Bioprocess & Analytical Development (BiPAD)

Contact: Bioprocess & Analytical Development (BiPAD)

The Jenner Institute Laboratories

University of Oxford

Old Road Campus Research Building (ORCRB)

Roosevelt Drive Oxford OX3 7DQ

how can we help you

BiPAD can support your team in taking your ideas from the laboratory to the clinic. Whether you're part of the University of Oxford, from another academic setting, or from industry, our experience across academic and industrial research means we can increase your chances of success.

We can assist you in making sure your product if going to meet the good manufacturing practice (GMP) regulations required for producing medicines and using them in clinical trials. BiPAD is not a GMP manufacturing facility, instead we fill the gap between innovative laboratory research and GMP. We make sure that the processes developed for manufacturing are GMP compliant, that validated analytical assays are in place, and that technology transfer to a GMP manufacturing facility is successful.

It doesn’t matter what stage your project is at: from seeking funds, to developing your bioprocess or preparing to enter clinical trials – BiPAD is here to help in an efficient and cost-effective manner.

Meet the team

The BiPAD team

Sandy Douglas - Director Stanislav Pepeliaev - Team Leader Shawkat Hussain - Senior Scientist

Jackie Chen - Senior Scientist Adam Ritchie - Senior Project Manager

services provided

BiPAD provides support across all the activites in blue, covering all stages of your project from process development, analytics, regulatory affairs, and technology transfer to GMP manufacturers.

Pre-project support

· Advisory on the compatibility of the project with GMP requirements

· Helping with proof of concept and supporting data generation

· Project design

Process development

· Development of GMP-compliant bioprocesses for early-phase trials

· Analytical development and validation

· Optimisation of existing processes to improve scalability or reduce costs

· General bioprocess and analytical support for pre-clinical production of biological medicines

Pre-clinical and Clinical phase I support

· Production of high-quality source materials for GMP campaigns

· Generation of biomaterials for tox studies

· Access to high-efficient platforms and tools

General support

· Consultancy and troubleshooting

· Risk assessment

· Enquiries to MHRA Innovation Office

· Project management

· Equipment access and management

available equipment

Upstream

The BiPAD team has an access to a broad range of process and analytical equipment. The upstream equipment enables the strictly controlled cultivation of a variety of different hosts at different scales (from 1 mL to 10 L and beyond). It consists of

· A range of advanced shaking incubators with CO2 and humidity control;

· Four-fold high-throughput bioreactor system equipped with single-use vessels for faster process development;

· High-volume bioreactor systems with both single-use and autoclavable glass vessels for scale-up verification and material generation;

· Access to clone selection tools.

Upstream equipment

Downstream

The available downstream equipment allows to process the biological material and isolate pure final products at a lab to pilot-plant scale. This includes

· High pressure homogeniser for bacterial and yeast cell disruption;

· Multiple AKTA Pure chromatography systems for protein and nucleic acid isolation and purification;

· Tangential Flow Filtration system for biomolecules separation, buffer exchange and concentration

· A wide range of auxiliary equipment necessary for successful isolation and purification of target molecules

Downstream equipment

Analytics

The quality of target biomolecules is constantly monitored during the process development, material generation and final formulation. A broad range of instruments and techniques is used:

· In-process control sensors

· Cell counter

· Metabolite analyser

· HPLC system equipped with multiple sensors: UV, DLS, conductivity

· Quantitative PCR

· Endotoxin analysis

Analytical equipment

We welcome opportunities for collaboration or business partnership; enquiries can be directed to bipad@ndm.ox.ac.uk