As you know, Biopharm Services has been part of a UK-based consortium consisting of BiologIC Technologies, CPI, Pall Corporation, and SCIEX. The team has announced the launch of a project that aims to develop automated manufacturing controls for use in the manufacture of biologics. The project, worth a total of £3.1million, including equipment contributions, has received support from Innovate UK, to platform this advanced technology (https://www.biopharmservices.com/uk-biomanufacturing-team-to-spearhead-development-of-advanced-controls-to-accelerate-drug-and-vaccine-manufacturing/).
We are fortunate to interview the amazing Harvey Branton who is Head of Technology (Biologics) at CPI.
Welcome and thank you for your time Harvey.
First of all, for our readers’ benefit, would you kindly introduce yourself?
I joined CPI in 2010, my current role is Technology Lead for the Biologics Business Unit. I am responsible for overseeing delivery of a diverse portfolio of projects covering different therapeutic modalities, manufacturing approaches and analytical techniques. I have 28 years of experience in commercial manufacture of biopharmaceuticals and biochemicals. Prior to joining CPI, I spent 13 years at Genzyme in a managerial role, working at the interface between R&D and manufacturing. My knowledge extends through R&D, automation, manufacturing support and production management.
What excites you day to day in your current position?
CPI’s biologics business unit currently has 31 active projects, all of which are pushing boundaries and helping to advance manufacturing capability. Due to the number and diversity of the projects, every day is unique which makes my role very exciting.
This project is building on other work conducted at CPI – what will be the outcome of this project?
With this project we will integrate a continuous protein expression system with the associated downstream purification process to develop a fully integrated, continuous, end-to-end biomanufacturing system. We will be using a novel method of flow balancing which incorporates 3D printed fluidic devices to control and balance process flows. We are also looking at novel process analytical technology (PAT) to monitor and control critical process parameters.
What value does process modelling bring to the project?
The entire process rig will be digitally integrated, allowing us to gather data from all stages and segments of the process. Combined with novel PAT and advanced data analytics, this will provide us with a large amount of data on all aspects of the process. Models built on this data will allow us to optimize the process both from a technical and an economical perspective and enable us to learn for the next generation of continuous manufacturing.
What part does improving manufacturing sustainability play within the project goals?
The overarching goal of the project is to produce a system capable of process intensification. We will use modelling to characterise the system in terms of production and economic parameters. Using these economic models, we hope to be able to measure specific sustainability criteria such as energy utilisation and water usage, and suggest the means to optimise the process performance in these areas.
Will the project be relevant to CPI’s advancement of mRNA vaccine manufacturing?
The architecture of the systems is flexible and could easily support the continuous manufacture of RNA based therapies. The PAT technology and advanced control strategy would need to be adapted to accommodate the specific requirements of RNA manufacture, but the system is designed to enable these types of changes to be easily accommodated.