API Synthesis and Manufacturing, Small Molecule

Sustainability advances are being made, but more investment is needed.

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.

The new excipients manufacturing facility is expected to be completed in 2025.

The state of oral solid dose manufacturing is influenced by new approaches, novel technologies, and the structural evolution of the raw materials market.

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

Inhalation formulations are complex, and empirical data are essential for realizing optimal solutions.

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

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

China-based CDMO Asymchem acquires US-based chemical technology company Snapdragon.

The researchers will use 3D printing to design novel flow reactors and static mixers.

SEDDS and SMEDDS improve solubility and permeability while expanding efficacy and applicability.

Spectrum Chemical scientists give a shout-out to 10 chemicals impacting quality of life in conjunction with National Chemistry Week.

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.

AstraZeneca will establish an API manufacturing facility near Dublin, Ireland.

Curia plans to expand the site’s commercial capabilities with this move.

Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.

Almac Sciences has signed a manufacturing agreement with Pila Pharma for the production of the API XEN-D0501.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.

Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide room for future small-molecule technologies expansion.

Intensified and distributed manufacturing approaches create flexible, local capacity.

The companies will work to discover and develop RNA-targeting small-molecule therapeutics for difficult-to-address indications.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

The deal expands Wavelength’s drug substance manufacturing footprint and its API CDMO business.

The increased services will work in conjunction with the site’s SimpliFiH Solutions first-in-human services, which includes phase-appropriate drug substance and drug product development and manufacturing.

Advanced manufacturing technologies are available, but challenges need to be addressed.