Development

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

This three-year partnership will explore and identify new tools and methods to modify and optimize the Chinese hamster ovary (CHO) cell line performance.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) using a small-scale model.

Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability.

Primary packaging and container design reflects a move to patient-friendly formulations and delivery systems.

Excipient selection strongly influences lyophilization performance for biologic drugs.

There is much work to do to achieve efficient, cost-effective production processes.

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

Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.

The baculovirus-insect cell system can produce large quantities of complex protein in a short period of time.

This report describes the first known attempt at quantifying the success of such processes in inducing nucleation on a 56–m2 freeze dryer operating at a load of 195,960 vials.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

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.

The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.

BioPharm International spoke with Trevor Marshall, director of enterprise systems integration at Zenith Technologies about automating processes in upstream processing.

Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

Plant transient expression offers a flexible approach in drug development and enables rapid production and scale up of therapeutics.

Experts discuss recent advances in cell viability testing methods in bioreactors.

A new study proposes a new way to potentially treat congenital diseases in utero.

Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn’s disease.

he guidance addresses the good manufacturing practice for managing quality in APIs.

High-purity low-endotoxin sugars improve robustness and stability of protein formulation and improve drug product quality.