The new Rentschler Biopharma Manufacturing Center US (RBMC US) will add 22,000 square feet of manufacturing cleanroom space. The site is expected to become operational in late 2023, with the building design aimed at accommodating future adaptations for scale and capacity, said the CDMO.
Commenting, Dr Frank Mathias, CEO of Rentschler Biopharma SE, said: “With Rentschler Biopharma’s contribution to the production of mRNA vaccines to beat the COVID-19 virus, we have seen firsthand how important it is to have highly adaptable capacity and to have the experience and expertise needed to produce new therapeutic modalities, fast. The US expansion we have kicked off at the groundbreaking is part of our ongoing plan to strategically grow our business as we support our clients in developing and manufacturing even highly complex molecules.”
Dr Cora Kaiser, senior director, corporate communication, Rentschler, told BioPharma-Reporter the new production site will leverage 4.0 solutions:
“We will use digitization guided by Industry 4.0 to improve efficiency, effectiveness, and insights across all processes, including supply chain, process science, manufacturing, and quality.”
Continuing, she said, that as the design is formalized, the manufacturing equipment, data acquisition, instrumentation, laboratory, and overarching control systems will be integrated to:
- Leverage data from our manufacturing, lab, and supply chain systems to apply advanced analytics for impactful and actionable insight.
- Install integrated equipment control systems for simplicity of operations and process automation. Rentschler Biopharma will integrate key functions such as in-line quality control sampling during manufacturing.
- Provide clients timely data and information access for informed decision making.
- Design network and data architecture to enable integration and automation opportunities for efficient client release.
Bioreactor investment to enable production flexibility
The facility will also enable production flexibility as the site was designed to address customers changing and increasing needs, she reported.
“Flexibility was a top requirement for the design. Key features to ensure that include four 2,000L bioreactors, which enable easy scale up from clinical to commercial scale for multiple products.
“Upstream ballroom processing and downstream processing suites equipped with buffer storage and preparation space will allow the plant to handle both small-scale and large-scale projects, based on individual clients needs at a given time.
“We also expanded QC, development, and warehousing capabilities so that we will be able to efficiently manage multiple projects of varying size at one time.”
How wide a reach will this site have in terms of customers?
“The focus of the new site will be on commercial-stage complex biopharmaceuticals for US-based clients. Rentschler Biopharma's clients range from small biotech to big biotech to big pharma.
“We currently have a 500L bioreactor at our existing site in Milford; the new site will have four 2,000L bioreactors; so, this will significantly increase our current capacity to serve our US clients and add capacity for commercial manufacturing. In fact, the new site will double our overall global commercial cGMP manufacturing capacity, as well as provide additional development and analytical services to our clients, strongly enhancing our value proposition in commercial manufacturing."