Manufacturing

Pfizer CentreSource is proceeding with a new plan for the supply of steroids and steroid intermediates through a recently signed pact with two Asian contract manufacturing organizations.

Washington, DC (June 14)-The US Department of Health and Human Services awarded two contracts totaling $132.5 million to Sanofi Pasteur and MedImmune to retrofit their influenza vaccine manufacturing facilities.

The largest study of the genetics behind the world?s most common diseases has been deemed as the start of a new era in medical research.

Brussels (May 30)-The European Federation of Pharmaceutical Industries and Associations (EFPIA) called for the pan-European and industry-wide adoption of 2-D barcode technology to combat the increase in counterfeit drugs in Europe.

WHO is working with vaccine manufacturers to move ahead on plans to create a global stockpile of vaccine for the H5N1 avian influenza virus.

Kvistgard, Denmark (June 4)-Bavarian Nordic received a $1.6-billion contract from the US Department of Health and Human Services to manufacture and deliver 20 million doses of its smallpox vaccine "Imvamune."

Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines, outlining the regulatory pathways for developing and approving these products.

Pharma companies and CMOs build positions in mAbs.

News and Views

Pharmaceutical Technology's Annual Manufacturers' Rankings provides perspectives on revenues, product positioning, R&D spending, pharmaceutical manufacturing activity, and capital projects of the major drug companies.

While some companies float with the tide, others grab market share while business is good.

Exhibitors' products prevent counterfeiting, provide child resistance, protect product quality, and improve packaging-line efficiency.

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 (New York, NY, www.ey.com) annual analysis of the biotechnology industry. Its report, "Beyond Borders 2007," was issued at the Biotechnology Industry Organization's (BIO, www.bio.org) annual conference and exhibition, which was held in Boston May 6–9.

The Active Pharmaceutical Ingredients Committee (APIC) - a sector group of Conseil European des Federations de l'Industrie Chimique (CEFIC) - first voiced the need for EU GMP API legislation in 1993 to help ensure the safety of medicines. In 2000, the International Conference on Harmonisation (ICH) finalized the harmonized API GMP Guideline Q7, which became legal in the US and Japan in 2001. The EU adopted a directive in March 2004 that includes the requirement for APIs in medicines for the EU market to comply with ICH/Q7A. Member States are transposing the directive into their national law: about half of them have completed this process, seven more are well on their way to completion, while seven others are still in earlier stages of adoption.

Fluidized hot melt granulation (FHMG) is an emerging technique combining the advantages of both dry and wet granulation methods, and represents an innovative continuous granulation process capable of mixing and agglomerating excipients and active pharmaceutical ingredients (APIs) to produce uniform blends of particles suitable for use in the manufacture of pharmaceutically elegant solid dosage forms.

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.