Manufacturing

The ¤9.5 billion therapeutic antibody market comprises over a dozen antibodies that have been generated using recombinant genetic methods developed over the last 20 years.

This article examines what other industries have done to address the challenges associated with successfully implementing the principles and concepts of process analytical technology, particularly the specific elements of measurement, analysis, and control. The author explores how other industries' approaches can be applied directly to pharmaceutical manufacturing.

Modeling conducted in the process development and early commercialization stages can increase process efficiency and lead to process-control improvement. A virtual plant environment, running on a PC, can incorporate the same industrial control systems and configuration expertise used in manufacturing and helps many parts of process analytical technology. It also can make possible the enlightened use of technologies such as model predictive control, first-principal models, neural networks, and multivariate statistical process control.

The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.

Growth in the global pharmaceutical market is expected to slow in 2007, based on the industry's increasing reliance on niche and specialty products and greater generic drug penetration, according to a forecast by IMS Health. Generic drugs, along with biotechnology and specialist-initiated products, are expected to outperform the overall market in 2007. Despite slower growth in the United States and Europe, growth in emerging countries, including China, is projected in the double digits.

SAFC Pharma has been appointed by BTG to provide chemical development services relating to BGC20-1259, a potential treatment for Alzheimer?s disease.

Cambrex Corp. signed a definitive stock-purchase agreement to sell two of its human-health facilities to a holding company controlled by International Chemical Investors II S.A. (Frankfurt, Germany).

Indianapolis, IN (Oct. 17)-Eli Lilly and Company agreed to acquire ICOS Corporation (Bothell, WA) for $2.1 billion.

Washington, DC (Oct. 13)-In a four-year study of pharmaceutical manufacturing, two business scholars found that initiative and information correlate with high productivity.

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.