Small-Molecule APIs

Continuous manufacturing and a quality-by-design development approach are a natural fit.

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

The collaboration partner for Willow is focused on more sustainable methods to manufacture intermediates and APIs at reduced cost and less waste, in addition to looking for Willow’s expertise in developing and scaling key ingredients.

Process control is essential for using continuous hot-melt extrusion to enhance solubility.

Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.

NRG Therapeutics and Domainex aim to develop novel small-molecule drugs to treat neurodegenerative disorders, such as Parkinson’s disease.

Lack of toxicity data and poor physicochemical properties must be overcome.

Evonik has launched new EUDRATEC technology to improve solubility and performance of oral small molecules.

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication.

Between dosage form versatility, product stability, lack of storage restrictions or need to refrigerate, and an easier means of purification, small-molecule APIs present an appealing market niche.

Drug makers are going beyond continuous improvement and green chemistry to increase the sustainability of small-molecule manufacturing.

SpringWorks Therapeutics and the Dana-Farber Cancer Institute will conduct further research into the therapeutic potential of combination therapy with nirogacestat and anti-BCMA agents for multiple myeloma.

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

Citing undisclosed allegations against Kodak, the DFC placed a hold on a potential $765 million loan to launch US-based API manufacturing.

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

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

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

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

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

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

Demand for highly potent APIs continues to rise.

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

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.

The acquisition will place Cambrex into the finished dosage form CDMO market.

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