White Papers

→ Capacity Planning in Biomanufacturing

In this whitepaper we examine the key metrics involved in capacity decisions for biopharmaceutical operations. We demonstrate how to model demand as well as existing and new supply capacity in the 1-10 year planning horizon. Using simple models of risk and variability, we demonstrate how integrated ‘supply-demand’ models can be used to accurately predict and prepare manufacturing capacity for the pipeline.

→ Debottlenecking and Process Optimization

Debottlenecking and process optimization are increasingly critical for biomanufacturers to improve run-rates, lower costs and drive excellence. In this whitepaper we'll examine the unique challenges for debottlenecking biopharmaceutical processes. We show how, using process optimization, organizations can improve visibility of their manufacturing operations.

→ Quality by Design in Biomanufacturing

QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process. This whitepaper looks at how biomanufacturing organizations can achieve continuous quality verification. We focus on simple, practical examples of how top-tier biomanufacturers have implemented QbD.

→ Scheduling Biomanufacturing Operations

This whitepaper describes the complexity associated with scheduling biomanufacturing operations and presents the idea of "variability aware, always feasible" scheduling. We describe the need for scheduling that envisages the complete manufacturing system including upstream, downstream, resources, interdependencies, process support groups, ancillary staff, engineering and maintenance. A sophisticated scheduling system must also accommodate inherent biological variability which forces schedulers to continually re-plan as campaigns evolve to meet changing conditions in multi-product manufacturing facilities.

→ Biomanufacturing Supply Chains

This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network. We examine critical risks facing the industry and explain how to address them.

→ Biomanufacturing Flexibility

This white paper looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. We look at future proofing these facilities for higher titers and multiple product lines.

→ Biomanufacturing Complexity

This white paper addresses one of the most serious challenges facing biomanufacturing professionals today - how to understand and then deal with the extreme complexity associated with biotechnology manufacturing.

→ Turning Data Into Information

This white paper addresses how to deal with the avalanche of data facing modern biomanufacturing facilities. We look at how to categorize and make sense of this data, turning it into information to help the enterprise.