BIO
The next great step in RNA manufacturing: Continuous and integrated processing
ReciBioPharm has teamed up with the Massachusetts Institute of Technology (MIT) on a mission to accelerate RNA drug product production and increase product purity and yield.
Leveraging continuous and integrated processing, inline Process Analytics Technology (PAT) and centralised control, our continuous RNA manufacturing platform harnesses innovation to elevate operational effectiveness and deliver breakthroughs.
This development program is supported by the FDA’s Center for Biologics Evaluation and Research (CBER) Advanced Technology Program.
Propelling your RNA therapy towards patients
Our AI-enabled continuous manufacturing service aims to deliver novel nucleic acid therapeutics to patients at an unprecedented pace.
Leveraging our established leadership in mRNA manufacturing, our platform — Continuous Process 1.0 (CP1) — is set to advance rapidly through focused process development, process analytics and AI to deliver your therapy to patients quickly through three key pillars:
- Rapid process development
By developing a digital twin for process optimisation and leveraging next-generation technologies to establish predictive models, our platform reduces process development (PD) times by up to 90%. - Continuous and integrated process
Inline process analytics and real-time quality control (QC) release prevent interruptions and promote the daily output of drug product, increasing manufacturing speed by up to 85%. - Centralised process control
Embracing hands-off automation, our platform moves away from unit operation control to single-point operation that is adaptable to future-generation instrumentation.
Our AI-enabled continuous manufacturing service aims to deliver novel nucleic acid therapeutics to patients at an unprecedented pace. Leveraging our established leadership in mRNA manufacturing, our platform — Continuous Process 1.0 (CP1) — is set to advance rapidly through focused process development, process analytics and AI to deliver your therapy to patients quickly through three key pillars:
Rapid process development
By developing a digital twin for process optimisation and leveraging next-generation technologies to establish predictive models, our platform reduces process development (PD) times by up to 90%.
Continuous and integrated process
Inline process analytics and real-time quality control (QC) release prevent interruptions and promote the daily output of drug product, increasing manufacturing speed by up to 85%.
Centralised process control
Embracing hands-off automation, our platform moves away from unit operation control to single-point operation that is adaptable to future-generation instrumentation.
Adopting an agile development approach, CP1 supports non-GMP drug product generation with the same critical quality attributes (CQAs) as existing GMP processes.
Ready and commissioned to produce 0.5 to 1.0 g/day of mRNA drug product, CP1 harnesses innovation to optimise your RNA production process with a manufacturing time of less than 2 weeks.
AI-enabled cGMP manufacturing under development with CP2
To meet your needs as your RNA project progresses, we are developing Continuous Process 2.0 (CP2) to support cGMP large-scale processes with integrated next-generation technologies.
CP2’s digital twin model will harness artificial intelligence (AI), the latest process analytical technologies, automated visual inspection and in-line analytics to optimise:
- In vitro transcription (IVT)
- Tangential flow filtration (TFF)
- Chromatography
- Lipid nanoparticle formulation.
Leveraging real-time data to predict changes, we will adapt process parameters as needed to ensure the successful manufacturing of your RNA therapy as it scales.
Our partners
As part of the FDA’s initiative to create a fully integrated, continuous manufacturing production line for RNA vaccines, our collaborators at top institutions are working to develop cutting-edge, focused technologies in TFF, chromatography, precipitation and lyophilization.
Harnessing these innovations, our platform will continually evolve to deliver therapeutic breakthroughs to patients now and in the future.
Want to know more about our full biologics service offering?