Bioproduction Markets and Applications

Vaccines:
human and veterinary

Injectable medicines:
Insulin
Anti-cancer agents
Anti-coagulants
…

Gene therapies

Cell therapies

Our customers

Our customers range from large groups to small organisations, with a variety of profiles:

Pharmaceutical groups
Biotechs
Research institutes
Sub-contractors (CMO / CDMO).

The major players in the pharmaceutical and biotech industries, renowned in their field, have placed their trust in us and can be found on our list of customer references.

A research centre

A development unit

A pilot site

A production unit

Our Single-Use solutions cover every stage of your production process.

Single-use technologies offer numerous advantages for the manufacture of biological products, both in the downstream and upstream processes and in the final formulation and filling stages. SUS can be installed at various points in the production process, not only optimising the production process but also increasing safety and guaranteeing the reliability of your products.

Discover our expertise

Upstream

Media preparation
Cell culture & Fermentation
Intermediate storage

Downstream

Purification
Buffer preparation
Sampling
Intermediate storage

Fill & Finish

Filling
Sampling

stages of the process in
bioproduction

Upstream Process

The Upstream Process in biomanufacturing refers to all the preliminary stages required for the culture and growth of cells, which produce the desired biomolecules of interest (proteins, antibodies, vaccines, etc.). This process includes key stages such as the development of cell banks, cell amplification and culture in bioreactors.

Media preparation : the culture medium is carefully optimised to provide the nutrients, vitamins and growth hormones required by the cells.
Fermentation: fermentation, often carried out in stirred or perfused bioreactors, enables laboratory production to be scaled up to industrial scale, maximising cell growth.
Cell culture: the cells are then grown in bioreactors, where parameters such as pH, temperature and oxygenation are rigorously controlled to ensure optimum production.
Harvesting: Once the cells are ready to be harvested, they are separated from the culture broth and extracted, taking care to remove impurities and avoid contamination, using filtration techniques.

The Upstream Process is crucial, as it is the first phase of production and directly determines the quality and yield of the biomolecules.

Downstream Process

The Downstream Process in biomanufacturing involves the purification and treatment of the biomolecules produced during the Upstream Process. These stages are essential for isolating, purifying and formulating the final product, whether therapeutic proteins, monoclonal antibodies or vaccines. It is at this stage that the raw materials are transformed into an ultra-pure product, guaranteeing optimum safety.

Clarification: this critical stage removes cell debris from the culture broth and other impurities, using centrifugation, filtration or other separation techniques.
Capture: this process consists of isolating the target biomolecule from the complex mixture resulting from the Upstream phase.
Refined purification: this phase aims to separate the target product from impurities by eliminating contaminants (foreign proteins, residual DNA, endotoxins).
Concentration: the purified product is often diluted during purification. To remedy this, the volume of the liquid containing the biomolecule of interest is reduced in order to increase its concentration. This increases the product’s potency and optimises its purity.

This process is crucial for guaranteeing the quality, safety and efficacy of biopharmaceutical products. Insufficient purification could lead to contamination or reduced biological activity, putting patients at risk and compromising regulatory approval.

Fill & Finish Process

This final stage involves the final preparation of the product in a form suitable for its therapeutic use.

Formulation : the purified active substance from the Downstream Process is mixed with specific excipients to create a stable, effective pharmaceutical form suitable for administration to the patient.
Filling: the purified and formulated biopharmaceutical product is filled into its final container (vials, syringes, cartridges, etc.).
Packaging : finally, the finished biopharmaceutical products are packaged and labelled to prepare them for storage, transport and distribution.

This step is essential to preserve the integrity and effectiveness of the product, while complying with the strict standards of the biopharmaceutical sector. Fill & Finish is a guarantee that medicines are ready to be used safely by patients, while meeting quality and traceability requirements.

Examples of products by application

Our products, as well as our custom Single-Use assemblies, cover a wide range of applications.

Harvesting
Addition
Sampling
Filling
Tank transfer
Bulk transfer
Filtration
Transport with storage
Use of peristaltic pumps
Cleaning
Sterilisation…

FAQ

Our applications

a

In which sectors are Aseptic Group’s single-use solutions used?

We mainly meet the needs of the biopharmaceutical and biotechnology industries, in particular :

Production of human and veterinary vaccines.
Manufacture of injectable medicines.
Gene and celltherapies.
Any other manufacturing process requiring a high level of sterility and efficiency.

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What are the downstream stages and what are the benefits of SUS for these stages?

The Downstream process includes the purification and recovery of the biological product after cell culture. This involves stages such as clarification, filtration and chromatography. SUS plays a key role here by offering :

Significantly reduced downtime thanks to rapid installation.
Space-saving: the SUS are designed to optimise space in production facilities.
Reduced environmental impact thanks to well-defined waste management options.
Compatibility with modern filtration systems, such as tangential or depth filtration, for effective purification.

These solutions enable a rapid transition from one production campaign to another, increasing the overall efficiency of operations.

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What is the fill-and-finish process and how do single-use solutions come into play?

Fill-and-finish corresponds to the final stages of the bioproduction process, where the product is packaged in its final containers (syringes, vials or pouches).

Single-use technologies offer advantages such as :

Sterile processes guaranteed thanks to pre-sterilised components.
Reducing the risk of contamination by minimising handling and using closed systems.
Shorter set-up times: the systems are ready to be integrated directly into the filling lines.
Adaptability: suitable for different formats and volumes to meet the specific needs of bioproducts.

This is particularly valuable for high added-value organic products with limited production volumes.

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What is the Upstream process and how do single-use technologies contribute to it?

The upstream biomanufacturing process involves growing and multiplying cells in bioreactors to produce the desired biological product. Single-use technologies (Single-Use Systems or SUS) offer a number of advantages:

Reduced cross-contamination thanks to dedicated, sterile equipment.
Greater flexibility: they facilitate frequent changes between batches and adapt to different production volumes.
Cleaning costs eliminated, as equipment is disposed of after use.
Quick to install: the systems are pre-sterilised and ready to use.

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Which applications can benefit from single-use solutions?

Aseptic Group’s Single-Use systems are ideal for many sectors, including biopharmaceuticals and biotechnology, and can be used for a wide range of applications: