Biopharma manufacturing involves the complex interaction of several unit operations working collectively at various scales. Regulation of these unit operations enables the production of high-quality products at various stages of production, but requires careful coordination between:
cGMP & CMC Initiatives
From benchside to commercial scale, Basetwo enables manufacturers to optimize and understand the mechanisms driving batch, fed-batch, and even continuous bioreactor systems.
Using the Basetwo platform, process engineers can build high-fidelity predictive models to maximize reaction efficiency and understand the influence of process disturbances.
Chromatography is a high complex unit operation. Using the Basetwo platform, engineers can confidently build and validate digital twins capable of optimizing loading flow rates in various chromatography systems and improve their causal understanding of conditions influencing product yield and quality. Integrated process modeling allows for optimization even in sequential chromatography steps or in continuous systems to optimize purification.
Technology Transfer & Scale-up
Scaling a process from the benchtop to commercial scale is a significant challenge as process dynamics at the benchside do not always translate to commercial scale or at a different site.
With Basetwo, manufacturers can use process development and commercial data to build a process model that learns how process dynamics change with scale, enabling a more predictable scale-up and tech transfer process to improve time to value and minimize risk.
Resin Lifespan Extension
Resins are a highly costly resource that require regular cleanings and degrade exponentially with use, often leading to suboptimal retiring of columns that can affect product yield and quality.
Using Basetwo, engineering teams can reliably forecast resin performance to enable better cleaning protocols and maximize the lifetime of the resin without compromising performance.