APIs and Excipients

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.

The collaboration aims to advance clinical development of a Phase I drug candidate, MRT-6160, and to explore other therapeutic opportunities across multiple indications.

Merck will deploy Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

Sustainability of small-molecule API manufacturing ensures continued success.

The company will be introducing its new low-substituted hydroxypropyl cellulose and its improved polyplasdone LN superdisintegrant at the October 2024 events.

The critical APIs that this funding will contribute to are used in the treatment of asthma, diabetes, and anxiety disorders.

Greater collaboration and understanding are needed to ensure the correct grade of excipient is used in drug products.

In this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.

Qualifying material suppliers is a crucial step in ensuring safe and effective drug products.

Merck, known as MSD outside of the United States and Canada, will gain CN201, a next-generation bispecific antibody, from Curon Biopharmaceutical in a deal potentially worth up to $1.3 billion.

Genentech will have access to Sangamo’s capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines for certain neurodegenerative diseases.

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.

A holistic approach to automation can provide benefits at all stages of development and manufacturing.

Platform processes and effective risk assessments help overcome time and cost challenges.

With the Series A funding, the new biotech company will advance the development of enhanced biologics for treating solid tumors and inflammatory and immunology diseases.

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.

GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.

With this acquisition, AstraZeneca gets a Phase III therapeutic peptide candidate that adds to the company's rare disease pipeline.

Johnson & Johnson gains NM26, a Phase II-ready bispecific antibody in development for atopic dermatitis, boosting its immune-mediated and inflammatory disease portfolio.

Weighing development costs/resources and performance benefits is essential.

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.