Vaccine Process Development & Technology Transfer

Capricorn Technologies GmbH

Specialist expertise in influenza vaccine process development, from virus production in eggs or cell cultures to purified and concentrated material tailored to vaccine development requirements.

Virus production

We produce influenza viruses in embryonated chicken eggs and in our own or customer-selected cell cultures. We prepare research material and develop processes for influenza and other viruses handled under BSL-2 conditions or below, within our laboratory authorisation. The production system is selected for the virus and intended application.

Purification and final preparation

Our project-specific workflows combine harvest assessment and clarification, ultrafiltration for concentration, and diafiltration for soluble impurity reduction and buffer exchange. Our experience includes hollow-fibre TFF purification of egg-derived influenza without chromatography. Product quality, aggregation and compatibility with subsequent processing guide development.

For egg-derived material, purification can target residual ovalbumin below 1 µg/mL, depending on the starting material and process, with final levels confirmed analytically. Cell culture impurity assessment is matched to the substrate and medium. Final volume, concentration and buffer are agreed for each project; additional filtration, formulation or filling is assessed and defined within scope.

Analytical support

Testing of starting material, intermediates and final preparations can include haemagglutination activity, infectious titre, residual ovalbumin, double-stranded DNA, other agreed impurities and visible aggregates. Tests reflect the production system, development stage and agreed specifications. Reports document methods, results and relevant limitations.

Technology transfer and deliverables

We support transfer to the customer’s manufacturing partner through process descriptions, study documentation, scientific discussions and review of implementation results. Our experience includes external implementation of a Capricorn TFF protocol, with adaptation to receiving-site equipment and identification of further verification needs.

Deliverables may include virus preparations, analytical results, experimental reports, process documentation and transfer support. For GMP programmes, we provide development and transfer support; GMP manufacture, validation and batch release are performed by an appropriately authorised manufacturing partner.

Discuss your project

Contact us to discuss your virus, production system and development requirements.