Expertise
Modality commandTechnical proficiency across complex modality platforms and their chemistries: mAbs, mRNA/LNP, high-potency ADCs, and small molecules.
Sterile drug product CDMO for the most complex modalities.
Metheus Bio is as much a software company as a CDMO. For high-potency ADCs, mRNA-LNPs, mAbs, and other complex modalities, a bespoke software stack unifies our people, equipment, and process into one data-driven system that spans development, scale-up, and commercial supply. It is built to collapse timelines, give sponsors real-time visibility, and take the friction out of these complex programs. Whether it’s DAR and aggregation for an ADC or encapsulation efficiency and polydispersity for an LNP, that means faster process design and iteration, cleaner tech transfer, and a shorter path to clinic and commercial.
Software
Purpose-builtA proprietary orchestration stack, engineered specifically for complex modality manufacturing and advanced continuously as the science moves.
Analytical
In controlWe build the analytical and control strategies with you, keeping your core modality chemistry elegant, controlled, and quick to advance. Never outsourced.
Delivery
Always onNo chasing one person or team for a status update. Your project runs on live, always-available data, so decisions happen fast and nothing stalls on coordination.
Why we’re different
Fewer hand-offs. Fewer errors. Faster batches.
Every CDMO says it uses software. The difference here: ours is built and run by an in-house engineering team, purpose-fit to how we operate — not a rigid system bolted onto manual work. The coordination that normally causes deviations and delays is designed out, so your material — precious, expensive, often one-of-a-kind — is executed right the first time, with full visibility the whole way.
Capabilities
A fully integrated CDMO for complex modalities.
We don’t just fill your product into vials, syringes, or cartridges. From bioconjugation and process development through analytical, fill-finish, lyophilization, and commercial packaging, we run the whole chain in-house and embed with your team from the early days, so your ADC, LNP, mAb, peptide, or small molecule reaches market fast and right.
Develop with us
Bioconjugation & process design
We embed with your team from the early days, developing the conjugation and drug-product process and designing the scale-up that builds the ADC, LNP, mAb, peptide, or small-molecule process you need.
Fill formats
Vials, syringes & cartridges
Aseptic filling across Type I vials, prefilled syringes, and cartridges, from clinical batches through commercial supply.
High containment
Dedicated OEB6 ADC suite
A dedicated ADC suite with full segregation of HVAC, warehousing, and material and waste flows, engineered to handle the most potent products down to OEB6.
Lyophilization
Dedicated high-potency & standard lyo
A dedicated lyophilizer for high-potency ADCs alongside standard lyo for non-potent or shared programs, so potent and non-potent work never cross.
Analytical & microbial
In-house, per modality
Analytical and microbial capability in-house, complemented to each modality and covering the popular chemistries and platforms, so nothing waits on an outside lab.
Packaging
Commercial secondary packaging
Secondary packaging to match your fill format, closing the loop from drug substance to finished, market-ready product.
Modalities
Built for the high-value, hard-to-fill.
The scarcest capacity sits in the most demanding modalities. That’s where a purpose-built, software-native line earns its place.
Antibodies
mAbs & bispecifics
Low-shear, single-use filling for shear- and aggregation-sensitive antibodies, including high-concentration subcutaneous formats, with tight subvisible-particle and aggregate control across vials, syringes, and cartridges.
Nucleic acids
mRNA / LNP
We hold particle size, PDI, and encapsulation efficiency across thaw, filtration, and fill: inline DLS particle sizing through sterile filtration, RNase-controlled closed single-use paths, and cold chain down to −70 °C.
Conjugates
ADC & high-containment
DAR and DAR-distribution control with HIC polishing, interchain-cysteine and site-specific conjugation, and free-drug clearance, run in a segregated, light-protected suite contained to OEB6 (below 0.1 µg/m³).
Beyond
Complex & specialty
Oligonucleotides such as GalNAc-siRNA and antisense, cytotoxic small molecules, and other high-value injectables that need specialist handling. Bring us the molecule others make you queue for.
From day one
Software-native
Connected systems built into how we operate — not bolted on afterwards.
End-to-end
Clinical → commercial
Small & large molecule, including complex and high-containment.
On record
Transparent terms
Fixed, predictable commercial terms designed around sponsor outcomes.
Work with us
Let’s build your capacity.
We partner with sponsors who need reliable aseptic drug product services for complex modalities: capacity reservations, technical collaboration, and a team that treats your program like its own.