Development

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.

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

Steep price increases for a popular drug have created patient and Congressional backlash.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.