Cytotoxic / High Potency
As an end-to-end provider of pharmaceutical manufacturing solutions, BioCina is equipped to supply broad cytotoxic and potent drug production services. The highly sensitive and complex nature of manufacturing these compounds means only world-class facilities and experienced staff can be entrusted with their care. We have an unrivaled 30+ year track record for quality and safety and take the utmost care to prevent even the slightest oversight from compromising patients and caregivers, your reputation or business success.
BioCina offers multi-format dosing capabilities in ready-to-use plastic vials. Strong history of approvals and licenses to supply to over 70 countries
- Ready-to-use liquid formulations in polypropylene plastic vials
- Vial fill volumes range from 1mL to 100mL
- Wide range of batch sizes from 15L to 1,180L
- 5M+ unit capacity
- Clear and amber vials
- Aseptic and terminal sterilization
- Filling of oxygen sensitive products
Oncology capabilities are delivered using:
- Dedicated Oncology area (labs & manufacturing) is self-contained within the larger facility
- Restricted Access Barrier System (RABS) filling lines
- Complete visual inspection performed by highly trained operating personnel
- 24×7 operating capacity (three shifts/day)
Comprehensive Services for Your Every Need
Quality &
Regulatory
We produce mRNA drug substance of the highest quality standards, in full compliance with all global regulatory requirements.
Process
Development
BioCina’s expert Poly Nucleic Acid Products team is equipped to develop end-to-end mRNA manufacturing processes up to 1 L IVT and 1 L LNP encapsulation scale.
Analytical
Development
Robust and compliant test methods are developed to ensure the quality, safety and efficacy of all products manufactured at BioCina.
cGMP
Manufacturing
End-to-end cGMP manufacturing of LNP encapsulated mRNA, including cell line development and cGMP manufacture of template plasmid DNA.
Technology
Transfer
Our highly structured approach, including comprehensive gap analysis and robust risk mitigation, ensures reliable technology and process transfers.
Our Expertise On Demand
Thought Leadership & Resources
