Novasep is one of the rare CMOs throughout the world able to handle BSL3 pathogens under cGMP conditions; from process development to commercial production including upstream and downstream operations.
This unique capability perfectly combines with our viruses and viral vectors manufacturing services and recombinant proteins manufacturing services.
WHEN DO YOU NEED A L3 FACILITY?
A L3 or P3 facility, especially at industrial-scale, can be required for multiple projects. Some examples:
- Production of a micro-organism (virus, bacteria, etc.) classified as BSL3
- Large-scale manufacturing of a BSL2 pathogen
- Production of BSL2 organism expressing hazardous compounds or toxins
- Production of viral vectors with risk of recombination generating pathogenic wild type-like viruses
- Purification of antigenic fragments of a BSL3 pathogens for sub-unit vaccines
- Production and purification of BSL3 pathogen extracts used as adjuvant
UNIQUE CAPABILITIES AND METHODOLOGY
With a strong expertise in virus production and bacteria manufacturing, we have the methodology required to bring your project to success:
- Full process transfer
- Upstream process development:
- Creation of Master Seed Virus (MSV) and Working Seed Virus (WSV)
- Creation of Master Cell Bank (MCB) and Working Cell Bank (WCB)
- Optimization of cell culture and fermentation parameters (feeding strategy…)
- Viral infection and viral DNA transfection procedure optimization
- Optimization of the expression induction
- Lysis conditions optimization
- Downstream process development
- Clarification optimization
- Optimization of purification steps (filtration and chromatography operations)
- Virus inactivation conditions
- Process scale-up and validation
- Full analytical transfer, development and qualification
Our unique, dedicated R&D laboratory for BSL3 pathogens handling is perfect for technical transfer, pilot-scale studies and streamlined process development to cGMP operations.
PROTECTING OUR PEOPLE, PROTECTING OUR ENVIRONMENT
As the safety of our employees is the most valuable thing at Novasep, our employees received a specific training to handle BSL3 pathogens. We implemented a strict health surveillance program as well as prophylactic and therapeutic measures, depending on the micro-organism.
These measures are completed by strict and well-defined procedures for project preparation, manufacturing stages, waste decontamination and elimination, and in case of emergency.
Our waste management and facility decontamination policies are supported by clear validation studies and are checked on an annual basis.
CAPACITIES AND FACILITIES
R&D and pilot scale lab fully dedicated to BSL3 handling: 40 m²
cGMP production suites dedicated to BSL3 manufacturing: 4 suites, 80 m² Process development labs and offices: 3,000 m² QC labs: 300 m²
|Cell culture||Up to 200 L for cGMP production|
|Fermentation||Up to 100 L for cGMP production|
|Cultiation modes||Static, micro-carriers, suspension|
|Cultivation processes||Batch, fed-batch, perfusion|
|Mammalian expression systems||VERO, HEK, CHO, MRC-5, SP2/0, proprietary cell lines, etc.|
|Bacteria and yeasts||E.coli, Staphylococcus, Shigella, V.cholera, Lactococcus lactis, etc.|
|Chromatography||Batch, from 10 to 300 mm I.D.
Resin and membrane
|Filtration||TFF units for MF and UF/DF|
OUR TRACK RECORD
We already have an important track record of development and production in the followings: large-volume of HIV, Venezuelan Equine Encephalitis Virus (VEEV), Neisseria, etc.