Andrew Sinclair

An environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.

An environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.

The authors compare the environmental impact of monoclonal antibody production using fixed-in-place processing and single-use systems.

Comparing the economic feasibility of a typical glycosylated protein.

Sanofi Pasteur's disposables implementation plan is part of a larger evaluation of technology innovation. Here's how they approach it.

An analysis of flow rate, load density, viral clearance, and cost.

How a Big Pharma company tackled the move to disposable bioreactors.

How this Big Pharma company successfully implemented disposable technologies in its manufacturing plant.

Suppliers, manufacturers, and governments must work together to plan how best to develop and deploy disposable systems for emergency response.

Single-use technologies can be configured and installed fairly quickly, but are they ready to handle the urgency and scale of a pandemic?

What end users think about single-use systems.

Cost modeling provides valuable insights to support strategic decision-making when implementing disposable technologies.

How to choose a disposable mixing system that fits your particular needs.

In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.

Can disposables reduce your facility's environmental footprint? We have compared the environmental footprint of a traditional biopharmaceutical manufacturing facility using fixed-in-place stainless steel equipment, and a facility implementing disposable technologies for cell culture, solution mixing and hold, product hold, and liquid transfer.

In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply.

The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis.

Disposable technologies that mimic the conventional stainless-steel bioreactor will be most readily adopted

The use of disposables has changed significantly in the biopharmaceutical industry.

Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects among groups are aggravated by a lack of common terminology and poor data management practices. A UK biotech consortium has initiated a collaborative development effort to address data management issues. The proposed outcome is a data model, based on the ISA-88 Standard for Batch Control, to capture process and facility data throughout the product lifecycle. A data framework that follows the ISA-88 model can simplify process scale up and enable early views of project costs and facility fit.