APIs and Excipients

With pharmaceutical tariffs fundamentally impacting costs, global supply chains, and more, it’s important for industry professionals to understand the basics.

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

Exosomes, polymeric nanoparticles, and DNA nanostructures offer many potential advantages.

The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.

This site was previously the beneficiary of a €7.3 million (US$7.6 million) investment, made in 2022, earmarked for the production of HPAPIs to treat cancer.

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, looks at what is involved in developing modern ADCs.

Increasing API and formulation complexity and new delivery strategies are driving innovations in taste-masking.

Process consistency and robustness, analytical excellence, and regulatory compliance are essential in the scale-up of biosimilars.

CDMOs who have integrated technologies can help further the advancement of ADC development.

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.

Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.

Results from a Phase IIb study missed the primary endpoint by failing to achieve statistical significance.

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.

In the collaboration, the new company, Oblenio Bio, has been granted an exclusive option to license LBL-051, a tri-specific T-cell engager antibody, from Leads Biolabs.

Automation, miniaturization, and new software algorithms are improving throughput and accuracy.