Microbial CDMO Services for Biologics Manufacturing
Our team offers tremendous experience in microbial-based process development and clinical and commercial manufacturing. As a leading microbial CDMO, our SMEs hold an average tenure of 15+ years at the Adelaide site.
Our approach to process development emphasizes Quality by Design from the outset. As part of our microbial CDMO services, 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, helping ensure sanitary conditions throughout manufacturing.
Our state-of-the-art facility supports our microbial CDMO services by offering development and manufacturing equipment to seamlessly scale-up from laboratory bench to commercial production scale.
BioCina’s knowledge and experience as a microbial CDMO, partnering with 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 delivers industry-leading microbial CDMO capabilities, supporting high-quality GMP manufacturing, including cell banking and large-scale production. Our infrastructure is designed to enable efficient upstream and downstream processing, purification, and scalable manufacturing using both single-use and stainless steel system.
Our microbial equipment and technology includes:
- Single-use fermentation up to 300 L and up to 500 L stainless steel fermentation, supporting flexible GMP manufacturing
- Advanced upstream and midstream processing capability, including continuous flow centrifugation and high-pressure homogenization
- Cell lysis technology for efficient product recovery
- Refolding capacity up to 3,000 L for complex protein production
- Downstream purification systems, including AKTA™ Isocratic and AKTA™ Gradient Chromatography skids and columns
- UNIFLUX™ and Repligen Tangential Flow Filtration Systems for high-efficiency purification and concentration
End-to-End Microbial CDMO Services
Our microbial CDMO services support every stage of development, from clinical stages to full commercial manufacturing.
Quality &
Regulatory
From clinical development to commercial scale, we manufacture your microbial products with a focus on quality and scalability. Our microbial CDMO services offer full GMP compliance and global regulatory support, streamlining approvals to ensure your product is market-ready worldwide.
Process
Development
A full-service offering that can take you from gene sequence to Master Cell Bank, including microbial strain development and upstream & downstream optimization. Our approach ensures processes are fully developed and ready for seamless scale-up to our production fermenters and purification systems within GMP-compliant suites.
Analytical
Development
Development of new analytical methods, including method validation and tech transfer of established methods. Our capabilities also include comprehensive product characterization and stability testing to ensure product quality, consistency, and regulatory readiness.
cGMP
Manufacturing
Featuring a hybrid manufacturing model with both stainless steel and single-use fermenter systems for drug substance (DS) production, enabling seamless clinical to commercial scale and supporting efficient biologics manufacturing within a single highly integrated facility.
Technology
Transfer
Our systematic technology transfer approach includes thorough gap analysis and robust risk mitigation, enabling seamless scale-up and effective knowledge transfer across development and manufacturing stages.
Microbial CDMO Expertise & Insights
Explore insights, case studies, and industry updates related to microbial CDMO services and biologics manufacturing.
