Plan for success with seamless transfer to phase III production"
Biosimilars are particularly sensitive to changes in the manufacturing process which means you need a partner with a trusted track record. With dedicated project managers with you each step of the way, and our strong emphasis on process development, analytics and comparability testing - you can plan for success.
Our comprehensive facilities - including stainless steel bioreactors – and excellent quality and regulatory experience, means that Menarini Biotech can support you throughout the whole process to ensure seamless transfer from Phase I direct to Phase III.
- Compliance with EMA and FDA cGMP
- Regulatory expertise in biosimilars
- Dedicated facilities for mammalian and microbial production
- Strong expertise in tech transfer and comparability studies
- Extensive analytical capabilities in process control, release and product characterisation
- cGMP scale up to Phase III clinical and commercial production
For success in your Biosimilar manufacturing process, contact us