CDMO SERVICES
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Rutger

Rutger Vandiest

Sr. Director - Head of Sales, CDMO
Bavarian Nordic

cdmo@bavarian-nordic.com+32 46 804 66 86
Who we are

A unique full-service biotech partner
for innovation and manufacturing of
GMO2/ BSL2 sterile liquid and
lyophilized products

WHAT WE CAN DO FOR YOU

We’re vaccine experts &
innovators who offer a wide
range of services

As innovators and developers of live virus vaccines, we are fully aware of the complexities and risks to getting product to market under the strictest of regulations. Our combination of expertise, state-of-the-art facility and technology, can guide and accelerate your biological therapeutics from pre-clinical to commercial stage and beyond while delivering the highest quality and reliable sterile products that improve the health and quality of life for children and adults.

DEVELOPMENT
Live Virus manufacturing
DRUG SUBSTANCE
Drug product
SUPPORT SERVICES

Process development Formulation development Analytical development

Any drug development process must proceed through several stages in order to produce a product that is safe, efficacious, and has passed all regulatory requirements. Our scientists will assist you through all stages of CMC development and will help you to determine your testing needs. Our experienced staff can perform the critical tests and studies that are necessary to achieve regulatory approval.

Master seed virus Working seed virus

Our virus seed-banking processes and the BSL2 facility we use to manufacture your virus seed stocks are fully GMP compliant and offer high quality, stable and fully traceable starting material for GMP manufacturing of clinical and commercial products.

Pilot plant scale - Non GMP Clinical and commercial scale - GMP

Our talented people, well thought-through processes and comprehensive, validated equipment have been utilized in our BSL2 classified facility to fulfill numerous drug substance projects for preclinical, clinical and commercial supply.

Current Fill & Finish 2020 Fill & Finish

Today Bavarian Nordic offers fill and finish services using innovative technologies that are specifically designed to protect your biologic’s integrity and optimize yield of costly drug product. With a wealth of experience dealing with biologics, our scientists provide expertise across all areas of parenteral formulation and sterile manufacturing. By 2020 we will also provide large scale manufacturing, lyophilization and an integrated packaging line with serialization in our new fill and finish facility.

Quality Project management

We value the importance of product quality and compliance: Our objective is to be sure your product supply does not become the rate-limiting step for its overall development. Working with you from early stages of development to commercial scale/production, we will ensure that your product is of high quality and reaches your patients on time.

WHAT WE OFFER

Highlights of our currently
available fill and finish services
and looking ahead to 2020

Speaking as one biotech company to another, we appreciate the complexities of product development and manufacturing. By expanding our clinical and small scale commercial capabilities to a full commercial fill and finish facility with dedicated customer capacity, we will support you even further in bringing your valued products to your patients.

F&F Today
Clinical & small scale manufacturing
Formulation, Filtration, Aseptic filling, Visual inspection, Labeling, Packaging, Stability testing.
F&F Today
Automated filling line
Automated filling and capping, Closed RABS system, DIN2R vials and others, Batch size up to 10,000 vials, Line output 1,000 vials per hour, Automated IPC, Peristaltic pumps.
F&F Today
Vial labeling & packaging
Manual & Semi-automated for small scale commercial volumes.
F&F 2020
Isolator filling line
Bosch filling line with isolator and capping line in cRABS. Peristaltic pumps and single-use product contact parts.
F&F 2020
Large scale lyophilization
IMA lyophilizer 40m², 15 shelves- Fully automated loading/unloading within isolator protection, Liquid nitrogen cooled, Tempris product temperature monitoring system.
F&F 2020
Integrated label & packaging line
Bosch integrated high-speed labeling and packaging line for single- and multidose packs. The packaging line is built with full serialization and aggregation capabilities.

Download detailed
service brochure

Why cdmo

“ Why CDMO? With 25 years of experience in R&D,
manufacturing and registration of live
virus vaccine products it’s about time
to expand our areas of business. ”

Henrik Birk
EVP, COO, Bavarian Nordic

3 REASONS TO CONTRACT WITH US

Why you should
consider us as your
trusted partner

01

EXPERTISE
& KNOWLEDGE

We´re experts working with live viruses and vaccines from discovery to development to manufacturing both for clinical and market supplies. Our reputation as a leading global vaccines provider is built on long-term collaborative relationships with government agencies and top-tier industry partners.

02

IN IT FOR
THE LONG RUN

As innovators and developers of live virus vaccines, we’re passionate about tackling diseases that really burden people’s lives. We have vaccines in clinical testing against a variety of advanced cancers and in serious infectious diseases.

03

READY TO
START TODAY

We’re invested in bringing our expertise, knowledge and passion to work for you by offering CDMO capabilities and services already today. By 2020 we also have a new large scale fill and finish facility where we can offer expanded BSL2 and lyophilization capacity.

DID YOU KNOW?
0%
of our 450 employees hold a Ph.D.
Come visit us at
Visit event

CPHI NORTH-AMERICA

April 30-May 2nd, 2019
McCormick Place - Chicago, Illinois
Visit us at booth 418

CPhI Worldwide

5-7th November 2019
Frankfurt, Germany
Visit us at booth 121G74

A global biotech company

We are a global
biotech company &
service provider

Bavarian Nordic is a global, fully vertically integrated biotechnology company focused on the research, development, manufacturing and marketing of innovative and safer vector-based vaccines against cancer and infectious diseases. Our goal is to improve the health and quality of life for children and adults, focusing on indications for which the unmet medical need is high and for which we can harness the power of the immune system to induce a response.

Denmark

Bavarian Nordic
Headquarter & Manufacturing
Hejreskovvej 10A
DK-3490 Kvistgaard,
Denmark

USA

Bavarian Nordic
Clinical Development
3025 Carrington Mill Boulevard
Morrisville NC 27560
USA

Germany

Bavarian Nordic
Research & Development
Fraunhoferstrasse 13
D-82152 Martinsried
Germany

Bavarian Nordic CDMO

The complex made simple

 

cdmo@bavarian-nordic.com

+32 46 804 66 86

Learn more about us
bavarian-nordic.com

We are always looking
for bright new talent.
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