API Synthesis and Manufacturing, Small Molecule

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.

Porton will use biocatalyst technologies from Codexis to accelerate API development for clients.

The contract renewal allows AMRI to continue to provide medicinal chemistry and ADME services for advancing drug discovery programs in neurotherapeutics.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.

Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.

The performance of nanoparticles used as carriers in drug delivery is intimately linked to their physical properties. Nanoprecipitation is a common method for the preparation of drug-loaded polymer nanoparticles, but until recently, the reproducibility of the two primary dimensional descriptors-the average particle size and the breadth of the size distribution-has been a challenge due to the intrinsic variability of batch processes. Microfluidics-based flow techniques, however, reduce variation in drug-loaded polymer nanoparticle synthesis.

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.

Cambrex invests in development and laboratory facilities and adds staff.

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

Hovione has installed a new MG2 Tekna Precision Capsule filler at its Portugal site.

A ceremony was held at Cambrex’s Karlskoga facility to mark the commencement of a long-term manufacturing agreement with AstraZeneca for a key intermediate.

FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.

The method developed by Cambrex uses standard plant equipment and requires only two synthetic steps and one recrystallization, minimizing waste and use of solvents.

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

Industry experts were honored for business, scientific, and social contributions.

Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.

CDMOs sharpen skills for identifying API potency risks and establishing safety and handling procedures.

CordenPharma will expand development capacity for small molecules, peptides, and carbohydrates at its Liestal, Switzerland site

Compared to traditional drug discovery approaches, drug repurposing, repositioning, and rescue can be faster and cheaper.

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

Solid state solutions provider Holodiag and fine chemical R&D provider Holochem join forces.

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

BASF will build a new specialty amines plant at its existing wholly owned site in Nanjing Chemical Industry Park in China.