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

Emails: bipad@ndm.ox.ac.uk

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

 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.

 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 

• High-capacity three-tier stackable Sciquip shaking incubator with temperature, CO₂ and humidity control.  Thanks to the variable orbital shaking diameter from 1 to 50 mm it is suitable for the cultivation in plates and flasks up to 5 litres.
• Four-fold high-throughput Eppendorf DasGip bioreactor system equipped with single-use 1-L vessels for faster process development or parallel production of small quantities of biologics. The DasGip system is very flexible and can be adapted to almost any bioprocess. Currently the system is configured for mammalian cell cultures.
• High-volume bioreactor system Sartorius Biostat equipped with a 10-L glass vessel is configured for high-cell-density microbial applications (bacterial and yeasts)
• Highly configurable bioreactor system Eppendorf BioFlo 320 is configured to work with single-use vessels ranging from 1 to 50 litres and is dedicated to mammalian cell culture cultivations. Both high-volume bioreactor systems are used either for scale-up verification prior the tech transfer to a GMP production facility, or for material generation.
• Access to external clone selection tools.

 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.
• Several ÄKTA Pure 25 chromatography systems for protein and nucleic acid purification. ÄKTA pure chromatography system allows for quick and easy customization thanks to the modular design of both the hardware and software.
• Tangential Flow Filtration (TFF) system Repligen KrosFlo® KR2i for biomolecules separation, buffer exchange and concentration.  It is a fully integrated and easy to use system with walkaway automation capable of processing 2ml - 15L volumes using the filters with 13 cm² - 5000 cm² filtration area.
• A wide range of auxiliary equipment necessary for successful isolation and purification of target molecules

 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 such as pH, pO₂, temperature probes allow controlling and maintaining the optimal cultivation conditions in the bioreactors; pressure sensors control filtration processes during TFF.
• Cell counter NucleoCounter® NC-202 is a cassette-based cell counter able to measure up to 1x10⁷ cells/ml in just 30 seconds
• Metabolite analyser Nova Prime® CCS Analyzer measures the most critical parameters: pH, p_CO2, p_O2; concentrations of the most important ions: Na⁺,   K⁺,   Cl^–; concentrations of key metabolites: glucose and lactate.
• The advanced fully featured HPLC system Agilent 1260 Infinity II allows running multiple tests using an extensive range of detectors: UV, dynamic light scattering (DLS), high temperature dual angle light scattering (HT-DALS), refractive index detector (RID), fluorescent detector (FLD).
• Quantitative PCR
• Endotoxin analysis – either kit-based or accessing an external Endosafe nextgen-PTS instrument

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