Biologics
Strategies

BIOLOGICS STRATEGIES

DEVELOPING THE RIGHT PRODUCT

We have developed two manufacturing platforms, both implementing disruptive innovations resulting in a cost-effective manufacturing of biologics. Viral vaccines production requires a fixed bed for adherent cells culture, such as VERO and MRC5, while proteins production is based on non-adherent cells culture, such as CHO and NS0.

  • Viral vaccines platform

Univercells’ viral vaccines production platform is based on a disruptive setup, with improvements introduced at each step of the manufacturing process. We developed an intensified process operated in perfusion, allowing in-line clarification followed by a continuous-sequential capture on small affinity chromatography columns.

This innovative process is automated and continuous, and can do without intermediate storage tanks, therefore significantly reducing the footprint of the equipment.

  • Proteins platform

Univercells has developed manufacturing processes implementing single-use cost-effective bioreactors operated in fed-batch or perfusion modes, with in-line clarification & capture operated in simulated continuous mode. This allows to operate on a 24/7 basis and treat the harvests of several bioreactors, followed by continuous feeding of capture on small affinity chromatography columns.

The results is an adaptive platform able to produce a broad portfolio of proteins, such as biosimilar antibodies and therapeutic enzymes.

 

WHAT TYPE(S) OF BIOLOGICS HAVE YOU EXPERIENCE WITH?

Univercells has experience with a wide variety of cell lines and biologics. Our leading scientists have actively participated in the development of several industrial processes for vaccines, both human and veterinary, and recombinant proteins including monoclonal antibodies and enzymes. Our large expertise of the field allowed us to develop robust and validated processes which will allow us to fast-track your biomanufacturing process development and industrialization.

Technology & Process Design

TECHNOLOGY & PROCESS DESIGN

UNIVERCELLS STRONG EXPERTISE

The process of biomanufacturing has evolved over the years:

For a long time, stainless steel large-scale facilities have been used for industrial manufacturing of biologics. Those facilities are very expensive, and not flexible.

In recent years, single-use technologies have led to more flexible facilities, allowing lower investment and production cost. However, the scalability of those single-use solutions is limited and not adapted to large-scale production.

At Univercells, we are on a mission to change this paradigm by completely re-inventing the manufacturing process, using:

  • Fixed-bed Bioreactor operated in perfusion to achieve high cell density (50-70% volume reduction)
  • Chaining to clarification & capture operations
  • Resulting in a continuous production line from USP do DSP

This approach enables to setup simplified production units in record time.

Univercells’ solution offers significantly lower investment costs, high-flexibility, and high productivity (up to 500kg/year of mAbs or 40 million doses of vaccines).

Based on this innovative process design, Univercells’ endeavors to adapt its offer to create a tailored solution for each partner: Univercells can provide a full process development package, including tech transfer, but can also adapt its innovative approach to partial or existing processes.

 

WHAT TECHNOLOGY ARE YOU USING & ARE YOU LIMITED TO SPECIFIC TECHNOLOGIES?

We strongly believe in technology-driven availability and affordability. From upstream to downstream, we are fully independent in the selection of the technologies. We only implement the most efficient and adapted ones, paying special attention to their user-friendliness, ease-of-integration and support services package.

Technology Transfer &
Training

TECHNOLOGY TRANSFER & TRAINING

EMPOWERING LEADERS.

Univercells is on a mission to make biologics more affordable, and this will only be made possible if emerging countries are allowed to produce high-quality biologics in-country, for-country. Univercells is therefore putting a strong emphasis on training and technology transfer, as our final goal is to enable our partners to become autonomous.

In addition, collaboration with local universities or research centers are strongly encouraged, through PhD programs combined with Belgian Universities.

 

DO YOU ALWAYS DEVELOP NEW FACILITIES FROM SCRATCH OR CAN YOU EXTEND FACILITIES?

Customer first! Our mission is to adapt our solutions to the needs and requirements of our customers. We have the expertise and the partners to develop projects from scratch or to integrate new capabilities in existing facilities.

GMP
Facility Building & Operation

GMP FACILITY BUILDING & OPERATION

SMALLER FOOTPRINT. LARGER OUTPUT.

When optimized and validated, processes can rapidly be transferred and implemented in a small and simplified cGMP manufacturing facility designed by our experts. When it comes to biomanufacturing, Univercells approach is to keep the highest degree of flexibility, with modular and scalable facilities.

Ultimately, we develop long term and optimal supply chain strategies where technologies implemented are selected and validated after strong suppliers audit and by applying double sourcing strategy.

 

DO YOU ALWAYS DEVELOP NEW FACILITIES FROM SCRATCH OR CAN YOU EXTEND FACILITIES?

Customer first! Our mission is to adapt our solutions to the needs and requirements of our customers. We have the expertise and the partners to develop projects from scratch or to integrate new capabilities in existing facilities.

API Manufacturing Support

API MANUFACTURING SUPPORT

ACCESS TO THE MARKET. FAST AND SAFE.

To accelerate your access to the market, Univercells relies on privileged partnerships with CMOs to develop and produce bulks of Active Pharmaceutical Ingredients intended for clinical trials or commercial sales, therefore decreasing your investment risks ahead of the Marketing authorization of your product.

 

WHAT TYPE(S) OF BIOLOGICS HAVE YOU EXPERIENCE WITH?

Univercells has experience with a wide variety of cell lines and biologics. Our leading scientists have actively participated in the development of several industrial processes for vaccines, both human and veterinary, and recombinant proteins including monoclonal antibodies and enzymes. Our large expertise of the field allowed us to develop robust and validated processes which will allow us to fast-track your biomanufacturing process development and industrialization.