APIs and Excipients

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.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.

Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.

The performance of nanoparticles used as carriers in drug delivery is intimately linked to their physical properties. Nanoprecipitation is a common method for the preparation of drug-loaded polymer nanoparticles, but until recently, the reproducibility of the two primary dimensional descriptors-the average particle size and the breadth of the size distribution-has been a challenge due to the intrinsic variability of batch processes. Microfluidics-based flow techniques, however, reduce variation in drug-loaded polymer nanoparticle synthesis.

The authors discuss expectations of regulators on the selection of drug substance regulatory starting materials (RSM) and the justification of their designation in the pharmaceutical supply chain, the scope of the RSMs' presentation required in regulatory filings, and how to mitigate and prepare for "push backs" in the event of a major objection to the sponsor's RSM designation.