Increasing accessibility by accelerating vaccine development
Building services for a healthier worldIncreasing accessibility by accelerating vaccine development
Building services for a healthier worldServices
Born from a legacy of service and rooted in more than a century of vaccine expertise, Bilthoven Biologicals has supported public health through reliable access to essential vaccines. But we’re not here to preserve history. We’re here to shape what’s next, using the experience we’ve built over decades. We believe that through sharing of knowledge we can accelerate vaccine development. And we are willing to share our knowledge with you.
Services
Born from a legacy of service and rooted in more than a century of vaccine expertise, Bilthoven Biologicals has supported public health through reliable access to essential vaccines. But we’re not here to preserve history. We’re here to shape what’s next, using the experience we’ve built over decades. We believe that through sharing of knowledge we can accelerate vaccine development. And we are willing to share our knowledge with you.
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.
From process development to commercialisation, over 100 years of expertise are ready to support your vaccine services
Our offerings
CDMO ActivitiesWe can support you in
- Process development
- Clinical scale manufacturing of biopharmaceuticals
- Commercial scale manufacturing up to 2000L under BSL 2/3 conditions
Services for Investigational Medicinal Product (IMP)- Physical importation of intermediate or IMP (biological, biotechnical and/or medicinal products for immunological use)
- QC testing
- IMPD review
- Batch certification and release for clinical trials.
- Shipment to clinical sites
Our offerings
CDMO ActivitiesWe can support you in
- Process development
- Clinical scale manufacturing of biopharmaceuticals
- Commercial scale manufacturing up to 2000L under BSL 2/3 conditions
Services for Investigational Medicinal Product (IMP)- Physical importation of intermediate or IMP (biological, biotechnical and/or medicinal products for immunological use)
- QC testing
- IMPD review
- Batch certification and release for clinical trials.
- Shipment to clinical sites
Our offerings
CDMO ActivitiesWe can support you in
- Process development
- Clinical scale manufacturing of biopharmaceuticals
- Commercial scale manufacturing up to 2000L under BSL 2/3 conditions
Services for Investigational Medicinal Product (IMP)- Physical importation of intermediate or IMP (biological, biotechnical and/or medicinal products for immunological use)
- QC testing
- IMPD review
- Batch certification and release for clinical trials.
- Shipment to clinical sites
Our offerings
CDMO ActivitiesWe can support you in
- Process development
- Clinical scale manufacturing of biopharmaceuticals
- Commercial scale manufacturing up to 2000L under BSL 2/3 conditions
Services for Investigational Medicinal Product (IMP)- Physical importation of intermediate or IMP (biological, biotechnical and/or medicinal products for immunological use)
- QC testing
- IMPD review
- Batch certification and release for clinical trials.
- Shipment to clinical sites
Interested in our services?
Please reach out to us and let’s explore how we could accelerate your project together
Regulatory Compliance
Adhering to the highest standards for clinical trial and service operations
Quality System
Documented processes and procedures for IMP manufacturing, testing and distribution within our comprehensive quality system.
EU Compliance
Regular IMP release for European clinical studies according to Annex 13 and EU Clinical Trial Regulation.
BSL 2/3 Facility
State-of-the-art biosafety level 2/3 conditions ensuring the highest safety and quality standards for manufacturing.
Regulatory Compliance
Adhering to the highest standards for clinical trial and service operations
Quality System
Documented processes and procedures for IMP manufacturing, testing and distribution within our comprehensive quality system.
EU Compliance
Regular IMP release for European clinical studies according to Annex 13 and EU Clinical Trial Regulation.
BSL 2/3 Facility
State-of-the-art biosafety level 2/3 conditions ensuring the highest safety and quality standards for manufacturing.
Accreditations & Certifications
Our accreditations and certifications demonstrate our commitment to quality and compliance
- Marketing Authorization Holder (IPV, Tetanus vaccine, DT-IPV)
- BSL 2&3 certified production and laboratory facilities
- MIA for biological production, production of clinical materials and import of clinical trial materials
Good Manufacturing Practise
Good Distribution Practise
ISO 9001 (recertified 2022)- ISO 14001 (recertified 2022)
Accreditations & Certifications
Our accreditations and certifications demonstrate our commitment to quality and compliance
- Marketing Authorization Holder (IPV, Tetanus vaccine, DT-IPV)
- BSL 2&3 certified production and laboratory facilities
- MIA for biological production, production of clinical materials and import of clinical trial materials
- Good Manufacturing Practise
- Good Distribution Practise
- ISO 9001 (recertified 2022)
- ISO 14001 (recertified 2022)
Accreditations & Certifications
Our accreditations and certifications demonstrate our commitment to quality and compliance
- Marketing Authorization Holder (IPV, Tetanus vaccine, DT-IPV)
- BSL 2&3 certified production and laboratory facilities
- MIA for biological production, production of clinical materials and import of clinical trial materials
- Good Manufacturing Practise
- Good Distribution Practise
- ISO 9001 (recertified 2022)
- ISO 14001 (recertified 2022)
Accreditations & Certifications
Our accreditations and certifications demonstrate our commitment to quality and compliance
- Marketing Authorization Holder (IPV, Tetanus vaccine, DT-IPV)
- BSL 2&3 certified production and laboratory facilities
- MIA for biological production, production of clinical materials and import of clinical trial materials
- Good Manufacturing Practise
- Good Distribution Practise
- ISO 9001 (recertified 2022)
- ISO 14001 (recertified 2022)