Virtuvax offers guidance in the development of vaccines and biologics from preclinical until

marketing through:

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Technical consultancy 

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Strategy design
Design of a development strategy with the end-point in mind such as the design of a target product profile (TPP) plus Quality-TPP (QTPP) following the principles of Quality by Design (QbD) or installment of a complete integrated development plan (IDP) including milestones, objectives, risk assessment/alternative development options to ensure delivery on time and on budget.

Pre-clinical, Chemistry, Manufacturing and Controls (CMC) and Clinical Drug Development

• Non-clinical development program: pre-clinical efficacy and safety study design and execution, preclinical assay design

• Biomarker development: assay design, standardization and analytical validation in accordance with ICH guidelines; test development in accordance with medical device regulations

• Design of a product development plan

• Clinical studies: (assistance in) design and scientific writing of IMPD/IND; Pharmacovigilance: design and evaluation of phase IV clinical, CRO management

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Life cycle management

Technology transfer: product/technology evaluation, feasibility study design, gap assessment and risk management, design of in-licencing / out-licensing contracts and transfer package

 

Interim assignments

 

Assignments in life sciences requiring:

• Line management

• Vendor management

• Project management

• Business development

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Programs for development of biosimilar vaccines

 

Global demand for vaccines is increasing, especially in emerging markets. The increasing demand for vaccines, warrants the expansion of local production in emerging economies and increases the need for biosimilar technologies. For the establishment of such production technologies, access to the appropriate vaccine seeds and/or production cell lines as well as the transfer of know-how to develop, produce and register vaccines. In some cases a production plant needs to be adapted or newly built. We offer a tailor-made approach that includes the identification of the required production technology and a strategy to acquire such. We develop and transfer essential process steps and we help in the development of a regulatory strategy, such as a roadmap for local marketing authorization or WHO prequalification. Moreover, we design and install a production facility together with our partners.