How Design Space Improves Lyophilization Cycle Success

How Design Space Improves Lyophilization Cycle Success

Release Date: April 10, 2019

SP Scientific conducted a video interview with Dr Kevin Ward of Biopharma Process Systems Ltd to discuss how expanding design space increases the probability of executing a successful lyophilization cycle.

The Quality by Design (QbD) approach to producing lyophilized products is increasingly being adopted in the pharmaceutical and biopharmaceutical industries. In the manufacturing environment, this translates into leveraging a sound understanding of operations to design a manufacturing process with defined multivariate parameter ranges that produce acceptable product quality attributes. In the QbD approach, this multidimensional combination and interaction of input variables, equipment limits and product limits can be mapped to create the viable design space for lyophilization of a given formulation.

Dr Ward discusses how operating a lyophilization cycle within the design space will result in a product meeting a predefined quality. Having a larger design space, or parameters in which to work, increases the probability of executing a successful cycle, even in the face of potential problems, such as process excursion due to unplanned power loss.

In addition, Dr Ward explains that by establishing an expanded design space, users can develop a more flexible approach in development and manufacturing process and it is then easier to implement continuous process improvement and maintain product integrity within the boundaries of that design space.

For the full video interview with Dr Ward please visit https://www.sp-lineofsight.com

About SP Scientific

SP Scientific is a leading manufacturer of freeze dryers/lyophilizers, aseptic vial washing and tray loading machines, temperature control/thermal management, centrifugal evaporators and concentrators, glassware washers, and controlled environmental rooms and chambers. The company sells its products under well-known brands including VirTis, Hull, PennTech, FTS Systems, Genevac and Hotpack. SP Scientific has ISO 9001:2015 registered production facilities in the USA and Europe.

Line of Sight™ is a breakthrough concept from SP Scientific comprising a suite of freeze-drying equipment with scalable lyophilization technologies and process analytical tools (PAT). Line of Sight has been designed for pharmaceutical developers and manufacturers to assist them achieve drug commercialization objectives. Line of Sight technologies have been developed to provide the tools for a more successful scale-up of a lyophilization process from formulation through to full commercial production. This ensures superior product quality and uniformity and creates a data rich environment across all sizes of freeze-drying systems. The next step forward in lyophilization, the science of freeze-drying, is being developed for pharmaceutical applications by use of enhanced technological capabilities, improved process and product understanding, and by implementing Line of Sight enabled freeze drying equipment. 

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