API Synthesis and Manufacturing, Small Molecule

Pfizer’s acquisition of Array BioPharma expands the company’s pipeline of investigational cancer therapies.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

Automated candle and pressure-plate filtration equipment for removing catalyst residues from API slurries are operated in a closed system.

Cambrex’s expanded quality control laboratory supports generic API development.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

Antibody-based drugs offer new mechanisms of action and greater specificity.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

Demand for highly potent APIs continues to rise.

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).

Integration of new modeling and analytical tools with flow chemistry are notable trends.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

The $425-million acquisition adds formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network.

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Existing software tools cannot take into account the complexity of disease.

Low-temperature chemistry enables performance of more challenging and selective chemistry.

Determining how much containment is needed for API handling requires evaluation of multiple factors.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

Cambrex invests $5 million in new laboratory expansion at its Karlskoga, Sweden facility.