The Global Biologics CDMO That’s Always Ahead of Your Needs
We help our partners accelerate to market.
Our Vision
To be the most client-centric and reliable Biologics CDMO, accelerating therapies to market and enriching the lives of all stakeholders.
Our Mission
We provide everything clients value the most.
We keep our commitments through unrivaled quality and industry-leading on-time and in-full delivery, every step of the way.
Our Offerings
Our deeply tenured teams are here to bring your ambitions to life. We provide scientific and operational excellence from process development through the cGMP clinical and commercial scale manufacturing of microbial, pDNA and mRNA-based vaccines.
Microbial
Bacterial protein expression platforms for all types of microbial products, including whole cell vaccines.
Plasmid DNA
Process development and bulk cGMP DNA adjuvants and plasmids, pDNA for vaccines, cell and gene therapies and templates for mRNA production.
mRNA
Messenger RNA for preclinical research, toxicology studies, clinical trials and commercial production for mRNA therapeutics and vaccines.
Our Services
We deliver on-time and in-full for our clients every step of the way from idea to end product. We’re always inspection-ready and provide unmatched service with all the intangibles that make our client relationships stand the test of time.
Technology Transfer
Regardless of where your product is in its lifecycle, we’ll optimise your process and accelerate your path forward. With our standardised tech transfer procedures, robust quality systems, and dedicated project management team, every batch gets the best. Throughout, we provide the right combination of knowledge and skill required to successfully scale-up your product and process to move your program forward.
Process Development
The process is the product and we’ll ensure your process is optimised, for reliable and scalable manufacturing. By leveraging our extensive experience across numerous modalities, we offer critical input on the strategy, design, and development of your process to expedite timeline, minimise risk, and reduce cost. We work closely with you to develop robust, commercially viable processes that can be seamlessly transferred from pre-clinical to commercial scale.
Analytical Development
BioCina combines method transfer, development, qualification, and validation into an integrated analytical method lifecycle service offering, rather than treating them as separate elements. We develop analytical methods for microbial, plasmid DNA and mRNA programs.
cGMP Manufacturing
When it’s time to scale-up, we have the capacity and capabilities you need to reach the next milestone. From pre-clinical 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 operational excellence and assurance of regulatory compliance, let us accelerate your program to market.
Quality and Regulatory
We offer services in compliance with regulations and guidelines from the most stringent regulatory authorities. We provide a phase appropriate quality approach that earns the trust of our clients through all phases of our client programs, comprising of clinical trials, validation studies and product approvals.
Our Four Differentiators
Deeply Rooted
BioCina’s Roots
Run Deep
Our highly tenured operational and technical teams draw upon their elite industry experience to give your biologic product the foundation it needs to flourish. Quality is embedded in our culture and is core to every aspect of the services we provide to our clients, and we are the only biologics CDMO in Australia that’s been approved by the US FDA. Partner with BioCina and see your life’s work progress.
Like Our Own
We Approach Your
Program As A Partner
Our people have personally walked the path from research and development through commercial manufacturing. Because we understand the journey you’re on, we approach your program like it’s our own. We bring passion that can’t be trained, earn trust through collaboration, and build long-term relationships founded on respect. When you partner with BioCina, every batch gets the best.
We Deliver
You Deserve A CDMO That
Keeps Its Commitments
And that’s very difficult to find. BioCina does what it says it will – every step of the way. On-time and in-full delivery is an obsession for us. When combined with our always inspection ready quality and compliance and our unmatched approach to partnering, our client relationships stand the test of time.
Peerless Value
Our Value Is More
Than A Proposition
It’s inherent to who we are. BioCina’s strategic location in Australia affords clients accelerated timelines to clinical trials and preeminent R&D tax incentives, ensuring faster payback on investment. Combined with dominant performance across quality, timeline, capacity, and capability, we provide everything clients care about most. Partner with us and get peerless ROI.
We're Growing for You
At BioCina, growing to ensure we meet the evolving needs of our current and future clients’ isn’t a goal, it’s a given. Our state of the art facilities are manufacturing the medicines of tomorrow and we always stay ahead of emerging technologies and rising market needs.
We are the only US FDA approved biologics CDMO in Australia and we continue to grow our global footprint from that strong foundation.