Biologics manufacturing is a technologically complex and highly regulated process. Recent directives also consider minimising risks from early stage clinical trial product. The new directives, requiring product to be produced according to GMP, is increasing the burden on early stage companies and research groups to assure GMP manufacturing capacity and experience in producing product.
Rodon has extensive experience in the creation of the chemistry, manufacturing, and control (CMC) project plans to meet the strict FDA requirements for INDs, NDAs, and commercialization. Thanks to our years of experience in development, scale-up, validation and transfer of bioprocesses Rodon is centred in the manufacturability of the products from the early phases of development: whenever possible single use technology are used for faster, more efficient tech transfers; non animal derived process materials with history in Biologics manufacture are used; process materials are selected based on a combination of maximal yield and minimal cost-of-goods; use of scalable unit Operations.
The developed processes are transferred into client’s manufacturing facilities and/or third party Contract Manufacturing Organisations (CMOs). With Rodon experience it is possible to give the client a better understanding of the road map ahead up to product manufacturing, facilitating CMO selection. Rodon can manages the manufacture of client’s products, for all stages of clinical trials and commercial use, with the services of CMOs and Contract Analytical Laboratories (CAL) with proven capabilities in GMP/GLP standards of operation. On alternative it can support the CMO and/or CAL selection according to the client suggestion. Prior to transfer the process and analytics are well characterised and demonstrated to be appropriate, consistent and robust. All process related information is detailed documented to facilitate transfer and support regulatory filing.
Rodon dedicated and knowledgeable team assures continuing and effective planning, co-ordination and communication between all parties, at all levels, throughout the project, from the developing into manufacturing. Rodon works with a close relationship will all parties, at both the commercial and technical level, to ensure the efficiency and success of the project.
We Offer More
Looking for additional services? We offer even more services than listed, contact us to find out how we can assist you. Using latest advances in Protein Technologies Rodon Biologics strives to provide the highest quality custom protein services in the industry. We work closely with you, analyze your project at the planning stage and take several approaches to ensure you get the results you are looking for.Know More