Commercial Process Development for Continuous Biomanufacturing

The Journey from Clinical Development to Commercial Manufacturing

Commercial Process Development (CPD) is a set of activities for optimizing bioprocesses following early-stage clinical development and in preparation for commercial manufacturing. CPD can be performed on either existing continuous or fed-batch antibody manufacturing processes. Existing fed-batch processes are converted to our continuous manufacturing platform during CPD. This allows biopharmaceutical companies that have manufactured in fed-batch previously to launch their products with lower manufacturing costs, greater agility, and less risk.

Benefits of Developing a Continuous Process for Commercial Supply

Increased Biomanufacturing Agility

  • Individualized batch outputs from 5 to 2,000 kg to meet fluctuations in market demand
  • <2 years for a new facility with our J.POD design
  • Flexible manufacturing expansion using off-site constructed POD modules

Lower Bioproduction Risk

  • Tunable product quality allows process optimization without regulatory risk
  • Avoid geopolitical instability with cloned J.POD facilities in US & EU
  • Option to integrate process into clients’ facilities

Lower Antibody Manufacturing Costs

  • 75% reduction in COGM targeting <$50/g
  • Two thirds reduction in CAPEX compared to other commercial-ready facilities
  • Small footprint facilities have lower operating costs

A Roadmap to Commercial Launch with a Continuous Manufacturing Platform

Partners with projects that have previously utilized a fed-batch process typically request a feasibility study before transitioning to CPD. These studies assess the viability and practicality of implementing CM for a specific application.

Emily to add teaser to Feasibility Studies page once it is set live.

Existing projects with continuous manufacturing processes proceed directly into CPD.

Roadmap To Commercial Launch CMP

Commercial Process Development

CPD at Just – Evotec Biologics fulfils three main functions:

  1. Establishing an End-to-End Continuous Manufacturing Process: Just – Evotec Biologics establishes a 25-day continuous manufacturing process for their partner’s molecule. This end-to-end approach ensures seamless production, from raw materials to the final product.
  2. Robustness Demonstration: The CPD team rigorously tests and validates the process to ensure its robustness. This involves assessing factors like scalability, stability, and reproducibility. Robustness is critical for consistent product quality and reliable commercial supply.
  3. Commercial-Ready Analytical Strategy: Developing a robust analytical strategy is essential for commercial success. It involves methods for assessing product quality, purity, and safety. Just – Evotec Biologics uses analytical techniques that meet regulatory requirements and support commercial-scale production.

Late Phase Clinical Development and Regulatory Submissions

Just - Evotec Biologics provides partners with a clear pathway from Commercial Process Development through to BLA Submission via the following steps:

  • Scale-up and Engineering Runs
  • Clinical Manufacturing
  • Comparability Testing
  • Process Characterization and Validation
  • Biologics License Application Preparation and Submission