Elevating cGMP Biologics Manufacturing
At BioCina, we specialise in cGMP clinical and commercial manufacturing across a spectrum of modalities, including microbial, pDNA, and mRNA. When it’s time for you to scale-up, we have the capabilities you need to reach the next milestone. From pre-clinical through to commercial manufacturing scales, our state-of-the-art facilities are equipped to deliver your program on-time and in-full every time. With our commitment to industry leading operational excellence and unwavering dedication to regulatory compliance, BioCina is the choice for an elevated biologics manufacturing experience.
Where Experience Meets Advanced Infrastructure
BioCina is ready to support your evolving needs, with an expert team and state-of-the-art facility, that serves our clients from early-stage development to full-scale commercial manufacturing. Our cGMP manufacturing capabilities span a wide range of scales utilising both stainless steel and single-use technologies. Our cGMP manufacturing processes are underpinned by robust microbial control and multiproduct processing strategies that ensure the highest quality cGMP drug substance for our clients. Entrust your program with BioCina, where experience and advanced infrastructure converge to meet your unique demands.
Comprehensive Manufacturing Services for All Phases
BioCina’s expertise covers every phase of your journey. We offer customised services from technology transfer, to cell line development, to clinical and commercial manufacturing. Count on BioCina to fulfill your clinical and commercial manufacturing requirements in our US FDA approved cGMP manufacturing facility.
cGMP Equipment and Technology to Meet Your Needs
BioCina’s state-of-the-art cGMP facility is equipped to deliver highest quality microbial products:
- Stainless steel fermentation up to 500 L and single-use fermentation
up to 300 L - Midstream processing equipment including continuous flow centrifugation and high-pressure homogenisation
- Refolding capacity up to 3,000 L
- Downstream purification equipment includes AKTA™ Isocratic and AKTA™ Gradient Chromatography skids
- UNIFLUX™ and Repligen tangential flow filtration systems
Manufacturing for Your Biologics Needs
Microbial
Featuring a hybrid manufacturing model with both stainless steel and single-use fermenter systems for DS production, in a single highly integrated facility.
Plasmid DNA
cGMP manufacturing capabilities go up to 500 L, cell lysis and downstream processing equipment customed-scaled to meet your clients needs.
mRNA
End-to-end cGMP manufacturing of LNP encapsulated mRNA, including cell line development and cGMP manufacture of template plasmid DNA.