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Taking your viral vector manufacturing to commercial scale
Biopharmaceuticals

Taking your viral vector manufacturing to commercial scale

Novasep Viral Vector Commercial Manufacturing Infographic

Taking your viral vector manufacturing to commercial scale

The last 4 years have seen an increased number of clinical studies in both cell and gene therapies, carrying high hopes. 

The growing demand for targeted therapies creates high needs for specialized capacities.

If you are looking to outsource your viral vector commercial manufacturing to a reliable CDMO (Contract and Development Manufacturing Organization) partner, check out how Novasep can address all your needs.

Our viral experience

- 20 years of viral vector CDMO (Contract and Development Manufacturing Organization) experience

- 2 manufacturing sites in Belgium: Gosselies and Seneffe

- More than 100 cGMP batches produced and released in the last five years 

Our know-how:

- AAV vectors

- Lentivirus vectors

- Adenovirus vectors

- Other types of viral vectors: HSV (Herpes Simplex Virus), VSV (Vesicular Stomatitis Virus)

Therapeutic indications examples:

- Neuromuscular diseases

- Ocular diseases

- Hematologic diseases

- Cardiovascular diseases

- Cancer

Industrialization of your viral vector at Novasep

Process validation:

- Production process

   1. Characterization/Design

       - CQA (Critical Quality Attribute)

       - CPP (Critical Process Parameter)

       - CMA (Critical Material Attribute)

       - Preliminary Control Strategy

   2. Qualification

       - PVMP (Process Validation Master Plan)

       - Facility and equipment qualification

       - Validation studies

       - Final Control Strategy

       - PPQ (Process Performance Qualification) campaign 

   3. Continued process verification

- Analytical methods

   1. Qualification

   2. Validation

   3. Validated methods

Commercial manufacturing and release

Technology transfer

   1.Start

   2. Initiation

   3. Execution

   4. Completion

Our commercial capabilities

Senrise-IV for Drug Substance: commercial production facility for viral vectors

- 2 manufacturing lines

- Up to 2,000L

- Adherent and suspension modes

- Seneffe, Belgium

Senefill for Drug Product: commercial facility for aseptic Fill & Finish

- State-of-the-art facility

- Automatic filling

- Up to 10,000 vials per session

- Seneffe, Belgium

#messageinabottle

 

Want to learn more about our capabilities?

Download our brochure!

Downloads
  • AAV Vectors: finding the good in everyone
    AAV Vectors: finding the good in everyone
    Learn more about AAV Vectors and discover an exclusive case study about the manufacture of an AAV2 v...
    Download +
  • Lentivirus Vectors: finding the good in everyone
    Lentivirus Vectors: finding the good in everyone
    Learn more about Lentivirus Vectors and discover an exclusive case study about Lentivectors manufact...
    Download +
  • Other types of Viral Vectors (such as HSV)
    Other types of Viral Vectors (such as HSV)
    Discover an exclusive case study about Herpes Simplex Virus (HSV) manufacturing for cancer immunothe...
    Download +
  • Adenovirus Vectors: finding the good in everyone
    Adenovirus Vectors: finding the good in everyone
    Learn more about Adenovirus Vectors and discover an exclusive case study about the manufacture of an...
    Download +
  • Viral Vectors: finding the good in everyone
    Viral Vectors: finding the good in everyone
    Novasep is a reliable partner to support your clinical and commercial manufacture of viral vectors
    Download +
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