Process development and manufacturing capabilities:
- Cell line development and optimization
- Cell banking and storage
- Safety testing and characterization
- Process development and up-scaling
- Tox manufacturing
- cGMP manufacturing
- Stability testing and assay validation
- Regulatory support for IND and BLA
- Process validation
- Conjugation
- Formulation, lyophilisation and vialling
- QA release of DS and DP
Manufacturing
Process development and antibody manufacturing are core competences of BioInvent. We have a cGMP-certified manufacturing facility, which meets FDA and EU standards for production of antibodies for uses ranging from research, early clinical development through to commercialisation. We use this facility to produce materials for our own clinical trials. As such we can maintain full control of this important part of the drug development process, which is beneficial from a quality, a timeline and also a cost perspective.
As well as using this facility to produce our own products, external partners can also access BioInvent's expertise in antibody drug development. We offer tailor-made solutions to meet the specific needs of each client. Projects can include stable cell line development, process development and/or antibody manufacture. Each client has a dedicated manager assigned to them, to ensure the smooth running of the project.
BioInvent has several years' experience of providing pharmaceutical and biotechnology companies with purified therapeutic-grade antibodies. We have manufactured a variety of antibodies in mammalian cell lines for use in Phase I to III clinical trials, in vitro diagnostics and numerous development projects.
BioInvent has a multi-product facility consisting of three culture suites with purification capacity.
Our in-house cell line development team works closely with the process development and cGMP manufacturing teams. We have extensive experience in developing stable antibody-secreting CHO and NS0 cell lines. Using the Lonza GS gene expression system, we can generate stable cell lines within six months, with expression levels meeting the best industry standard.

