Services

Services, built on experience

From process to patient

Services

Services, built on experience

From process to patient

Beyond manufacturing, enabling market entry

A vaccine only protects when it reaches people. That takes reliable production, rigorous quality and the expertise to move from process to patient. For more than a century, we have done this with our own vaccines. Today, we bring that same experience, expertise and infrastructure to our partners.

Everything we offer partners is grounded in what we do ourselves. We manufacture, test, release, register and distribute vaccines to more than 140 countries. Our polio vaccines have helped protect over 100 million children, and our BCG has been used in more than five million bladder cancer treatments. Our partners have access to the same cell lines, facilities, quality systems and expertise we rely on every day.

From process to patient

Beyond manufacturing, enabling market entry

Our offerings

Our modular system lets you choose the modules you need. We offer the following modules.

Module 1: Drug substance

Production of viral vaccines and viral vectors, from infected cells to purified bulk.

Two cell platforms: Vero cells grown on microcarriers, and HEK293 cells in suspension
Bioreactor scale from 20 litres through 200 to 2,000 litres
Cell growth, virus infection, inactivation and harvest
Purification by clarification, anion-exchange chromatography and tangential flow filtration
Sterile filtration into single-use bags, with the bulk moved under cold chain

Module 2: Drug product

From formulation and aseptic filling to a labelled, supply-ready product.

Filling of 2R and 6R vials, with 10R and 20R as options: up to 70,000 vials a day
Filling of 1.1 mL prefilled syringes: up to 33,000 a day
Formulation in single-use systems, from 50 to 200 litres
Headspace gassing for oxygen-sensitive products
Visual inspection of every unit, labelling, and serialisation-ready lines

Module 3: Seed lots and cell banks

Well-characterised, securely stored cell banks and virus seeds for reliable vaccine manufacturing.

Production of master and working cell banks
Manufacture and banking of working virus seeds
Characterisation and a full release panel, together with specialised testing partners
Release of cell banks and seeds
Qualified storage from −180 °C to +20 °C

Module 4: Market entry

The quality, release and import services needed to bring your product to market in Europe.

Quality control testing and release: raw materials, in-process samples, microbiology, drug substance, drug product and stability
QP certification and batch release for clinical and commercial supply, also available on its own for products made elsewhere
Import of drug substance, investigational products and finished products into the EU
Handling of genetically modified organisms at ML-II, and at ML-III for adenoviral vectors at drug substance stage
Warehousing and distribution across Europe under Good Distribution Practice

Our offerings

Our modular system lets you choose the modules you need. We offer the following modules.

Module 1: Drug substance

Production of viral vaccines and viral vectors, from infected cells to purified bulk.

Two cell platforms: Vero cells grown on microcarriers, and HEK293 cells in suspension
Bioreactor scale from 20 litres through 200 to 2,000 litres
Cell growth, virus infection, inactivation and harvest
Purification by clarification, anion-exchange chromatography and tangential flow filtration
Sterile filtration into single-use bags, with the bulk moved under cold chain

Module 2: Drug product

From formulation and aseptic filling to a labelled, supply-ready product.

Filling of 2R and 6R vials, with 10R and 20R as options: up to 70,000 vials a day
Filling of 1.1 mL prefilled syringes: up to 33,000 a day
Formulation in single-use systems, from 50 to 200 litres
Headspace gassing for oxygen-sensitive products
Visual inspection of every unit, labelling, and serialisation-ready lines

Module 3: Seed lots and cell banks

Well-characterised, securely stored cell banks and virus seeds for reliable vaccine manufacturing.

Production of master and working cell banks
Manufacture and banking of working virus seeds
Characterisation and a full release panel, together with specialised testing partners
Release of cell banks and seeds
Qualified storage from −180 °C to +20 °C

Module 4: Market entry

The quality, release and import services needed to bring your product to market in Europe.

Quality control testing and release: raw materials, in-process samples, microbiology, drug substance, drug product and stability
QP certification and batch release for clinical and commercial supply, also available on its own for products made elsewhere
Import of drug substance, investigational products and finished products into the EU
Handling of genetically modified organisms at ML-II, and at ML-III for adenoviral vectors at drug substance stage
Warehousing and distribution across Europe under Good Distribution Practice

Our offerings

Our modular system lets you choose the modules you need. We offer the following modules.

Module 1: Drug substance

Production of viral vaccines and viral vectors, from infected cells to purified bulk.

Two cell platforms: Vero cells grown on microcarriers, and HEK293 cells in suspension
Bioreactor scale from 20 litres through 200 to 2,000 litres
Cell growth, virus infection, inactivation and harvest
Purification by clarification, anion-exchange chromatography and tangential flow filtration
Sterile filtration into single-use bags, with the bulk moved under cold chain

Module 2: Drug product

From formulation and aseptic filling to a labelled, supply-ready product.

Filling of 2R and 6R vials, with 10R and 20R as options: up to 70,000 vials a day
Filling of 1.1 mL prefilled syringes: up to 33,000 a day
Formulation in single-use systems, from 50 to 200 litres
Headspace gassing for oxygen-sensitive products
Visual inspection of every unit, labelling, and serialisation-ready lines

Module 3: Seed lots and cell banks

Well-characterised, securely stored cell banks and virus seeds for reliable vaccine manufacturing.

Production of master and working cell banks
Manufacture and banking of working virus seeds
Characterisation and a full release panel, together with specialised testing partners
Release of cell banks and seeds
Qualified storage from −180 °C to +20 °C

Module 4: Market entry

The quality, release and import services needed to bring your product to market in Europe.

Quality control testing and release: raw materials, in-process samples, microbiology, drug substance, drug product and stability
QP certification and batch release for clinical and commercial supply, also available on its own for products made elsewhere
Import of drug substance, investigational products and finished products into the EU
Handling of genetically modified organisms at ML-II, and at ML-III for adenoviral vectors at drug substance stage
Warehousing and distribution across Europe under Good Distribution Practice

Our offerings

Our modular system lets you choose the modules you need. We offer the following modules.

Module 1: Drug substance

Production of viral vaccines and viral vectors, from infected cells to purified bulk.

Two cell platforms: Vero cells grown on microcarriers, and HEK293 cells in suspension
Bioreactor scale from 20 litres through 200 to 2,000 litres
Cell growth, virus infection, inactivation and harvest
Purification by clarification, anion-exchange chromatography and tangential flow filtration
Sterile filtration into single-use bags, with the bulk moved under cold chain

Module 2: Drug product

From formulation and aseptic filling to a labelled, supply-ready product.

Filling of 2R and 6R vials, with 10R and 20R as options: up to 70,000 vials a day
Filling of 1.1 mL prefilled syringes: up to 33,000 a day
Formulation in single-use systems, from 50 to 200 litres
Headspace gassing for oxygen-sensitive products
Visual inspection of every unit, labelling, and serialisation-ready lines

Module 3: Seed lots and cell banks

Well-characterised, securely stored cell banks and virus seeds for reliable vaccine manufacturing.

Production of master and working cell banks
Manufacture and banking of working virus seeds
Characterisation and a full release panel, together with specialised testing partners
Release of cell banks and seeds
Qualified storage from −180 °C to +20 °C

Module 4: Market entry

The quality, release and import services needed to bring your product to market in Europe.

Quality control testing and release: raw materials, in-process samples, microbiology, drug substance, drug product and stability
QP certification and batch release for clinical and commercial supply, also available on its own for products made elsewhere
Import of drug substance, investigational products and finished products into the EU
Handling of genetically modified organisms at ML-II, and at ML-III for adenoviral vectors at drug substance stage
Warehousing and distribution across Europe under Good Distribution Practice

Interested in our services?

Please reach out to us and let’s explore how we could accelerate your project together

Our Projects

Supporting the European Union in their mission for self-sufficiency during future pandemics, we have developed an ever-warm multipupose facility dedicated to viral vector vaccines.

Partnership with VACSERA in Egypt for the manufacturing of Inactivated Polio Vaccines, thereby increasing accessibility to vaccines in Africa.

Our Projects

Supporting the European Union in their mission for self-sufficiency during future pandemics, we have developed an ever-warm multipupose facility dedicated to viral vector vaccines.

Partnership with VACSERA in Egypt for the manufacturing of Inactivated Polio Vaccines, thereby increasing accessibility to vaccines in Africa.

Our Projects

Supporting the European Union in their mission for self-sufficiency during future pandemics, we have developed an ever-warm multipupose facility dedicated to viral vector vaccines.

Partnership with VACSERA in Egypt for the manufacturing of Inactivated Polio Vaccines, thereby increasing accessibility to vaccines in Africa.

Our Projects

Supporting the European Union in their mission for self-sufficiency during future pandemics, we have developed an ever-warm multipupose facility dedicated to viral vector vaccines.

Partnership with VACSERA in Egypt for the manufacturing of Inactivated Polio Vaccines, thereby increasing accessibility to vaccines in Africa.

Over 100 years of expertise are ready to support your product development, from drug substance to market entry

Please send me the whitepaper

A successful project starts with getting the fundamentals right. Drawing on our experience, we have identified eight common pitfalls that can delay a technology transfer and how to avoid them.

Request our whitepaper Avoiding 8 Pitfalls in Tech Transfer to learn more:

Avoiding 8 Pitfalls in Tech Transfer whitepaper

How we work

Manufacturing a biologic is a long-term partnership. The people behind the process matter as much as the technology. Many of our specialists have spent years working with our platforms, facilities and products. That experience stays with your programme, from technology transfer through to commercial supply.

1
Start with a real conversation: Under confidentiality, we discuss your product, process, development stage and timelines. You engage directly with the technical specialists who could work on your programme.
2
Assess the fit: We assess your programme against our capabilities, capacity and experience. If we are not the right partner, we will tell you. Early clarity saves time for everyone.
3
Agree the pathway: Before work begins, we define scope, responsibilities, specifications and deliverables. Statements of Work, Project Charters, and Quality and Technical Agreements provide a clear framework for working together.
4
Deliver, together: From technology transfer and GMP manufacturing to QP certification, release and market access, we work as one team. We communicate openly throughout, especially when things do not go as planned.

Because successful partnerships depend on more than technology. They depend on experience, continuity and trust.

How we work

1
Start with a real conversation: Under confidentiality, we discuss your product, process, development stage and timelines. You engage directly with the technical specialists who could work on your programme.
2
Assess the fit: We assess your programme against our capabilities, capacity and experience. If we are not the right partner, we will tell you. Early clarity saves time for everyone.
3
Agree the pathway: Before work begins, we define scope, responsibilities, specifications and deliverables. Statements of Work, Project Charters, and Quality and Technical Agreements provide a clear framework for working together.
4
Deliver, together: From technology transfer and GMP manufacturing to QP certification, release and market access, we work as one team. We communicate openly throughout, especially when things do not go as planned.

Because successful partnerships depend on more than technology. They depend on experience, continuity and trust.

How we work

1
Start with a real conversation: Under confidentiality, we discuss your product, process, development stage and timelines. You engage directly with the technical specialists who could work on your programme.
2
Assess the fit: We assess your programme against our capabilities, capacity and experience. If we are not the right partner, we will tell you. Early clarity saves time for everyone.
3
Agree the pathway: Before work begins, we define scope, responsibilities, specifications and deliverables. Statements of Work, Project Charters, and Quality and Technical Agreements provide a clear framework for working together.
4
Deliver, together: From technology transfer and GMP manufacturing to QP certification, release and market access, we work as one team. We communicate openly throughout, especially when things do not go as planned.

Because successful partnerships depend on more than technology. They depend on experience, continuity and trust.

How we work

1
Start with a real conversation: Under confidentiality, we discuss your product, process, development stage and timelines. You engage directly with the technical specialists who could work on your programme.
2
Assess the fit: We assess your programme against our capabilities, capacity and experience. If we are not the right partner, we will tell you. Early clarity saves time for everyone.
3
Agree the pathway: Before work begins, we define scope, responsibilities, specifications and deliverables. Statements of Work, Project Charters, and Quality and Technical Agreements provide a clear framework for working together.
4
Deliver, together: From technology transfer and GMP manufacturing to QP certification, release and market access, we work as one team. We communicate openly throughout, especially when things do not go as planned.

Because successful partnerships depend on more than technology. They depend on experience, continuity and trust.

One module or the complete journey. The choice is yours.