Pharmaceutical Technology Europe-09-01-2005

The European Commission has released its second report to the Council and European Parliament addressing the developments and implications in patent law concerning biotechnology and genetic engineering. The study, which centres on the patentability of inventions relating to stem cells, concluded that those capable of developing into human beings, totipotent stem cells, are to be excluded from patentability on the Directives' grounds of human dignity.

Manufacturers of pharmaceuticals and nutraceuticals can protect their products from moisture and other elements while also enhancing marketability, by adding scent to their packaging. The full line of scented packaging solutions, offered by Süd-chemie, is reported to be ideal for applications that emit an unappealing odour to end users. The packaging can also enhance the marketability of odourless products. The flagship product in the scented solution line is Aroma-Can — a product modelled after the company's desiccant canisters. One-gram canisters will be available in orange and lemon scented variations, and can be inserted at the same high rates of speed as traditional desiccant canisters using standard canister insertion equipment.

The tablet formation of six different carrageenans was analysed by 3D modelling, Heckel analysis, the pressure–time function and energy calculations. It was found that the fibres experienced plastic deformation, which was accompanied by a great deal of elasticity. Measurement of elastic recovery in dependence on maximum relative density and time showed that relaxation is completed a considerable amount of time after tabletting. Shrinking of the fibres occurred in parallel with elastic recovery as a result of the reorganization of the fibre structure. The tabletting behaviour of carrageenans makes them suitable for the soft tabletting of pressure sensitive materials.

IAdvances in pressurized metered-dose inhalers (pMDIs) in terms of formulation capability and the performance of the container closure system enable products to be developed faster and with less technical risk. Despite new delivery devices for new molecules breaking into the pMDI market, pMDIs have the ability to gain regulatory approval significantly faster than a novel device, which could save a company many hundreds of millions of pounds.

Because disposable systems offer benefits that can impact the time for development as well as for the cost of production, the biotech sector is expected to continue to use these technologies ...

Two of the largest companies in the pharma industry are to join forces to supply and distribute 96-well Multi-SPE Extraction Plates. The instruments, which are to be circulated by Millipore, are manufactured by 3M for the purpose of isolating and concentrating low levels of analytes, and function by removing substances that interfere with mass spectrometry signal detection. The devices feature 3M Empore membranes, which produce clean extracts, extend LC-MS/MS column life and decrease instrument downtime.

This article provides an overview of the important factors associated with air handling systems within pharmaceutical and biopharmaceutical facilities. It provides information on the need for these systems, design considerations and advice on the approach to commissioning and qualification.

Planning manufacturing capacity in the pharmaceutical industry is not for the faint-hearted. How can process designers help their clients to overcome some of the problems they face when planning to introduce new capacity? This article sets out to explain some of the techniques that are being employed in the early stages of project development.

Contract manufacturers serving the biopharmaceutical market add capacity in a bet on renewed growth for biomanufacturing.