The Significance of Pilot Scale-Up
Some equipment is different from development (small scale) to GMP manufacturing (large scale), such as fermenters and centrifugation. Pilot scale-up is the crucial stage to bridge the gap between development and large-scale or commercial scale. A pilot scale-up could be conducted before proceeding with large-scale production, which can test and optimize the process of drug substance (DS) during small-scale development and manufacturing.
Keywords: from lab-scale to pilot-scale and large-scale, from laboratory and development stage to pilot and production-scale, bioprocess scaling up
Application: technology transfer, biopharmaceutical industry, human medicine, animal medicine, vaccine, recombinant large molecule biologics, recombinant biologics, biological reagent
Pilot Scale-Up Services of Yaohai Bio-Pharma
GMP-like Pilot Scale
- 30L, 70L stainless steel stirred fermenters.
- Corresponding centrifugation, high-pressure homogenization, and chromatography system.
- Quality control (QC) and quality assurance (QA) for DS on site.
- Deliverables including all relevant documentation (process suitable for GMP manufacturing scale scale) and non-GMP DS.
Service Details
- Upstream fermentation process scale-up
- Downstream purification process scale-up
- Process optimization
- Process transfer to large-scale manufacturing
Types of Organisms
Bacteria (Escherichia coli)
Yeast (Pichia pastoris, Saccharomyces cerevisiae, and Hansenula polymorpha)
Other microorganisms that require biosafety levels (BSL-1 or BSL-2) laboratories.
Types of Products
Recombinant subunit vaccine, virus-like particles (VLP) vaccine, single-domain antibody (sdAb), antibody fragments, peptides, cytokines, growth factors, enzymes and other proteins, plasmid DNA (pDNA).
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