Upstream Bioprocess Development Services

Privileged interaction creates unique relationships!

Novasep’s solid track record in manufacturing cGMP products helps to ensure programs are on time and to budget.

Upstream Services for the Development of your Biologics – our Offering

Experience with many expression systems

More than 50 microbial projects and 100 eukaryotic cell culture projects have led Novasep to manage process design, development and optimization through the perfect mastery and knowledge of cell behavior in a vast range of standard and custom conditions.

Broad knowledge of upstream technologies

Novasep has the ability to work in batch, fed-batch or perfusion mode (spin-filters, sonoperfusion, alternating tangential flow…) and generally performs two to three successive runs after optimization to ensure consistency.

A team committed to your project

Our goal is to accelerate your expression system’s program in a cost-effective and timely manner.

Through different steps, we develop, optimize and produce your biologics with important routine steps :

Technology Transfer

At Novasep, we consider technology transfer to be the most important part of any relationship with our client. Technology transfer consists of evaluating any data available from our client and the first technical interaction directly at their site.

Documentation transfer:

Once we’ve signed a Non-Disclosure Agreement, covering your interactions with Novasep and its worldwide subsidiaries, we assess the documents available on your side, including:

• Biosafety data and biological material, Biological MSDS (Material Safety Data Sheet)
• All process data available including scale, media, raw materials and parameters
• All lab-scale results available including yield, productivity, identity, purity, QC tests…

Biosafety evaluation/risk management:

Our first evaluation consists in carefully assessing the biosafety level of your project in order to evaluate biocontainment requirements and validation of decontamination methods.  Novasep is able to handle BL2 and BL3 (biosafety level 2, resp. 3) strains, thanks to e.g. specific flow and intercampaign procedures as well as suited pressure cascades . Our flexible multi-purpose facilities enable us to manage a number of parallel projects, and compel us to pay particular attention to any details regarding your biomaterial, biomolecule development stage and quantity requested.

Biological starting material details

In parallel to the quality and safety evaluation, we ask you to provide any details about the traceability on biological starting material. Proceeding in this way, we refer to our own quality policy and this guarantees the security of any manufactured product in our facility while protecting our own staff and minimizing any environmental risks.

Process understanding and technology transfer

Whenever possible, we visit your facility and meet your technical staff in order to witness the process in your specific environment. This step, lasting 2 to 4 weeks depending on your process complexity, is directly followed by the reproduction of your process in our facility under your supervision. This bridging activity ensures a perfect process reproduction at the same scale, enabling us to gain the necessary process know-how. This is the first milestone of our long-term relationship.
With Novasep as your partner, the technology transfer can be initiated from the clone to the late clinical large scale cGMP batches through the development, evaluation and validation of any part of your process.

Cell Line Development

Starting from plasmid DNA, Novasep is able to transfect the desired cell line, using the entire range of techniques available (electroporation, lipofectamine, fugene…) in order to create your own Development Cell Bank (DCB) after cell expansion.

We routinely work with almost every existing expression system:  mammalian cell lines, bacteria/yeast cell lines and insect cell lines. We can recommend the best expression system depending on your biopharmaceutical and particular process. 

We create and store genetically stable DCBs at our facility. Our experienced team ensures selection of clones suitable for manufacture showing high productivities, i.e. high producer clones. In addition we provide services of adaptation to serum-free/protein free media, recloning and media screening/optimization for your cell lines.

Analytical  Development

Our QC department routinely develops and validates our In-Process Control methods (IPC), characterization and release tests and manages outsourcing activities for specific QC tests.

We are able to develop and perform the following controls in-house:

IDENTITY

• ELISA
• Western-blot
• Genetic characterization via Southern-blot
• RT-PCR

QUANTITY

• Lowry
• µBCA
• Bradford
• UV spectrophotometry
• Liquid chromatography
• Sugar content via Anthrone assay
• HPLC

PURITY & PRODUCT RELATED IMPURITIES

• SDS-PAGE
• IEF
• Mycoplasma by ELISA

POTENCY

• In vivo Potency in mice
• In vitro Cytotoxicity assay
• Cell based assays

PROCESS RELATED IMPURITIES

• Residual DNA by Picogreen
• Residual Host Cell Proteins by ELISA
• Residual benzonase content

SPECIFIC TESTING FOR DRUG PRODUCT

• Sterility test via FTM and TSB
• Bacteriostatic and fungistatic validation
• Bioburden
• Visual appearance
• pH
• Osmolality
• Endotoxin content via LAL

Discover our:

• Services:
  • Bioprocess development for biologics
  • Contract biomanufacturing  for biologics
  • Customer services
• Range of biochromatography solutions
• Range of TFF solutions
• Quality Systems

Download our brochures for biologics manufacturing.

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