Manufacturing

Single?use solutions, such as bags, tank replacements and aseptic connection devices (ACDs) have revolutionised our industry, providing improved sterility assurance.

There are apparent inconsistencies between the use of these reference materials and the manufacture of the reference solutions that are actually used in the regulated test method.

Life science industry users of single?use devices have legitimate questions about the potential for leachables to impact the quality of their pharmaceutical products.

There are several key advantages that single-use systems offer over conventional stainless steel equipment.

The willingness of the industry to use single-use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production.

The early part of the decade saw a decline in vaccine sales and manufacture, but finally the industry is bouncing back, with Europe particularly well placed to make an impact.

The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.

The advantages of coupling hot melt extrusion technology with online FT-NIR spectroscopy are explained.

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

The author discusses new detection-system technologies that can improve performance and provides key criteria to consider when selecting or upgrading a system for pharmaceutical use.

Several industry experts describe applications in pharmaceutical applications, including on-line total organic carbon analysis, ultra-fast liquid chromatography, rapid microbial testing, and differential scanning calorimetry-Raman Spectroscopy.

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality.

The author describes the development of small-angle X-ray scattering and analyzes its advantages in the characterization of drug-delivery systems and large molecules. This article is part of a special Analytical Technology issue.

Using new co-processing technologies, the authors show that it is possible to formulate an 'all-round' excipient.

The benefits that can be gained by integrating single-use systems into a commercial cell culture facility depend on whether the systems are to be used in an existing or a new facility. It is usually more beneficial to use Single-use systems in a new facility because this offers the opportunity to reduce the requirements for floor space and to reduce or eliminate the need for utilities, such as steam, ventilation, cleaninplace systems, water systems, etc.

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

The authors discuss the approach taken to develop a new calibration approach, its associated protocols, and how it can be used to calculate data.

The authors review and discuss the influence of glycans on the conformation of a representative IgG1 biopharmceutical using H/DX-MS as an analytical tool.

The European Medicines Agency and the US Food and Drug Administration announced their individual regulatory decisions and resulting actions regarding the marketing of GlaxoSmithKline's (London) Avandia (rosiglitazone), a thiazolidinedione used to treat Type 2 diabetes.

Novartis Sells US Enablex Rights; Ricerca Names Chemistry Director; And More.

Amgen (Thousand Oaks, CA) issued a voluntary recall last week of certain lots of Epogen(R) and Procrit(R) (Epoetin alfa) vials.

DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.

Johnson & Johnson (J&J, New Brunswick, NJ) announced last week that it was in "advanced negotiations" for a potential public offer for the Dutch biopharmaceutical company Crucell (Leiden, The Netherlands).

The US Food and Drug Administration recently issued a Warning Letter to Bristol-Myers Squibb (BMS, New York) for violations of current good manufacturing practice at the company's Manati, Puerto Rico, manufacturing facility.

Genzyme Sells Genetics Business; Bausch and Lomb Names Vice-President; and More.

Last week, Lonza (Basel) agreed to support the ongoing development of GlaxoSmithKline?s (GSK, London) biopharmaceutical pipeline by supplying manufacturing capacity for five early-stage monoclonal antibodies.

Bristol-Myers Squibb (New York) has agreed to acquire the biopharmaceutical company ZymoGenetics (Seattle) for an aggregate purchase price of $885 million or $735 million net of cash.

The generic-drug company Actavis (Hafnarfjordur, Iceland) is considering acquiring a 51% stake in the biopharmaceutical company BioPartners Holdings (Barr, Switzerland) from Bioton, a Polish biotechnology company.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the September 2010 edition from Alfa Laval and Gems Sensors and Controls.

The author describes the types and sources of rouge and explains ways to prevent and mitigate this problem.