Dosage Forms

Biopharmaceutical company Lipoxen PLC (London, UK) has developed a Hepatitis E vaccine using its novel vaccine delivery technology "ImuXen," which the company claims to be easy to manufacture. According to the company, the proprietary liposomal formulation method delivers vaccine materials to the immune system in a manner designed to emulate the response of a natural encounter with the infection agent.

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing.

Last week, the Generic Pharmaceutical Association (GPhA Arlington, VA) praised a proposal by the Senate Agricultural Appropriations Subcommittee that, if approved, would provide $10 million in additional funding for the US Food and Drug Administration?s (Rockville, MD) Office of Generic Drugs.

The US Food and Drug Administration (Rockville, MD) approved the first generic versions of "Zocor" (simvastatin), the anticholesterol drug by Merck & Co., Inc. (Whitehouse Station, NJ).

Pfizer, Inc. (New York, NY) reports the United Kingdom's Court of Appeal has upheld the exclusivity of the main patent covering atorvastatin, the active ingredient in "Lipitor."

Drug development opportunities, specification development, and new vaccine technologies were highlighted at the AAPS National Biotechnolgy Conference in Boston this week. More than 1100 attendees from 19 countries participated in the event.

GlaxoSmithKline PLC (GSK, London, UK) will invest more than GBP102 million ($188 million) over the next four years in a vaccine manufacturing plant in Singapore.

This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

The biggest single recent trend in outsourcing solid-dosage processing has been the movement toward discovery and synthesis of more potent active pharmaceutical ingredients.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

Bringing Exubera to market requires extensive collaboration by Pfizer, Nektar Therapeutics, West Pharmaceutical Services Tech Group, and Bespak.

Using Bezier curves, an experimental process controller has been developed for biosynthesis applications in which the inactivity of a pH-sensitive enzyme must be decreased. By taking into account various control scenarios of pH and growth rate, as well as the physical and chemical characteristics of the environment, a suitable human-machine interface can be developed.

Any aseptic processing technology that allows intervention by gowned personnel during operation cannot be considered an advanced technology. Although a standardized definition of restricted access barrier systems has been developed, these systems fall well short of being classfied as advanced technologies.

The industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.

There are few, if any, valid reasons not to install an isolator in a new aseptic processing facility.

Bang & Olufsen Medicom (Copenhagen, Denmark, www.medicom.bang-olufsen.com), a drug-delivery device solutions provider, and Bespak (Milton Keynes, UK, www.bespak.com), a medical-devices and inhalation-valve technologies company, established an exclusive partnership to codevelop and comarket the ?Assist Actuated Inhaler,? a single-increment, dose-counting inhaler. The integrated device features an assisted firing mechanism for easier patient use, according to a company release.

Novartis (Basel, Switzerland) has closed on its $5.4-billion acquisition of Chiron Corporation (Emeryville, CA), paving the way for the creation of a new Novartis division focusing on vaccines and diagnostics.

This review article discusses orally disintegrating tablets and their manufacturing technologies, development issues, and future trends.

The common crystal form of ibuprofen was changed to optimize processing and manufacturing properties. Six modified crystal forms were prepared and assessed for dissolution, morphology, particle size, density, thermal characteristics, powder x-ray diffractometry, flow properties, and tabletability.

Sandoz (Holzkirchen, Germany), the generics division of Novartis (Basel, Switzerland) received European marketing authorization for its recombinant human growth hormone, ?Omnitrope? (somatropin), making it the first biogeneric product approved under the biosimilar pathway of the European Commission.

Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.

FTC Plans to Study Competitive Impacts of Authorized Generic Drugs

Reverse Genetics Avian Influenza Vaccine Approved in France

GSK Begins Clinical Trials of Two H5N1 Vaccines

Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.

Creation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4

Once the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.

Progress Continues in Vaccine and Antiviral Development

BMS, Sanofi-Aventis Settle Over Generic Plavix