Manufacturing

The authors developed a formulation for effervescent gastroretentive drug delivery techniques using ibuprofen as a model drug. They optimized the formulations by applying full factorial design.

President Obama and HHS eye innovation and countermeasures to protect public health.

There are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.

Since its introduction more than 10 years ago, single-use bioreactor technology has now become an established addition to today's biotechnology manufacturing facility.

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.