InSight Biopharmaceuticals Ltd., has vast experience for over 20 years in the development and commercialization of manufacturing technologies for biopharmaceuticals.
With our modern R&D laboratories, one of the most equipped in Israel and our highly experienced R&D and operational team, InSight has a demonstrated success with all aspects of process development, from DNA to commercial scale manufacturing of active substances for biopharmaceuticals.
InSight offers a one stop shop for the development, characterization and manufacturing of protein therapeutics with a tailor-made, customer attentive approach. Our team provides the necessary expertise, quality, infrastructure and project management to ensure efficient, timely and successful deliverables to our customers.
We now offer efficient and cost-effective, tailor made, contract development and manufacturing services.
InSight’s R&D team has experience with a variety of mammalian and bacterial cell lines.
- Experience with a variety of mammalian and bacterial cell lines
- Vector design, optimization and construction
- Clone establishment and selection (including ClonePix® services)
- Bioprocess development (upstream and downstream) at lab to pilot scale (100L)
- Analytical methods development (including HPLC and UPLC with various detectors – UV PDA, Fluorescence, RI; CGE, CIEF, CZE, Static and Dynamic Light Scattering and others)
- Bioassay development (including cell-based assays, ligand and Fc receptor binding kinetics by Octet, ELISA, MSD and others)
- Glyco-analysis (HILIC and CE-LIF)
- Method qualification and validation
- Commercial scale (up to kilograms batches), under full GMP umbrella, of mammalian cells-derived recombinant active substances (e.g. cytokines, hormones, mAbs) in fed-batch and perfusion systems
- Writing all GMP documents: batch records, validation protocols & reports, SOPs
- Responsible pharmacist & EUQP release services for clinical and commercial batches
- GMP Quality Control laboratory services: method validation, release tests stability studies under all climatic zones conditions
- Regulatory Affairs support