Small-Scale Process Development

For vaccine development, characterization, and control strategies, it is necessary to develop small-scale process models to help understand the product and facilitate process understanding, prediction and control. For years, Creative Biolabs has consistently and effectively supported the vaccine industry with a unique range of products and related services. We provide small-model generation to predict performance at scale and small-scale process development with scalability and repeatability.

In the development process, the scale-up model needs to be characterize and optimized. Often, the differences in scale make scale up and prediction uniquely challenging. How to generate a small model and how to calibrate the small model to reliably predict the scale up performance is very important. Small-scale model development must be scientifically and carefully designed to represent many of the functions and environments that will be presented on a large scale. If the model selection or range of parameters are not reasonable, then even the secondary model adjustment and correction can not make up for these problems.

Advantages

  • Generate product and process models at both scales
  • Exploration of effective experimental strategy
  • Effective development of available facilities
  • Effectively explore control strategies
  • Increase material usage
  • Reduce development costs
  • Save time on exploring developing solutions

Small-Scale Process Development

Features

  • Our small-scale models can be developed and used to support process development studies. We develop models that account for scale effects and are representative of the proposed commercial process. The scientifically justified model can enable a prediction of product quality, and can be used to support the extrapolation of operating conditions across multiple scales and equipment;
  • Assessments of the ability of the process to reliably produce a product of the intended quality (e.g., the performance of the manufacturing process under different operating conditions, at different scales, or with different equipment);
  • Establish appropriate specifications, identify critical process parameters, and establish manufacturing controls (e.g., using information from vaccine development studies regarding the clinical significance of quality attributes and the ability to control them during processing);
  • The information and data of our small-scale models guarantee the performance of the manufacturing process such that it will consistently produce APIs and drug products meeting those attributes relating to identity, strength, quality, purity, and potency, and that the commercial manufacturing process is capable of consistently producing acceptable quality products within commercial manufacturing conditions.

Small-scale experimental models must be first generated to represent conditions at scale as much as is practicable to cover the operational ranges represent conditions that occur in the full-scale process. As vaccine manufacturing specialists, Creative Biolabs has a wealth of expertise and access to the world's most advanced manufacturing equipment. We fundamentally understand the processes involved in small-scale vaccine production, the capabilities of the technologies used, and the engineering designs required to ensure that you operate optimally with the lowest possible maintenance costs.


Our services are for research use only. We do not provide services directly to individuals.


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USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-466-5530
Fax: 1-631-207-8356
Email: Europe
Heidenkampsweg 58, 20097 Hamburg, Germany
Tel: 44-207-097-1828 Email:


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