Expert GMP manufacturing from concept to clinical batches

Developing a robust, scalable manufacturing process, and producing safe and effective vaccines that meet global regulatory requirements is a technical challenge. Our process development and GMP manufacturing services help you every step of the way, from concept and strain construction to preclinical assessment. We provide comprehensive support and expertise to turn your promising research into clinical batches, whether viral, bacterial, or oncological vaccines. With a variety of production technologies in single-use and stainless-steel bioreactors with up to 200 L capacity, 230 sqm of GMP cleanrooms (class C) and quality control, and a reliable network of service partners, we can produce vaccines for testing in phase I/II clinical studies.

Intravacc's research, development, and GMP facilities

Key GMP capabilities and support:

BSL-2 clean room (class C)
Drug substance manufacturing
1 to 200 L single-use bioreactors and bag systems
DSP equipment matching defined production scales
Technology transfer
CMC writing for IND/IMPD through our preferred partner

Get more details about our GMP manufacturing services.

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Quality control (QC) testing and stability studies

Our QC expertise includes assay validation, sampling and testing of raw materials, and management and execution of stability and release testing for your vaccine in compliance with GMP.

Key QC capabilities and support

GMP-compliant QC laboratories
Qualified QC technicians
GMP-compliant sample management
In-house developed and validated analytical techniques, including virus titration, protein content, immunoassays (ELISA), qPCR, HPLC, mass spectrometry, NMR, and SEC- and FFF-MALS
Compendial assays that include pH, osmolality, and appearance

Accessible QC capabilities

General (microbiological) analytical techniques are outsourced to our preferred partners. These techniques include assessments of sterility, bioburden, endotoxin, mycobacteria, and mycoplasma, particulate matter subvisible, TOC and nitrates, as well as DNA fingerprinting and deep sequencing.

Assay validation services

QC includes support in the development and validation of product specific analytical techniques at the highest standards of quality. Validation of assays is performed according current ICH Q2 guidelines.

Tailor-made GMP production capabilities

With state-of-the-art manufacturing facilities and a wide range of analytical techniques, we offer focused and customized support for your vaccine development project. Furthermore, our clinical, quality affairs, and regulatory teams have the expertise needed to comply with the latest GMP standards.