APIs and Excipients

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

Boehringer Ingelheim and OSE Immunotherapeutics have entered a global immuno-oncology partnership to develop a checkpoint inhibitor for treating advanced solid tumors.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.

Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.