Manufacturing

Sterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.

It has been a long time coming, but stakeholders in the US are now seriously debating a route to market for cheaper copies of biopharmaceutical drugs. The European Agency for the Evaluation of Medicinal Products (EMEA) has led the way on this issue by publishing clear guidelines on what companies must do to get their versions of drugs such as erythropoietin (EPO), an advanced treatment for anæmia, and similar products approved.

Predicting the flow characteristics of powders during manufacture is especially important for the pharmaceutical engineer. Getting the powder flow wrong can be highly disruptive to plant performance and productivity, particularly where equipment has to be taken off-line and stripped down for cleaning out blockages. The flow behaviour of the individual ingredients may be well known, but as these are blended and reacted their flow properties can change.

The financial return to industry on its investment in academia through licensing and funding of basic research can be similar to that in its own research programmes. A report from the Royal Pharmaceutical Society, UK Drug Delivery Research: The Way Forward in the New Millennium, emphasized the importance of drug delivery research in improving patient outcomes and the opportunities for industry and academia to further explore this area, particularly for newly discovered macromolecular drugs. Unsurprisingly, therefore, industry has become increasingly interested in investing in research performed in academic settings as a complement to its own research. Government is currently exhorting universities to transform their traditional role to institutions that can drive economic development and innovation.

Acambis, FDA, Biogen, Ranbaxy, more

Reflecting strong growth prospects for certain biologic-based drugs, the biotechnology and pharmaceutical majors are proceeding with a strategy of expanding their internal manufacturing networks and partnering with select contract manufacturing organizations (CMOs).

Sartorius has signed a disposables supply agreement with Thermo Fisher.

The Dow Chemical Company has formed an alliance with Colorcon Inc. for the global marketing, sales, technical service, and development and distribution of Dow pharmaceutical excipient products for controlled release applications.

Boston, MA (May 8)-The global biotechnology industry showed several positive signs in 2006, including increases in overall revenues and financing, although the industry as a whole continues to operate at a loss, according to Ernst & Young's annual analysis of the biotechnology industry.

Dublin, OH (May 3)-In preparation for California?s new pedigree legislation, Cardinal Health plans to integrate radio frequency identification (RFID) technology into the operations at its pharmaceutical distribution center in Sacramento by fall 2007.

Hamilton, OH (May 2)-Amylin Ohio LLC, a subsidiary of Amylin Pharmaceuticals, is expanding construction at its manufacturing facility in West Chester, Ohio. The expansion increases the company?s total investment to approximately $400 million.

Geneva, Switzerland (Apr. 27)-A meeting of the World Health Organization and the Committee for Medicinal Products for Human Use's approval of Novartis's new cell culture-derived influenza vaccine offered new hope that sufficient numbers of vaccines could be produced in case of a pandemic.

Devens, MA, Montes Claros, Brazil, and Florence, SC (May 2)-Bristol-Myers Squibb Company, Novo Nordisk A/S, and Roche provided updates to their companies? respective manufacturing expansions.

Rockville, MD (May 1)-The US Food and Drug Administration issued a guidance to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG), a poison.

Mixed-mode chromatography sorbents and custom ligands aim to optimize protein purification.

USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.

There is a tremendous need to enhance delivery of potential therapeutics to the brain for treatment of central nervous system (CNS) disorders. The blood brain barrier (BBB) restricts and controls the exchange of compounds between the CNS and the blood, which requires discovery of new modalities allowing for effective drug delivery to the CNS. Polymer nanotechnology has now become one of the most attractive areas of pharmaceutical research. This review focuses on the current progress in polymeric nanoparticles, where the specific arrangement of the polymeric matter at the nanoscale is utilized to design drug delivery systems that provide safe and efficient transport of CNS drugs across the BBB.

The more experienced contract manufacturers go far beyond superficial process improvements, drawing on their own expertise and resources to improve the service, value and flexibility they offer their clients.

This article discusses a number of factors that may influence the behaviour of conjugated biopharmaceuticals. Optimizing bioconjugation processes may be critical to achieve the desired drug performance.

Key to the success of outsourcing stability studies is the relationship/partnership between the client and CRO. It involves a high degree of trust and mutual support

One of the major concerns with introducing PAT, however, is that the bias towards process engineering may not ultimately lead to complete control of product quality.

...Scotland has a favourable regulatory environment, funding support from its government and some of the most advanced research facilities in the world.

Green chemistry involves redesigning processes so that more of the raw material ends up in the product, rather than as waste...

Irradiation is an established method of sterilization for pharmaceutical products. Radiation sterilization can be achieved with gamma rays, electron beams, and X-rays. Each of these techniques has its advantages and disadvantages. The author describes these methods, the ways to find the correct sterilization doses, and the regulatory and safety concerns about irradation sterilization.

Validating the sterilization process is extremely important in pharmaceutical manufacturing. The authors explore different types of sterilization processes and discuss the importance of finding the worst-case positions of loads or equipment to be sterilized and the worst-case conditions for each sterilization cycle. Biological indicators (BIs) can be used to simulate worst-case scenarios and determine the effectiveness of a particular sterilization process.

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.

A biological indicator (BI) measures the effectiveness of the sterilization process to which it is subjected. Factors such as the test organism, the packaging, the culture material, and the test system all influence a BI's resistance. Carrier material is an often-overlooked factor that also influences BI resistance. The authors examine various solid and liquid carriers, describe their properties, and investigate how they influence BI resistance.

The author clarifies the definition and objectives of overkill sterilization for steam sterilization cycles. Current sterilization practices are reviewed and the validation difficulties associated with the various definitions of overkill sterilization are explored.

Aseptic processing has advanced over the past several decades, yet the pharmaceutical industry is still accepting of its limitations, particularly as it relates to human intervention as a source of contamination. The authors explain the importance of further diminishing the role of operators in aseptic processing and the approaches and technologies needed to achieve that goal.

A roundup of company moves and positioning from the pharmaceutical industry and biotechnology industries and contract service providers.