Development

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.

Multiparticulates are increasingly used due to their flexibility in providing controlled-release, fixed-dose combinations, ease of taste-masking, and suitability for pediatric applications

Challenging molecules and markets are driving the development of new solutions for drug delivery.