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CMO Services for Viruses & Viral Vectors
Biopharmaceuticals

CMO Services for Viruses & Viral Vectors

Bdbioph2

A complete outsourcing solution

For more than 15 years, Novasep has aquired experience in manufacturing attenuated or wild type viruses and viral vectors. Our track record includes:Novasep VERO Cells On Microcarrier CMO Virus

  • Gene and cancer therapies,
  • Vectorized vaccines,
  • Live or killed viral vaccines,
  • Virus-like particles
  • Rec-proteins expression (e.g. via baculovirus/insect cells)

Novasep offers a full range of services adapted to your needs, from L1 up to L3 containment levels, including:

  • 6 R&D labs and 10 cGMP suites designed for the containment of BSL2/BSL3 pathogens
  • A clear methodology for technical and analytical methods transfer
  • Full USP and DSP capabilities from process development up to clinical trial material manufacturing
  • A broad expertise in single-use and reusable technologies for culture and purification
  • Full analytical development and qualification (including virus-specific potency, identity and transgene expression assays such as TCID50, IFA and qPCR)

 

An efficient methodology for virus and viral vector manufacturing

We can address all manufacturing needs thanks to a strong mastery of both cultivation and purification technologies as well as virus-dedicated process development methodology:

  • Full process and analytical transfer
  • Upstream process development
    • Cell line adaptation to serum-free, suspension growth
    • Development Cell & Virus Banks
    • Cell culture development (parameters, feeding strategy…)
    • Single-use and stainless steel bioreactors: from 3 to 1,000 L
    • Viral infection and viral DNA transfection procedure development
    • Lysis conditions development
  • Downstream process development
    • Clarification development
    • Development of purification steps (filtration and chromatography)
    • Development of virus inactivation
  • Process scale-up
  • cGMP material production
    • Cell Banks (MCB, WCB), Virus Seeds (MVS, WVS) and Drug Substance
  • Process validation

 

Specific know-how in AAV, ADV and lentiviruses …

Novasep has a strong track record and focus on AAV, ADV and Lentiviruses because of their attractive features for gene therapy or vaccination:

  • Lentiviruses (e.g HIV, EIAV) can stably transfer therapeutic genes into both dividing and non-dividing cells. They represent a tool of choice for long-term expression, especially for the treatment of genetic diseases.
  • Adenoviruses advantages are numerous: high transduction efficiency, high level of transgene expression, large tropism. ADV can transiently infect both dividing and non-dividing cells.
  • Adeno-Associated Viruses are non-pathogenic. AAV are able to mediate long-term gene expression for correcting genetic or acquired diseases. The numerous pseudotypes currently available allow them to transduce a large variety of target tissue types.

 

…and many other viruses and viral vectors

Each virus family exhibits specific properties such as: structural diversity, infectivity, pathogenicity and degree of resistance to physical-chemical treatments. Consequently, viral vector production can be very challenging. Therefore, our solid CMO track record will be instrumental in bringing your project to success:

Type Family Production System Application Maximum
Scale
Lentiviral vectors

Retroviridae

EIAV/HIV-1

HEK-293T cells

Static

Gene Therapy

Clinical trials

25 CF10

15HS36

Venezuelian Equine Encephalitis-derived replicon particles Togoviridae

VERO cells

Static

Vaccination

Clinical trials

24 T150

Highly attenuated recombinant VSV Rhabdoviridae

VERO cells

Microcarrier/BR

Vaccination

Clinical trials

10L SUB

Recombinant Measles Virus Paramyxoviridae

MRC5

Static

Aseptic process

Vaccination

Clinical trials

24 CF10

Attenuated Influenza Virus (A&B) Orthomyxoviridae

VERO cells

Static

Vaccination

Clinical trials

15 CF10

Recombinant attenuated Dengue Virus Flaviviridae

VERO cells

Microcarrier/BR

Vaccination

Pre-clinical

50L SUB

H-1 virus Parvoviridae

Human T-cells

Wave BR

Cancer Therapy

R&D

25L SUB

Baculovirus vectors encoding for VLP Baculoviridae

Sf9 or Hi-5

BR

Vaccination


Immunotherapy

Clinical trials

50L SUB

Baculovirus vectors encoding for recombinant proteins
Downloads
  • Global offer for biopharmaceuticals
    Global offer for biopharmaceuticals
    size: 140.8K
    date: 08/12/2014
  • Viral vector and virus manufacturing services
    Viral vector and virus manufacturing services
    size: 2.3M
    date: 08/12/2014
  • ADC Brochure
    ADC Brochure
    size: 672.1K
    date: 20/10/2015
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