Manufacturing

New York, NY (Oct. 19)-Pfizer, Inc. plans to implement a new company-wide cost-cutting initiative in 2007 as part of strategy to improve operating performance. The cuts are in addition to a previous cost-reduction program that Pfizer launched in 2005.

CPhI Worldwide, Paris (Oct. 3)-Archimica, participating in its first CPhI Worldwide exhibition since being launched as new company earlier this year, outlined manufacturing expansions, technology additions, and recent projects at its facilities in the United States and Europe.

CPhI Worldwide, Paris (Oct. 3)-The Synthetic Organic Chemical Manufacturers Association and the European Fine Chemicals Group have teamed to urge US and European regulatory authorities to increase inspections of foreign manufacturing facilities of active pharmaceutical ingredients (APIs) to reduce patient risk from sub-par drugs, to increase national security, and to level the economic playing field.

Cramlington, UK (Oct. 9)-Aesica, a supplier of active pharmaceutical ingredients (APIs), announced it had acquired a chemical-manufacturing facility at Ponders End, UK from Merck Sharp and Dohme Limited, the British subsidiary of Merck and Co., Inc.

CPhI Worldwide, Paris (Oct. 3)-Exhibitors at CPhI Worldwide reported expansions, enhancements in technology, and new projects last week in Paris.

CPhI Worlwide, Paris, (Oct. 5)-Following its recently announced acquisition of EaglePicher Pharmaceutical Aptuit, Inc. plans further investment in infrastructure and staff in building its capabilities in manufacturing active pharmaceutical ingredients (APIs).

CPhI Worldwide, Paris (Oct. 3)-Carbogen Amcis AG, a subsidiary of Dishman Pharmaceuticals and Chemicals Ltd., is planning several investments in its pharmaceutical chemical development and manufacturing activities.

New York (Oct. 9)-Pfizer has positioned itself to enter the DNA-based vaccine market with its agreement to acquire UK-based PowderMed Ltd., which holds a pipeline of DNA-based influenza vaccines currently in clinical development for treating both seasonal and avian flu.

Foster City, CA (Oct. 2)-Gilead Sciences, Inc. has agreed to acquire the biopharmaceutical company Myogen, Inc. for $2.5 billion.

SAFC, the custom manufacturing group of Sigma-Aldrich Corporation, announced at CPhI Worldwide that it will invest $16 million to expand its CGMP protein-purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

Paris (Oct. 3)-In gearing up for opportunities in the generic drug market, Codexis, which specializes in biocatalysis for pharmaceutical chemical development, is expanding into direct sale of pharmaceutical intermediates with the receipt of its first commercial orders from generic drug manufacturers for ATS-8, a chemical intermediate in atorvastatin, the API in Pfizer's top-selling drug ?Lipitor.?

London (Sept. 29)-GlaxoSmithKline will invest more than ? 500 million in a vaccine-manufacturing plant in St-Amand-Les-Eaux, France. The investment will expand the company?s production capacity in formulation, filling, freeze-drying, and packaging in response to increasing worldwide demand for pediatric and adult vaccines.

Merck's new supply strategy involves combining internal and external manufacturing.

Biologics are forecast to account for roughly 60% of revenue growth through 2010 for Big Pharma as growth in small molecules slows. The author analyzes the factors driving demand and how the technology life cycles of these two sectors will affect market potential.

Increasing costs for Indian-based CMOs may be reducing their total cost of ownership advantage.

A recent analysis found that 9000 marketed drugs are not in FDA's National Drug Code Directory.

Whether you advance your technology from concept to commercialization or use a third party for parts or all of this work, the ability to do technology transfer flawlessly is essential to successful, efficient pharmaceutical production.

Glasses are important when operating in a sterile environment, and it is necessary to ensure that they will stand up to repeated sterilization processes without introducing contaminants. The glasses were subjected to numerous steam sterilization cycles to assess durability and microbial reduction. Results showed that the glasses most widely available on the market have been refined by the manufacturer to satisfy pharmaceutical customer needs by withstanding repeated sterilization cycles and minimizing contaminating particle release.

Nondestructive testing takes many forms and is gaining favor because it saves time and prevents costly product loss.

Plastic has emerged gradually as a viable packaging material, even for sterile products. Acceptance of plastics has been encouraged by blow–fill–seal (BFS) technology, which provides scientific and commercial benefits. BFS technology has, however, brought new challenges for formulation-development scientists. This article highlights the specific concerns for the development of sterile liquid products and the formulation strategies to address these concerns.

Pharmaceutical companies are facing increased competition, cost pressures, and a need to improve the performance of their manufacturing operations. Lean manufacturing offers methods, tools, and heuristics for improved efficiency in manufacturing. Process analytical technology offers alternative analysis techniques that could greatly improve manufacturing quality and efficiency. Mathematical tools exist for assessing the efficiency of manufacturing processes. Internal benchmarking is recommended for determining the efficiency and tracking improvements in pharmaceutical manufacturing.

Protein formulation specialists have long sensed that something big could be just around the corner. Over the past few decades, countless companies have attempted to bring to market new protein therapeutics that offer improvements-be they more patient friendly, more effective, or easier to manufacture-over traditional formulations. Earlier this year, the launch of Pfizer's "Exubera" pulmonary insulin met this anticipation head on. The fast-acting, inhaled-powder form of recombinant human insulin brought hope to the millions of diabetic patients waiting for an alternative to injections.

There is a growing need for patient-compliant dosage forms within the cancer therapeutics and biotechnology areas. Ease of administration, enhanced therapeutic efficacy, and reduced side effects are factors that differentiate drug delivery products from conventional dosage forms and provide a competitive advantage. This article reviews salient trends in the parenteral drug delivery sector within the realms of a changing regulatory environment, drivers to growth, and recent advances in this field. Challenges associated with bringing parenteral drug delivery concepts to commercialization are discussed.

More CMOs look to proprietary delivery technologies to enhance profitability.

In view of the nature of its complexity, it might be desirable to apply FDA's process analytical technology to lyophilization.

The increasing popularity of orally disintegrating tablets has led to growing interest in the advantages of superdisintegrants. This article presents some practical considerations in selecting these ingredients.

UK science has an outstanding record and we remain strong internationally in terms of achievement, productivity and efficiency.

Developed in the 1950s as a means to survive and compete against the giants of the automotive sector, lean manufacturing helped Toyota evolve from a small-volume producer (with little capital) to become a high-volume manufacturer in a process-rich environment. Toyota achieved this by using developments such as total production maintenance (TPM), just-in-time (JIT), Kanban, value stream mapping and Kaizen events.1 A summary of some of the lean terminology is shown in Table 1.

Aptuit, Inc. (Greenwich, CT) has agreed to acquire the assets and operations of EaglePicher Pharmaceutical Services (EPPS, Lenexa, KS) as part of Aptuit?s strategies to build capabilities in active pharmaceutical ingredient (API) development and drug substance manufacturing.