Microbial Drug Substance From Bench to Scale
Microbial Expression Systems
Our primary and most experienced expression host, responsible for approximately 30% of all FDA and EMA approved recombinant biologics globally. Extensive K12 and B strain library with licensed and non-licensed options.
Choose The Right Expression System For Your Program
Strain Selection and Characterization
We screen regulatory suitability candidate strains for productivity and genetic stability. Rigorous early strain characterization sets the biological foundation for a reproducible, scalable cGMP manufacturing process.
Fermentation Process Control
Our cGMP fermenters are equipped with precise controls on dissolved oxygen, pH, temperature, and feed control. Process parameters are systematically optimized through design of experiments to maximize yield and batch-to-batch consistency.
Downstream Purification Validation
Multi-step purification trains incorporating ion exchange, hydrophobic interaction, and size exclusion chromatography validated for high product yield, host cell protein and DNA removal, and endotoxin clearance.
Inclusion Body Refolding
Dedicated refolding infrastructure, with DOE-driven optimization to establish reproducible refolding conditions from clinical through to commercial scale.
cGMP Manufacturing Readiness
Process characterization studies, scale-down model development, and technology transfer documentation prepared in parallel with cGMP campaign readiness, compressing development timelines without compromising regulatory confidence.
Microbial Development and Manufacturing
Upstream process development and fermentation optimization refined for your strain and expression system.
What We Manufacture
Molecule Classes
Therapeutic Areas
End-to-End Support for Your Microbial Program
Explore the development and manufacturing services that underpin every microbial drug substance program at BioCina.
Cell Line Development
01
Where Your Biology Meets Our Expertise.
We develop robust, well characterized cell lines that support reliable expression and long-term manufacturing consistency throughout your program.
Process Development
02
Processes Designed to Grow With Your Program.
From bench to commercial scale, we develop bioprocesses built for reproducibility, regulatory confidence, and the long-term success of your therapy.
Analytical Development
03
Analytical Methods Built Around Your Program.
We develop, optimize and validate the analytical methods your program needs, from early characterization through to regulatory submission, with rigor at every step.
Tox Batches
04
Building Confidence Before You Scale.
We execute early-stage manufacturing runs generating the safety and process data your program needs to advance with clarity and confidence.
Process Validation
05
Validation Built for Regulatory Confidence.
We execute rigorous process validation to the standards of the world's most demanding health authorities, giving your regulatory filing the strongest possible foundation.
Tech Transfer
06
A Seamless Transition From Your Facilities to Ours.
We manage every aspect of technology transfer with complete documentation, thorough risk assessment, and your team integrated at every critical milestone.
cGMP Manufacturing
07
Where Programs Become Medicines.
We deliver GMP-compliant manufacturing across drug substance and drug product with the precision, consistency, and regulatory credibility every program deserves.
Did you know manufacturing in Australia could fund nearly half your program?
Learn More
Drug Substance Manufacturing Track Record
0+ years
of cGMP manufacturing experience
0
Critical Observations
3
BLA Submissions
0+
products manufactured
Ready to Start Your Microbial Program?
Every microbial program starts with a conversation. Our team is ready to understand your requirements and find the right path forward.