What we offer
Virtuvax offers guidance in the development of vaccines and biologics from preclinical until
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
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
Assignments in life sciences requiring:
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.