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• 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

Hipersep® Bio

Bio SC®

UFDF, filtration and other types of filtration

Analytical: HPLC, UPLC, Elisa & SDS-Page, UV, Bioburden, Endotoxin

capabilitiescapabilitiesOurOurOur

capabilities

TECHNOLOGIES Preparative chromatography, filtration, viral clearance

DEVELOPMENT STAGE Clinical phases

SCALE Hundred gram scale

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.

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solutionsolutionThe

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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

: Next steps

Transfer & Process

development

Scale-up & Engineering

batch productionScale-up &

Engineering batch production

Analytical method transfer & development

Analytical method validation & stability studies Stability studies

Process optimization

Clinical batch

Clinical batch

Process validation

Commercial production

Process characterization

Stage I:Stage I: Development & Scale up

Stage II:Stage II: Clinical Production & Process Characterization

Stage III:Stage III: Commercial Production

Antibodies purification processAntibodies purification process

Virus inactivationVirus inactivationLow pH

Capture stepCapture stepContinuous/batch chromatography

Protein A

Intermediate stepsIntermediate stepsIEX chromato.

Continuous/batch chromatography

Polishing step Polishing step (optional)

Virus removal Virus removal Nanofiltration

UF/DFUF/DFFormulation

Concentration

0,22µm filtration 0,22µm filtration

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.

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© 2020 Groupe Novasep SAS. Groupe Novasep SAS and/or its affiliates (hereafter Groupe Novasep) own or license the copyrights, trademarks, names, logos, and other rights to the information in this brochure. No right or license is granted to any other losses for access or reliance and not from access. Any unauthorized use without the express prior written consent of Groupe Novasep is prohibited. Disclaimers: The information contained in this brochure are provided “as is”, for informational purposes only, without any representation or warranty of accuracy or completeness. In no event will Groupe Novasep be liable to any party for any damages or any other losses from access or reliance upon any information contained in this brochure.

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FRANCEGERMANY

BELGIUM

LUXEMBOURG

POMPEY STRASBOURG

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

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Services and technologies for the life science industries

Contact our experts: pharma@novasep.com