Upstream Biomanufacturing Services for Fermentation and Cell Culture Products

A partner to address your manufacturing challenges of today and tomorrow

With Novasep, you benefit from a vertical contract manufacturing solution for upstream including cell banking, fermentation and cell culture.

Our multipurpose production facilities are designed according to European and US regulatory requirements, where they support and segregate different manufacturing processes simultaneously. This gives us the right balance between control and flexibility to produce your biologics in a time efficient and cost-effective manner.

Contracting the Manufacture of your Biologicals – your Benefits

A devoted partner for your biopharmaceutical manufacturing

More than 60 biopharmaceutical companies and academic institutes have trusted us and perpetuate their relationship with us for the development of their pipeline through the different clinical phases. We have longstanding relationships with Oxford Biomedica, Wyeth vaccines, Genticel, Profectus, GlaxoSmithKline Biologicals, HanAll, Pasteur Institute of Paris, Pasteur Institute of Lille, European Vaccine Iniative, LFB, among others…

We have expertise in organizing clinical trials and writing regulatory documents (e.g. CMC part of IMPD/IND files) as well as in-house expertise and qualification in immunology (e.g. potency testing for vaccines, binding assays,…)

We team up with you for your biopharmaceutical manufacturing

Under a mutual confidentiality agreement, we include one member of your team in the project management and execution. This is a valuable asset for your company when going from
lab scale to pilot and large-scale production for phase III clinical studies.
We are dedicated to being your partner to speed up your product development while minimizing your investment risk.

A certified partner for your biopharmaceutical manufacturing

With Novasep, you have access to all required services, including the delivery of a complete file covering the manufacturing procedures of your clinical grade biomolecules.
See our complete offering for biomolecule manufacturing.

Upstream Manufacturing Services – Our Offering

Cell Banking

We routinely perform banking of bacteria, yeast, eukaryotic cell lines and viruses, and have expertise in Master Cell Bank (MCB), Working Cell Bank (WCB), Master Virus Seed Stock (MVSS) and Working Virus Seed Stock (WVSS) production (up to 350 cryovials) and management, storage in our facilities (with 2 separate cryogenic storage locations).

This starting material is the first step of our cGMP biomanufacturing service and allows us to initiate your cGMP compliant process.

Analytical support

Through our quality team, we manage all analytical tests for biopharmaceuticals . To see our complete offering, click here.

We have also a wide subcontractor network able to perform the entire panel of specific quality control testing. We propose a real turnkey package, challenging various partners to offer you the best price, managing all external activities and managing stability studies in-house for your biopharmaceutical.

Our scope of services include biopharmaceutical production scale-up.

Our biopharmaceutical production scale-up services help you provide the required quantity for your preclinical and clinical studies while adapting the lot size to offer you the best cost per unit and choosing a process perfectly adapted to industrial scale.

With regards to USP, we guarantee consistent cell behaviour all the way through to large scale, to ensure the best results at final scale and to meet your required biologic quantity and quality.
For cell culture, we offer a working volume capacity of up to 250 L (stainless steel). While for fermentation, we offer a capacity of up to 100 L working volume. For these scales or above, we have implemented biodisposable solutions with a specific bioreactor of your choice.

Our Capacities

Our state-of-the art, upstream process development and multi-purpose biomanufacturing facilities have the following features:

• 900 m² of clean rooms with 10 cGMP Class C suites (including 3 BSL3 and 7 BSL2 suites, with three 4°C rooms for purification) and 3 full aseptic suites dedicated to sterile processes and/or fill and finish activities
• All necessary cGMP logistics suites (for media and buffer preparation weighing, etc…)
• All necessary utilities including WFI production on both sites
• Process development labs
• Approx. 500 m² of QC laboratories with all routine biochemical, microbiological and immunological analytical technologies
  Storage rooms for raw material, intermediate and final products

The equipment includes:

• 25 bioreactors and fermentors from 3 L to 250 L
• Multiple biochromatography and filtration systems, incubators, etc.
• 50L to 1000L single-use bioreactors

A Partner for Antibody-Drug Conjugate (ADC) Development and Manufacturing

Novasep offers a complete strategy for the manufacturing of ADCs, from early development to commercial scale. MAb production, the mAb-toxin conjugation and final purification is carried out at the site in Seneffe, Belgium and the synthesis of the highly potent toxin is performed at the Le Mans site in France which was recently upgraded.

This site is FDA inspected and its excellence in the safe handling of very toxic compounds was recently recognized  through SafeBridge® certification.

Download our brochures for biologics manufacturing.

For any question on Novasep's manufacturing services and equipment for biologics, please contact us.