Manufacturing, Biologics

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Communication and taking the time to develop the process are key to successful transfer and scale up of biologics

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

CellGenix will add R&D, production, and warehouse space in Freiburg, Germany for GMP-grade raw materials for cell therapy, gene-therapy, and tissue-engineered products.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

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.

On a recent call, Catalent revealed that it has reached more than 90% of its current capacity and discussed how tax policy changes could affect the outsourcing industry.

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.

Lek, a Sandoz company, adds capacity to its plant in Prevalje, Slovenia.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

UK-based Orchard Therapeutics and PharmaCell ally to support clinical trials and commercialization of Orchard’s ex-vivo gene therapies.

Consider best practices for placing, maintaining, and calibrating temperature sensors.

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.

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

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.

EMD Millipore’s Mobius Power MIX 2000 can mix buffers, culture media powders, and other challenging materials.

In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.

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

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

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.

BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

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