MilliporeSigma, one of the world’s leading science and technology companies, offers contract development and manufacturing (CDMO) services through BioReliance® End-to-End Solutions. The company has a global network of three biodevelopment centers in France, China and the U.S. leveraging their own single-use technology. Designed to meet the unique needs of startups and mid-sized biotechs, services and expertise support the entire workflow, from cell line and process development to GMP manufacturing.
What are the major strengths and attributes of your company
We have a long history of contract development and manufacturing success with 33+ years of experience in process development and 25+ in GMP production. When outsourcing, biotechs can find it necessary to work with several partners throughout the project. So, the more in-house expertise a CDMO can offer, the easier the organization and communication of the project. Our experts have experience with 250+ biologics including monoclonal antibodies, bispecific antibodies, ADCs, and fusion proteins, including numerous IND/IMPD filings and extensive experience with regulatory agencies. Our wealth of in-house expertise and proven solutions position our clients for success from the earliest stages, including some of the molecules being commercialized today.
Which particular contract services are most in demand?
Many biotechs turn to a trusted CRO or CDMO to guide them through the different stages of drug development and to bring the necessary expertise and infrastructure. We see rising demand for flexibility, speed, and quality. The flexibility of the partner determines the speed. A partner who can deliver a batch with the right quality attributes, at the right time, in a cost-effective manner, and who is as adaptable as possible, can bring a competitive edge. With our depth and breadth of expertise in analytical, and process development, GMP manufacturing and regulatory affairs, our team effectively balances speed and risk and applies innovative approaches to optimize processes, without sacrificing quality.
Who are your biggest customers?
We establish strong working relationships with our clients and give them the attention they need, independent from their size. We are working with startups as well as mid-sized biotechs like Acticor Biotech and Turgut Ilaç. Many projects that started small led to major drug developments and successful market introductions. We take the time to understand our clients’ goals and make them ours. We ask questions about how fast a client needs to go and the acceptable level of risk. From those insights, we establish the strategy and design solutions, tailored to each molecule and project.
Being adaptable by nature, we offer a flexible model for engagement that can include fast-track development, helping to ensure streamlined progress toward every milestone from DNA to market.
What are your most successful projects or partnerships over the past few years?
Every drug development process is different, and the question is, how does the CDMO partner adapt? A few years ago, we took on a project in which the cell line had already been developed by another company. The previous company had run it three times and received three different results. So, there seemed to be a problem with the process
robustness. We proposed to the client to take the cells and screen some upstream conditions to have a new cell culture process in place. We did that in a matter of four weeks. We knew that the productivity was so low that the cost per gram was in a range that the customer could not have handled during the commercial phase. The project would have been a failure. But by re-screening the cell culture conditions, our experts managed to change the plan, adapt the size of the team in order to run several screening conditions in parallel, and gain positive results for our client. That client will be commercial this year.