Manufacturing

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

Despite the poor economic climate, large-scale mergers and acquisitions in the pharmaceutical industry struck back with a vengeance in 2009.

Bristol-Myers Squibb's fit-for-purpose mode for clinical-trial materials for early-stage development seeks to achieve a better way in resource allocation. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

The current trend in the pharmaceutical industry for the manufacture of small-molecule therapeutic agents is moving toward continuous flow processes. This article is part of a special issue on APIs.

In an increasingly competitive landscape, outsourcing providers are under mounting pressure to get their name out there and secure new and repeat business.

The author presents recent developments in simulated moving-bed chromatography in production of active pharmaceutical ingredients and intermediates. This article is part of a special issue on APIs.

The author explains the background behind the excipient pedigree and how to implement its use.

Every biopharmaceutical is unique and products are defined as much by their manufacturing process as their analytical characterisation. Because of this, the development of biologics has many inherent complexities over small molecule projects.

The authors discuss a continuous-flow reactor that avoids parallel channels and enables economic plant setup. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

In light of the impressive size and predicted growth of the market, there has been a rising interest in the development of biosimilars.

The manufacture of high potency active pharmaceutical ingredients (HPAPIs) is on the rise with R&D projects showing a continuing interest in these products.

Industry experts discuss the merits of continuous processing technology and explain why pharma manufacturers should realize the benefits these technologies offer.

The authors describe several examples of using asymmetric hydrogenation and biocatalysis for synthesizing several secondary alcohol compounds.

Many hurdles lie between a biosimilar and success on the market. In particular, there are three main questions that companies will be asking themselves.

A case study describing how Lean can drive the creation of an improved culture within pharmaceutical companies.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

Last year, the global market for biological products exceeded $125 billion, accounting for 17% of the total market for pharma/biopharma products.

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

The future of pharmaceutical R&D may lie in open-source research, with key data being made available to a number of people, including college students and university researchers, in an open and collaborative process.

US Department of Health and Human Services (HHS) Secretary Kathleen Sebelius released last week an examination of the federal government's system to produce medical countermeasures, or medications, vaccines, equipment, and supplies needed for a health emergency.

Two new reports describe the vaccine market's recent growth and predict future market expansions.

Members of a UK trade union working at AstraZeneca have voted to strike following cuts in pension benefits.

The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.

The Society of Chemical Manufacturers and Affiliates (SOCMA) welcomed the signing of HR 4380, the United States Manufacturing Enhancement Act of 2010, also known as the Miscellaneous Tariff Bill (MTB) into law (Public Law 111-227) by President Barack Obama on Aug. 11, 2010.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.