT systems into production environments, its impact on quality assurance and the necessity of an integrated approach. Options for implementing PAT are also presented.
Certificates of Test - What are the European GMP Requirements?
March 1st 2004This article examines European differences in GMP requirements for the acceptance of Certificates of Tests. The authors look at how pharmaceutical manufacturers can address the issues and suggest a US-compatible framework for GMPs that could be incorporated into EU requirements.
Targeted Cationic Liposomes: Technologies and Developments
February 1st 2004Cationic liposomes are widely used in gene therapy as a safe alternative to highly immunogenic viral vectors. Attachment of a tissue-specific ligand to the surface of the liposomes can increase specificity and reduce undesired transfection. Targeted liposomes can be categorized as either immunoliposomes or ligand-targeted liposomes. The author provides a brief review of tumour-specific and liver-targeted cationic liposomes and strategies for the development of liposome?ligand complexes.
Changes in US Policy: What Generic Pharmaceutical Companies Need to Know
February 1st 2004In this article the authors examine a number of significant amendments to US policy regarding generic pharmaceuticals. These important changes could have a major impact not only on the US pharmaceutical market, but also globally. The US Food and Drug Administration (FDA) implemented new regulations, effective from 19 August 2003, that promise to benefit generic pharmaceutical companies in several ways. Significantly, they seek to prevent multiple 30-month stays and resolve much of the uncertainty regarding which patents may properly be listed in FDA's Orange Book.1,2
Cleaning Validation Practices: Using a One-Pot Processor
February 1st 2004This article describes the use of a one-pot processor for the cleaning and cleaning validation of two drug compounds - water-soluble theophylline and water-insoluble mebendazole. Both substances were produced using wet granulation and microwave drying, after which the processor was cleaned using its clean-in-place (CIP) system. Swab samples were taken from areas considered critical during processing and analysed for remains of active ingredient. It was concluded from the results that the processor's CIP system is capable of removing both moieties to a level well within accepted regulations.
ISO Standard for Primary Packaging Materials
January 1st 2004Based on a German initiative, an international standard on quality management systems for the primary packaging materials of medicinal products is discussed in this article. This new directive will help to standardize the production of primary packaging materials by defining global requirements.
Validating Computerized Systems
December 1st 2003When implementing computerized systems, it is important that both purchasers and vendors ensure that each stage of the process (from planning through operation to modifying) is properly validated. This article looks at some of the issues that arise when switching from traditional document-based procedures, and at the benefits that computerized systems can bring.
The Hidden Economic of Calibration Management
December 1st 2003The importance of calibrating instruments used in manufacturing processes is well known, particularly for highly regulated industries such as pharmaceutical production. This article discusses software applications used to support calibration management, and the potential economic gain to be had by replacing a standalone software application with a capable enterprise system.
Improving Protein Capture for Transgenic Drug Processing
November 2nd 2003One of the greatest challenges facing biopharmaceutical manufacturers has been the primary recovery of recombinant materials from transgenic sources. As an alternative to existing methods, vibrating membrane technology, which is widely used in food and beverage processing, recently has been adapted to biopharmaceutical applications involving transgenic biosolutions.
The Need for Effective Document Change Management in the Pharmaceutical Industry
November 1st 2003With the advent of regulations such as 21 CFR Part 11 and the introduction of the electronic common technical document, it is becoming increasingly important to be able to enhance and fully utilize data management systems. Document change management is a vital tool in the construction and organization of valuable information, and can play a key role in the all-important process of getting a product to market.