Cytotoxic and lyophilization
With OEB5 containment, commercial-scale vial filling, lyophilization and integrated packaging capabilities, ROIS is the ideal manufacturing partner for complex cytotoxic and ADC programs.
Complex manufacturing expertise in every dose.
Aseptic manufacturing requires robust equipment, defined processes and technical expertise. ROIS offers the expertise and special handling needed to advance oncology and ADC programs to commercialization for liquids, lyophilized or complex nano-particle solutions.
Cytotoxic and lyophilization capabilities
- Integrated vial filling using IMA Edwards lyophilization
- Automated loading and unloading technology
- Supporting programs from late-phase clinical through commercial supply
- Flexible batch sizes up to 170,000 vials per cycle
4
170,000
15 years
OEB5
The ROIS standard
Partnership
Collaborating with clients as strategic partners, with flexible, adaptable models
Impact
Strengthening the supply of medicine to patients through reliable manufacturing
Integrity
Steadfast standards in every submission, batch and conversation
Responsibility
Operating in a way that demonstrates responsibility to people, communities and the planet
FAQs
ROIS operates four dedicated 45 square meter LyoMax chambers, each fitted with 15 shelves. Batch capacity ranges from 650 vials at minimum to 170,000 vials at maximum per cycle, giving cytotoxic, ADC and biologic programs the flexibility to scale through to full commercial manufacture.
Yes. ROIS integrates lyophilization with sterile fill-finish and OEB5 containment, serving cytotoxic, ADC and biologic injectable programs from a US-based site.
ROIS uses IMA Edwards LUAT automated loading technology (Model ZDE299DC) alongside a Transfer Car system (Model ZDE299DD) and a nitrogen or filtered-air inert gas overlay, maintaining product integrity and consistent output across every batch, from late-phase clinical through commercial-scale manufacture.
ROIS has over 15 years’ experience with heat-sensitive derived nanoparticles; process controls support high particle uniformity and filtration prior to aseptic filling.
ROIS manages OEB5 products through a combination of facility design controls, specialised equipment and robust manufacturing processes. Highly trained teams work within a segregated cytotoxic manufacturing area to ensure safe handling, product integrity and consistent quality throughout aseptic manufacturing.
Explore further
Sterile manufacturing
Packaging and integrated services
Modalities
News and resources
Personalized partnerships. Global reach.
Connect with the ROIS team to explore our cytotoxic and lyophilization capabilities.