Biologics Process
Development
Our key SME’s have an average of 15+ years’ experience in microbial process development for protein and nucleic acid biologics. We develop your manufacturing processes for scale-up for clinical and commercial production, efficiently and at the required product quality so you more rapidly reach the market.
Upstream Process Development
We can develop processes for clients with no existing upstream process, or we can optimise existing processes. We possess a wide range of public-domain, royalty free expression vectors for E. coli. We also offer expression studies and cell bank generation in E. coli cell lines for soluble expression.
A Seamless Scale-Up from Development to Manufacturing
Our approach to process development emphasises Quality by Design from the outset. We work with our clients to fully understand the product concept and record this in a Quality Target Product Profile (QTPP). From the profile, we develop a process and an associated control strategy to ensure our clients’ products and processes can be relied upon to be robust, stable and suitably designed for future scale-up. Our manufacturing processes utilise fully enclosed, single-use systems for both buffers and process intermediates which helps ensure sanitary production conditions throughout manufacturing.
We have extensive experience in development of fermentation, product recovery, refolding, chromatography, filtration, tangential flow and hollow-fiber filtration operations and the development and manufacturing equipment to seamlessly scale-up these operations from laboratory bench to full commercial production scale.
Our knowledge and experience through the development lifecycle of pre-clinical to commercial manufacturing ensures we understand the broad range of studies required and the appropriate time and project phase to complete these studies.
Upstream Process Development Equipment and Technology
- Parallel fermentation in up to 8 bioreactors at 400 mL – 1 L scale for rapid process characterisation and optimisation using the DASGIP parallel Bioreactor System.
- The Biostat® Cplus is a Sterilize-In-Place (SIP) 20L stainless steel fermenter and bioreactor for the cultivation of microorganisms and cell cultures. With more than a thousand installations worldwide, the Biostat® Cplus is the most successful bioreactor of its class.
- Homogeniser for disruption of cells, if required
- Batch and Continuous Flow centrifugation for recovery of cells and inclusion bodies in a manner that can be scaled-up in our production facilities.
Downstream Process Development Equipment and Technology
- Refolding for inclusion bodies utilising our platform and JMP software from SAS for Design of Experiments and data analysis
- AKTA™ Avant, AKTA™ Pilot, and AKTA™ Explorer for development of scalable chromatographic purification processes
- AKTA™ CrossFlow for tangential filtration process development using QbD methodology
Plasmid Process Development Equipment and Technology
- Continuous flow cell lysis reactors that can be scaled-up to 300 L of fermentation, to ensure efficient lysis of fermentate
- Development and manufacturing equipment to seamlessly scale-up from laboratory bench to full commercial production scale, with a dedicated laboratory for pDNA purification
- AKTA™ Purifier, AKTA™ Flux 6 and AKTA™ Flux S for plasmid purification and concentration
- A purification platform based on the Sartorius Convective Interaction Media (CIM®) monolith chromatography for purity, scalability and speed of purification
- Qualified analytical methods for confirmation of supercoiled plasmid, residual host cell DNA, host cell protein and residual RNA
mRNA Process Development Equipment and Technology
- Dedicated laboratory for plasmid linearisation, mRNA transcription and purification, utilising the AKTA™ Purifier, AKTA™ Flux 6 and AKTA™ Flux
- Development and manufacturing equipment to seamlessly scale-up from laboratory bench to full commercial production scale, with a dedicated laboratory for mRNA purification
- Encapsulation equipment* to develop mRNA products. At BioCina, we use the NanoAssemblr® Spark™, Ignite™ and Blaze™ systems from Precision Nanosystems, to efficiently scale LNP products, from the small volumes required for in-vitro studies, up to those required for late-stage pre-clinical.
*Manufacturing equipment train will be installed and qualified by Q4 2024
Process Development for Every Offering
Microbial
A full service offering that can take you from gene sequence to Master Cell Bank and develop upstream and downstream processes, ready for scaling-up to our production fermenters and purification systems in the GMP suites.
Plasmid DNA
Plasmid purification and qualified analytical methods required to demonstrate your process is ready for clinical production.
mRNA
Our expert mRNA team brings deep experience to very step of your program, from development through production.
LNP
Lipid Nanoparticle (LNP) encapsulation services offering can support a wide range of applications.
Drug Product
Development, formulation, and analytical services for sterile liquids, clinical and commercial fill and finish manufacturing for small molecules and biologics.