Manufacturing

The tightening of intellectual property rights in India under GATT/TRIPS was a crucial inflection point for pharmaceutical outsourcing in India.

Risk management is essential in any successful outsourcing partnership. The author outlines the steps toward identifying, understanding, and controlling risk in key manufacturing areas.

The authors analyze the supply–demand trends for contract biologics manufacturing and the strategies of pharmaceutical and biotechnology companies and their suppliers in the value chain.

This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.

Infrastructure must be in place before jumping into outsourcing.

Using basic project management tools and ideas in the transfer process saves time and money and ensures high success rates.

Catalysts are important tools in the synthesis of active pharmaceutical ingredients. Recovery of precious-metal catalysts from a pharmaceutical manufacturing process is a factor in cost control and environmental compliance.

The company begins production at a new $100-million manufacturing facility for prefilled injection systems, plans further investment in packaging facilities, and targets both early-phase development and commercial manufacture.

Catalytic routes to producing atorvastatin and sitagliptin are recent advancements.

Merck & Co. acquires NovaCardia, Sanofi Pasteur completes vaccine-manufacturing facility, more

An industry survey finds that pharma's outsourcing practices keep the industry from reaping the full benefits of outsourcing.

Novartis Vaccines plans to produce approximately 40 million doses of its ?Fluvirin? vaccine for distribution in the United States during the 2007?2008 flu season.

The European Medicines Agency?s (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted 11 positive opinions, 3 of which are tied to similar biological medicinal products.

More than five million US adults import prescription drugs from other countries, according to a survey conducted by the Pharmaceutical Research and Manufacturers of America.

Novartis Vaccines and Diagnostics, a division of Novartis AG (Basel, Switzerland) and IntercellAG (Vienna, Austria), a biotechnology company, will collaborate toward developing a broad range of vaccines.

Abraxis BioScience, Inc. plans to separate its hospital-based product business, Abraxis Pharmaceutical Products (APP), from its proprietary products businesses, Abraxis Oncology and Abraxis Research, to form two public companies. Abraxis Pharmaceutical Products will become APP Inc., and Abraxis Oncology and Abraxis Research will become the new Abraxis BioScience.

This article looks at the current good manufacturing practice regulations from a statistical perspective while addressing their requirements and implications and inviting the industry to assess its past performance in meeting the regulations.

An industry survey finds that pharma's outsourcing practices keep the industry from reaping the full benefits of outsourcing.

Drug packaging performs functions such as ensuring patient well-being, providing information, preventing tampering, blocking counterfeiting, and improving compliance. Since 1977, packaging innovations have occurred in four major categories. The author provides an overview of major packaging improvements that have emerged in the past 30 years.

As a well-known and well-respected researcher, director, and speaker Fernando Muzzio shares his insights into the significant steps that have led to the "unprecedented" manufacturing industry of today.

A review of advancements in areas such as active ingredients, formulation, technology, regulation, and analytical testing.

Fundamental validation skills related to heating, ventilation, and air conditioning must be thoroughly understood. Knowing the early history and development of validation is essential to understand the current set of regulations and standards governing the industry. This article reviews the history and outcome of contamination in large-volume parenteral drug products and discusses the qualification requirements of modern HVAC systems.

While recapping the past 30 years' innovations in pharmaceutical technology, it's also important to start preparing for the next 30 years. But staying ahead of the curve will be challenging.

Automation took hold gradually in the life-science industry. Its adoption brought the industry innovations and improved efficiency. Recent years witnessed the emergence of batch-automation systems and the development of standards for automation. The authors discuss the major changes automation brought to the industry and examine the rapid pace of technological development.

Bioanalytical Systems (West Lafayette, IN) extended the employment contract of its president and CEO, Richard M. Shepperd, through December 31, 2009. Shepperd has served as interim president and CEO since October 2006.

Thirty years ago, the world was a very different place; so was the pharma industry.

Sterile product manufacturing and related testing have evolved significantly during the last 30 years. From requirements for acceptance criteria for media-fill tests, to developing validated approaches for moist-heat sterilization, to the introduction of formalized sterility-testing practices, the pharmaceutical industry has made significant advances in testing and in key technology such as isolators, prefilled syringes, automation, and robotics. The author outlines the key regulatory and technical changes to sterile product manufacturing and takes a visionary look for the next era of sterile manufacturing marked by a greater emphasis on risk analysis.

Trenton, NJ (May 18)-Pharmaceutical and medical technology companies in New Jersey have found a striking disparity between six high-demand occupations and the number of qualified workers to fill those positions, according to a report issued by the HealthCare Institute of New Jersey (HINJ). Modest job growth in this field is expected for the next four years, states the report.

Traditionally, in pharmaceutical water systems the main method for controlling bacterial levels was heat or chemical sanitants...

Drug companies have come to realize that spending heavily on creating new blockbuster drugs is risky and less cost-effective ...