APIs and Excipients

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Further advances in construct design and manufacturing scalability are still needed.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

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

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

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

ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.

The right processes used with the right excipient combinations address evolving formulation needs.

Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

Resolving operational bottlenecks makes mAb manufacturing more efficient.

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

Evonetix’s thermally controlled DNA synthesis technology is designed to enable highly parallel DNA synthesis in a benchtop platform.

Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

Roquette is investing €25 million at its site in Lestrem, France to strengthen its position in the polyols market.

New report released by USP offers a look into API supply-chain vulnerabilities.

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

Spectrum Chemical has further expanded its bioCERTIFIED product portfolio to support the growing global demand for new vaccines and therapeutics.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.

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.

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.

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