Ingredients

The long-awaited patent cliff that has loomed in the pharmaceutical industry for years has arrived in earnest in 2012, with more than $40 billion in 2011 brand sales facing loss of exclusivity.

Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

A review of taints and odors in the pharmaceutical and consumer healthcare industries.

Industry and academia advance novel approaches for achieving enanioselectivity.

The authors investigate the tablet-coating process using a combination of different simulation techniques.

Pfizer has two manufacturing facilities in Germany for high-potency manufacturing, respectively in Freiburg and Illertissen. Pharmaceutical Technology's Executive Editor Patricia Van Arnum visited the facilities and spoke to the company about the design and operation of these facilities.

The authors describe a QbD study that was performed to optimize a coating system.

The authors explain chemical transformations that are achievable through certain biocatalytic routes.

Policymakers must balance fundamental issues involving access to medicines and pricing.

An industry roundtable representing Metrics, Cambrex, Carbogen Amcis, Euticals, Ferro Pfanstiehl, and SAFC.

The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms and APIs of generic drugs.

The author discusses strategies for preventing cargo theft.

Approaches to scaling up API syntheses center on ways to optimize process conditions and operability.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Enhancing bioavailability can be achieved through hot-melt extrusion or spray drying. Patricia Van Arnum interviews Bend Research to find out more about when to use each technique.

The manufacturing capacity-sharing model in biologics and Merck & Co. and MedImmune ushers in a new paradigm of "co-opetition".

An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.

Flow chemistry and microreactors offer an alternative to traditional batch manufacturing.

Holistic open learning networks offer a new drug R&D model for improving research outcomes.

Jim Miller, president of PharmSource, examines the future direction of CROs/CMOs and the factors influencing the pharmaceutical contract services sectors.

The past three decades have driven a purchasing evolution to a procurement revolution.

Tracking changes from spinoffs of chemical companies to life-sciences powerhouses.

Companies roll out expansions in manufacturing high-potency APIs and finished products.

Sponsor companies' increasing focus on strategic outsourcing has changed the rules of the game.

Flow chemistry and microreactors offer alternatives to traditional batch manufacturing.

Peptides and related technologies to are starting to improve production.

Industry wants more innovation, but can suppliers meet customer needs?

Partnerships between industry and academic medical centers are expanding to meet R&D needs.

Targeted polymeric nanoparticles are an important vehicle for controlling and targeting dosing of chemotherapeutic agents.

Advances in palladium-catalyzed hydrogenation, visible-light photocatalysis, and chemocatalyisis for heterocycles are some recent developments.