In-line monitoring / real-time release testing in biopharmaceutical processes - prioritization and cost benefit analysis

 Most product characterization and impurity testing in the biopharmaceutical industry is performed by off-line testing with some at-line testing, which results in a long lead-time for the release of drug product.

Achieving a reduced time-to-release for drug product is a key goal of the industry, as it is a way to lower production costs and accelerate speed to market. Developing in-line monitoring technologies is a fundamental enabler of real-time product release.

This paper outlines a way to evaluate and identify the most important critical quality attributes and in-process control parameters to move away from off-line testing in the quality control laboratory to in-line, on-line or at-line testing on the manufacturing floor.

The three main sections of the paper are:

Process workflow

A step-by-step process matrix and ranking methodology to prioritize critical quality attributes and critical process parameters based on ILM-RTRT needs. It describes critical control points for each attribute, which are unit operations in which the attribute can be controlled through measurements using feed-back/feed-forward control to ensure an attribute is in a desired range.

User requirement specification (URS)

A technology-agnostic URS was created for each of the ten prioritized attributes based on industry needs, including safety and regulatory requirements for any potential technology to be developed or improved by the industry.

Business case

The elements of business-case calculations and the considerations and assumptions are provided for a selection of attributes. Examples act as a guide to help users decide how to evaluate specific scenarios to apply this type of technology.

The white paper provides a basis for evaluating and developing new proof-of-concept ILM-RTRT technologies. To make these a reality, close collaboration between equipment suppliers, technology developers, innovation hubs and biologics end-users will be crucial.

Attached Files

ILM RTR in biopharmaceutical processes - prioritization and cost-benefit analysis May 2020.pdf
ILM RTR URS Cell viability May 2020(1).pdf
ILM RTR URS Amino acids May 2020(1).pdf
ILM RTR URS Aggregation May 2020(1).pdf
ILM RTR Charge profile, production bioreactor May 2020.pdf
ILM RTR URS Viable cell density May 2020(1).pdf
ILM RTR URS Titer product concentration May 2020(1).pdf
ILM RTR URS Glycosylation profile May 2020(1).pdf
ILM RTR URS Glucose May 2020(1).pdf
ILM RTR URS DNA and HCP May 2020(1).pdf
ILM RTR URS Charge profile, cation exchange bind and elute polishing May 2020(1).pdf
ILM RTR Appendix for URS May 2020(1).pdf
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