Cytotoxic High Potency Sterile Manufacturing Services
As a trusted cytotoxic CDMO, BioCina delivers end-to-end solutions for high potency sterile manufacturing, supporting the safe and efficient production of complex oncology therapies. Our facilities are purpose-built for high potency handling, incorporating advanced containment systems and specialized environments to ensure operator safety and product integrity. With over 30 years of experience in sterile manufacturing, we combine technical expertise with rigorous quality standards to manage the unique challenges of cytotoxic compounds. From early development through to commercial production, BioCina provides scalable, GMP-compliant manufacturing solutions designed to protect patients, caregivers, and your product throughout the entire lifecycle.
Cytotoxic Sterile Manufacturing Capabilities
BioCina provides advanced cytotoxic sterile manufacturing capabilities designed for safe handling, containment, and scalable production of high potency compounds.
- Ready-to-use cytotoxic liquid formulations in polypropylene vials
- Flexible vial fill volumes from 1 mL to 100 mL
- Scalable batch sizes for clinical and commercial supply, from 15L to 1, 180L
- High-capacity sterile manufacturing (>5M unit capability)
- Aseptic and terminal sterilization options
- Handling of oxygen-sensitive and high potency products
High Potency Cytotoxic Oncology Manufacturing Environment
BioCina’s cytotoxic CDMO capabilities are purpose-built for oncology drug manufacturing, combining high potency containment, advanced sterile manufacturing systems, and strict GMP compliance.
- Dedicated cytotoxic manufacturing suites designed specifically for oncology products with full containment systems
- Restricted Access Barrier Systems (RABS) supporting aseptic filling of high potency oncology therapies
- Fully isolated environments for safe handling of cytotoxic and high potency compounds
- Complete visual inspection performed by highly trained personnel
- 24/7 sterile manufacturing operations to support clinical and commercial oncology supply
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.
Cytotoxic Manufacturing Insights & Resources
Explore insights, case studies, and innovations in cytotoxic and high potency sterile manufacturing.
Partner with a Cytotoxic Sterile Manufacturing CDMO
Work with BioCina’s experts in cytotoxic sterile manufacturing to deliver safe, scalable, and compliant high potency production solutions.