Development

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

Industry experts spoke to BioPharm International about the key considerations in the development of a drug-delivery device for a biologic drug, the importance of human factors engineering, the advantages of prefilled syringes, and the challenges in the manufacture of these devices.

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Gene and cell therapies represent the next-generation treatments for a wide range of diseases, but one challenge in the development of these therapeutics is the controlled delivery to the targeted site to maximize expression or engraftment while limiting systemic exposure.

This article discusses cleaning validation of equipment dedicated to the production of a single API.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

The Catalent Applied Drug Delivery Institute and AAPS recognize four groups for emerging scientific talent and academic excellence.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Catalent licenses Excelimmune’s antibody combination therapy platform toenable the manufacture of multiple recombinant antibodies in a single batch culture.

When using media supplements in biologics, it is important to have a key understanding of both the supplement and the base medium to ensure high titer and stability.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with BioPharm International about collaborative success strategies for biopharm companies.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Contract service providers share insights on biopharma market developments and the implications of biosimilar drug approvals.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.