• Over 10 years of experience in purification of animal-based Over 10 years of experience in purification of animal-based extracts (serum, milk, egg,…) extracts (serum, milk, egg,…) • Expert in chromatography & other key purification technologies Expert in chromatography & other key purification technologies • Recognized technical expertise Recognized technical expertise • In-house & high-performance equipment In-house & high-performance equipment purification services for animal extracts Novasep is recognized for bringing the best to purification using industrial chromatography and integrated additional technologies for improving/optimizing your purification process Capacity to develop processes including several steps (chromatography, tangential filtration, clearance viral step) 80% of the process steps use Novasep’s own proprietary equipment: Hipersep Bio ® for chromatography batch up to 450 mm column diam., UFDF (Tangential Flow Filtration) Facilities inspected by the ANSM (France) in 2017 & the FDA (US) in 2014 Did you Did you know? know? Did you know? • Ability to reach a wide range of purity levels Ability to reach a wide range of purity levels • Outstanding regulatory track-record Outstanding regulatory track-record • Development of innovative processes Development of innovative processes • Improvement of processes to support productivity Improvement of processes to support productivity Hipersep ® Bio Bio SC ® UFDF, filtration and other types of filtration Analytical: HPLC, UPLC, Elisa & SDS-Page, UV, Bioburden, Endotoxin capabilities capabilities Our Our Our capabilities
3
Embed
NOVASEP HAS THE CAPABILITIES AND THE EXPERTISE ......fine chemicals NOVASEP HAS THE CAPABILITIES AND THE EXPERTISE TO BRING YOUR ANIMAL EXTRACT TO THE PURITY LEVEL REQUIRED • Ability
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
• Over 10 years of experience in purification of animal-based Over 10 years of experience in purification of animal-based extracts (serum, milk, egg,…)extracts (serum, milk, egg,…)
• Expert in chromatography & other key purification technologies Expert in chromatography & other key purification technologies • Recognized technical expertiseRecognized technical expertise• In-house & high-performance equipment In-house & high-performance equipment
purification services for animal extracts
Novasep is recognized for bringing the best to purification using industrial chromatography and integrated additional technologies for improving/optimizing your purification process
Capacity to develop processes including several steps (chromatography, tangential filtration, clearance viral step)
80% of the process steps use Novasep’s own proprietary equipment: Hipersep Bio® for chromatography batch up to 450 mm column diam., UFDF (Tangential Flow Filtration)
Facilities inspected by the ANSM (France) in 2017 & the FDA (US) in 2014
Did youDid you
know?know?Did you
know?
pharmaceuticals
biopharmaceuticals
bio-industries
agrochemicals
functional ingredients
food ingredients
fine chemicals
NOVASEP HAS THE CAPABILITIES AND THE EXPERTISE TO BRING YOUR ANIMAL EXTRACT TO THE PURITY LEVEL REQUIRED
• Ability to reach a wide range of purity levelsAbility to reach a wide range of purity levels• Outstanding regulatory track-recordOutstanding regulatory track-record• Development of innovative processesDevelopment of innovative processes• Improvement of processes to support productivityImprovement of processes to support productivity
PROJECT SCOPE Analytical method transfer, process development, scale-up and clinical production
TIMING Multi-year collaboration
Development & purification of a polyclonal antibody from a serum for the pharmaceutical market
A success story concerning the process development & scale-up of a polyclonal antibody for clinical studies
Novasep’s purification experts took care of process development and optimization at R&D scale in Pompey (France) including implementation of viral clearance steps. Then, Novasep moved to scale-up the process at pilot-scale and deliver engineering & clinical batches.
Novasep was approached by a biotech company looking for a reliable CDMO partner to develop a purification process for a polyclonal antibody. The product was in preclinical phase and the customer required to complete the process development of its drug substance for preclinical & clinical studies.
TheThe
solutionsolutionThe
solution
TheThe
challengechallengeThe
challenge
CASE STUDYCASE STUDYY Y+2 Y+4Y+1 Y+3 Y+5
Analytical Analytical ServicesServices
ProductionProduction Small Scale Small Scale
Production Production Large ScaleLarge Scale
PURIFIED PURIFIED POLYCLONAL POLYCLONAL
ANTIBODYANTIBODY
Serum Serum
Process Process DevelopmentDevelopment
Figure 1:Figure 1: Process development and manufacturing of an animal extract
Precipitation+Precipitation+Depth Filtration or centrifugation
Development & Scale-up Novasep’s experts first transferred the client’s process at R&D scale and proceeded with the process development. Viral cleareance steps were implemented at this stage in order to meet regulatory safety constraints. In parallel, analytical methods were transferred and fine-tuned. Then, Novasep worked on scale-up and deliver engineering batches.
CLINICAL PRODUCTION & PROCESS CHARACTERIZATIONThe first clinical batches were delivered. A second scale-up was carried out and enabled to release engineering batches before clinical ones.
Successful delivery of the polyclonal antibody at hundred g-scale thanks to a strong process development & successful validation of the viral clearance steps
Purity reached > 90%
Next steps: process characterization and validation to support the commercial production
One manufacturing site for the purificationof your biomolecules operating in France: Pompey
NOVASEP HAS THE CAPABILITIES AND THE EXPERTISE TO BRING YOUR ANIMAL EXTRACT TO THE PURITY LEVEL REQUIRED
TheThe
outcomeoutcomeoutcomeThe
Services and technologies for the life science industries