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 is 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 activities 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 

• Two electroporators - Nucleofector from Lonza for classic electroporation of cell cultures; and Expert VLX from Maxcyte for high-volume flow-through electroporation particularly useful for transient expression.  
• 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 AKTA Pure 25 chromatography systems (with sample pump) for protein and nucleic acid purification, including system(s) in cold room to enable protein purification at low temperatures. AKTA pure chromatography system allows for quick and easy customisation thanks to the modular design of both the hardware and software.
• cGMP compliant AKTA Ready 450: fully single-use chromatography system for those who require processing large volumes for scale-up and pre-GMP engineering runs
• Tangential Flow Filtration (TFF) systems: Repligen KrosFlo® KR2i and KMPi for biomolecules separation, buffer exchange and concentration.  It is a fully integrated and easy to use system with walkaway automation capable of processing 2mL - 100L volumes using the filters with 13 cm² - 2.5 m² 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), fluorescence detector (FLD).
• Digital PCR for absolute quantification: Qiacuity Four (capable of processing 4x96 well plates in approximate 8 hours) from QIAGEN features precise and multiplexed quantification results for mutation detection, copy number variation (CNV), gene expression studies, gene-editing analysis, and many more. Possibility of utilising QIAgility to automate sample preparation and processing.
• Endotoxin analysis – Endosafe nextgen-PTS instrument
• Mass Photometry (Refeyn TwoMP and Karitro MP): The TwoMP has a wide mass range, allowing the study of different biomolecules, including proteins, DNA, RNA, large macromolecular complexes, nanostructures and even small viruses such as AAVs. The KaritroMP makes it easy to quickly characterise samples of large viral vectors (adenovirus, lentivirus) and virus-like particles (VLPs).

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