Contract GXP Services

Statens Serum Institut (SSI) has more than 100 years of experience in research, development and manufacturing of biopharmaceuticals. Vaccine Development have produced more than 20 biopharmaceuticals and contributed to more than 30 clinical trials the last 15 years.

Updated 27 October 2026

The Vaccine Development Department (VUA) at Statens Serum Institut (SSI) has more than 25 years of experience in advancing vaccine candidates from early research towards first-in-human (FIH) clinical trials.

We offer integrated expertise in vaccine development, combining recombinant protein production, CMC process and analytical development, adjuvant formulation, preclinical studies, GMP manufacturing preparation and clinical development.

Our core strength is accelerating the transition from research to clinical trials by integrating critical development activities from the outset

We develop and prepare manufacturing processes for GMP production of drug substance (DS), drug product (DP) and investigational medicinal products (IMPs), and facilitate technology transfer to qualified Contract Manufacturing Organizations (CMOs).

Through a multidisciplinary approach, we identify development challenges early, coordinate activities across disciplines and support efficient progression towards clinical readiness.

Our Services

CMC Development and GMP Manufacturing Readiness

Development of GMP-compliant manufacturing processes for recombinant protein drug substances, with particular expertise in Escherichia coli and Lactococcus lactis expression platforms.
Cloning, expression optimization, process development and scale-up preparation.
Development and qualification of analytical methods for drug substance and drug product characterization, release and stability testing.
Formulation development, including vaccine antigens and adjuvants.
Stability study design and execution in accordance with relevant ICH guidelines.
Preparation of manufacturing processes and documentation for technology transfer to qualified GMP CMOs.
CMO selection, qualification and coordination of technology transfer for DS and DP manufacturing

Preclinical Development and GLP Toxicology

Production and characterization of test items for preclinical and GLP toxicology studies.
Preclinical study planning, including study design and CRO selection.
Coordination and oversight of GLP toxicology studies.
Support for the preparation of nonclinical documentation for regulatory submissions

Clinical Development and Regulatory Support

Development of clinical development strategies and plans.
Clinical trial planning, including protocol development, trial design and site selection.
Preparation and coordination of regulatory and ethics committee submissions.
Preparation of Investigational Medicinal Product Dossiers (IMPDs).
Coordination of clinical trial conduct and monitoring in accordance with ICH Good Clinical Practice (GCP).
Preparation of preclinical and clinical study reports

Clinical Trial Supply and Quality Assurance

SSI operates an established Quality Management System (QMS) supporting relevant GLP, GMP, GCP and GDP activities.

Through close collaboration with SSI's Quality Assurance department and Qualified Persons (QPs), we support:

GMP compliance and quality oversight of external manufacturing activities.
Qualification and quality agreements with CMOs and suppliers.
Review of manufacturing documentation and batch records.
Qualified Person certification and batch release arrangements, as applicable.
Packaging, labelling and distribution of IMPs to clinical trial sites.
Preparation and review of quality documentation supporting clinical trial applications

Why Partner with VUA?

Integrated expertise: Multidisciplinary capabilities covering CMC, preclinical development, clinical development and regulatory requirements.

Accelerated development: Early integration of critical activities to reduce development risks, avoid unnecessary delays and facilitate efficient progression to clinical trials.

Extensive experience: More than 25 years of experience developing recombinant protein manufacturing processes and supporting the transition of vaccine candidates into clinical development.

GMP and regulatory expertise: Strong quality and regulatory competencies supporting GMP manufacturing readiness, technology transfer and clinical trial applications.

Let's Advance Your Vaccine Candidate

Looking for an experienced partner to bridge the gap between vaccine research and clinical development?

Contact:
Charlotte Green Jensen
Director, Vaccine Development Department

Email: CGJ@ssi.dk
Phone: +45 3268 3963

Who We Are

NAME	TITLE	EMAIL	AREAS OF INTEREST/RESEARCH
Anne-Marie Winther	Section Manager	amwi@ssi.dk	Active pharmaceutical development
Per Skallerup	Section Manager	prsk@ssi.dk	Clinical and non-Clinical Development
Charlotte Jensen	Head of Department	cgj@ssi.dk	Vaccine Development

Collaborations

VAX2MUC - Next-generation vaccines against moderate inflammation gastrointestinal mucosal pathogens.

Gates Foundation - To support the First in Human trial of a promising, noel tuberculosis vaccine candidate.

FAIR (Flagellin Aerosol therapy as an Immunomodulatory adjunct to the antibiotic treatment of drug-Resistant bacterial pneumonia).

Downloads

Brochure: GXP Services