GMP Manufacturing
Xcellon Biologics offers GMP manufacturing capabilities in Maryland. Our facility extends the same science-driven approach used in development including our glycoengineering conjugation platform and platform DSP purification into a GMP environment for clinical supply.
Why Programs Choose Xcellon?
Most tech transfer risks occur when development and GMP processes are misaligned. By building a US-based GMP operation around the same technologies used in our development workflows, Xcellon provides a smoother, lower-risk path into the clinic, all under one roof.
What We Offer
- Cell banking
- Cell culture
- Downstream purification
- Bioconjugation
- Drug substance bulk fill
- QC testing
- Stability study
Capabilities
- Sartorius rocking bioreactor
- Sartorius 200L bioreactor
- 2x Sartorius 1000L production bioreactor
- 3M & Millipore depth filtration system
- Cytiva ÄKTA Process skid
- Cytiva ÄKTA Ready XL skid
- Segregated bioconjugation suite with HPAPI containment
These capabilities will be the natural extension of ADC development services and bioprocess development, supported by analytical and formulation development and monitored with advanced data analytics.
Plan ahead for GMP supply with Xcellon
FAQs for Manufacturing
Our GMP facility in Maryland will be operational in Q4 2026.
We will focus on ADC and bioconjugate clinical supply, fully integrated with our development workflows. We will also provide manufacturing services for antibodies, multi-specifics and other complex biologics.
Engaging with us early through our CRO services, ADC and process development services, formulation and analytical services, ensures a seamless transition once GMP manufacturing is available.
