Drug Development

A pilot project, beginning in 2017, will support the development of biosimilars.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.

Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.

Researchers test the efficacy of a new polymer that is an alternative to PEG for drugs used to treat type 2 diabetes.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

British artificial intelligence company BenevolentAI has signed an exclusive license for a series of novel clinical-stage drug candidates with Johnson & Johnson.

Envigo’s new assessment program can help identify if a drug has possible risk factors associated with hepatotoxicity.

The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.

Researchers in the University of Dundee have discovered a new method of activating drugs to combat visceral leishmaniasis. The discovery could lead to better treatments for neglected tropical diseases.

The new facility will focus on formulation development, drug product analytical development, and quality control.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.