Ingredients

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.

Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.

BASF receives EXCiPACT Certification for the group of polyvinylpyrrolidone polymers, produced in Germany.

Avantor Performance Materials adds VWR International locations to its certified excipient distributor program.

CPhI-InformEx Report will to describe American pharma economy from European and domestic perspectives.

Emerging markets are an engine for growth in the custom-manufacturing and pharma markets.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.

Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

With the enforcement of the European Directive 2011/62/EU relating to medicinal products for human use regarding falsified medicinal products, new requirements are introduced for active substances. The new regulation requires among other things, documentation of the supply chain traceability.

Cedarburg Hauser Pharmaceuticals has upgraded its API plant in Wisconsin.

Pfizer advances its pipeline of antibody-based therapies using a host cell line that combines engineered glycosylation technology and enhanced gene-expression.

New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.

Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

Commercial-scale amide formation and an improved process route for a tetracycline derivative are some recent developments in API synthesis.

A recent FDA guidance places greater attention on cocrystals as a tool in solid-dosage formulation.

Industry experts share perspectives on risk assessment and mitigation in excipient manufacture and the excipient supply chain.

A simple, rapid analytical method for the determination of palladium in pharmaceutical production samples will speed up development and optimization of reactions involving palladium catalysts.

Stapled peptides offer promise to enable cell permeability, binding to therapeutic targets, and modulation of biological pathways.

View companies' outsourcing profiles from PharmTech's 2013 Outsourcing Resources Fast Locator Index in the following categories.

Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers to better secure the pharmaceutical supply chain.

Industry groups offered perspectives on the strengths and weaknesses of the European Falsified Medicines Directive.

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.

Novel, atom-efficient routes to amides from esters and carboxylic acids for more sustainable manufacturing.

New routes enable the efficient synthesis of enantiopure sulfinamides and structurally and sterically diverse P-chiral phosphine oxides.

Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.

The US and EU move forward with measures to fortify the pharmaceutical supply chain.

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.