API Synthesis and Manufacturing, Small Molecule

Operator, caregiver, and patient safety are at the forefront when selecting the best options and dosage forms.

The expansion will be designed to meet the growing demand for small molecule drug substance development and manufacturing.

Biological and analytical advances enable modern fermentation processes to deliver safe and effective next-generation medicines.

Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.

For certain APIs, including semi-synthetic antibiotics, continuous filtration and drying improves productivity and quality.

CARBOGEN AMCIS has announced significant investments to increase manufacturing capacity in Switzerland and France.

Atomwise’s technology, AtomNet, works to eliminate the barriers of physical screening for small molecule drug discovery.

CordenPharma added a 3000-L solid-phase peptide synthesis vessel to its GMP API facility in Boulder, CO.

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

Quartic.ai and Bright Path Laboratories have agreed to develop an artificial intelligence (AI)-powered continuous manufacturing platform for APIs and other small-molecule drugs using Bright Path Labs’ continuous bioreactor and the Quartic.ai smart manufacturing technology.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

The technology center is dedicated to developing greener, safer chemistries for manufacturing pharmaceutical raw materials and intermediates.

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.

Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.

An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.

EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.

The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

New CDMO facility supports early-stage API manufacturing and scale up.

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.