Our Quality and Regulatory Experience Provides the Foundation for Success
Our highly tenured quality and regulatory teams with their deeply rooted experience provides your biologic product with the foundation for long term success. With roots planted by Pfizer, our people have personally walked the path from research and development through commercial manufacturing and because we understand the journey you’re on, we approach your program like it’s our own.
As your reliable CDMO partner, we ensure the success of your programs every step of the way because we understand your commitment towards the wellbeing and safety of patients. Partner with BioCina and see your life’s work progress.
Elite Quality at Every Step
Quality is a culture at BioCina. It is core to every aspect of all of our services.
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 Impeccable Quality & Regulatory Track Record
Our quality & regulatory track record is unrivalled – proven by no observations of any kind in the previous four regulatory inspections. Since the facility’s original licensing by the TGA in 2004, we have consistently satisfied all compliance and regulatory standards for GMP certification. We are the only biologics CDMO in Australia with a facility that’s been approved by the US FDA, EMA, and Health Canada for product launch.
With our global regulatory inspection track record, your program is in right hands.
Assuring Quality and Compliance Through Our Comprehensive Services
Our Quality team consists of highly committed individuals, deeply experienced in Quality Assurance, Quality Compliance, Quality Control, Analytical Services, and Validation. Automated Quality Management System (eQMS) is in place, to ensure compliance with all global regulatory standards. With our automated, flexible, and efficient training methods, we ensure our team members are up to date on Chemistry, Manufacturing, and Controls (CMC) guidelines required for development of your programs.
We ascertain the characteristics and profile of all the products we manufacture for our clients, ensuring the standards required for cGMP clinical and commercial manufacturing are compliant. Working closely with our analytical development team, our quality control team provides a full suite of testing, monitoring, and characterisation services for the microbial, pDNA, and mRNA modalities. Our capabilities include:
- In-process and release lot testing
- Method transfer and phase appropriate method validation
- Stability testing
- Reference material development and qualification
- Process validation support
Quality in Every Offering
We can successfully develop and manufacture your microbial product, from clinical stage to commercialisation, ensuring a robust and scalable process that maintains the highest product quality.
Our pDNA platform is designed to produce highest quality plasmid products for all applications across all phases.
We produce mRNA drug substance of the highest quality standards in full compliance, with all global regulatory requirements.