Our Microbial Offering
Our team offers tremendous experience in microbial-based process development and clinical and commercial manufacturing, with most critical SME’s having an average tenure of 15+ years at the Adelaide site.
Our approach to process development emphasizes Quality by Design from the outset. We work closely with our clients to fully understand the concept product and establish a Quality Target Product Profile (QTPP). From the profile, we develop a process and a control strategy, to ensure our client’s product and process 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 conditions throughout manufacturing.
Our state-of-the-art facility offers development and manufacturing equipment to seamlessly scale-up from laboratory bench to commercial production scale.
BioCina’s knowledge and experience of partnering with our clients from pre-clinical development to commercial production ensures we are capable of navigating your journey to approval.
Microbial Manufacturing Equipment and Technology
BioCina’s state-of-the-art facility offers highest quality microbial cGMP cell banking and manufacturing. Our microbial equipment and technology includes:
- Single-use fermentation up to 300 L and up to 500 L stainless steel fermentation
- Midstream processing capability, including continuous flow centrifugation and high-pressure homogenization
- Cell lysis technology
- Refolding capacity up to 3,000 L
- Downstream purification technology includes AKTA™ Isocratic and AKTA™ Gradient Chromatography skids and columns
- UNIFLUX™ and Repligen Tangential Flow Filtration Systems
Services for Your Program Phase
Quality &
Regulatory
We successfully develop and manufacture your microbial product, from clinical stage through commercialisation, ensuring a robust and scalable process that maintains the highest product quality.
Process
Development
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.
Analytical
Development
Development of new analytical methods and tech transfer of established methods, validation and extended product characterisation, and stability testing.
cGMP
Manufacturing
Featuring a hybrid manufacturing model with both stainless steel and single-use fermenter systems for DS production, in a single highly integrated facility.
Technology
Transfer
Our systematic technology transfer approach, includes thorough gap analysis and robust risk mitigation.
Our Expertise On Demand
Thought Leadership & Resources
