Aseptic Development and Manufacturing Capabilities
From early development through to GMP clinical manufacturing, Arcinova delivers end to end aseptic drug product services, combining specialised processing and sterile fill expertise to accelerate your parenteral programme from candidate selection to clinical trials.
Aseptic filtration and sterile fill expertise
Phase I/II clinical manufacturing (FIH & ADME)
Flexible solutions for IV, SC, and IM delivery
MHRA-licensed GMP facility
Sterile Formulation Development
We design high-performance sterile formulations for injectable products, optimised for stability, bioavailability, and delivery route. Our expertise in complex and sensitive molecules ensures your formulation is robust, effective, and ready for clinical progression.
Aseptic Processing & Fill
We deliver precise, GMP-compliant aseptic processing and fill services, from sterile filtration through to final fill. Supporting a range of clinical supply formats, our controlled processes minimise contamination risk and ensure consistent, high-quality output.
Routes of Administration
We support intravenous (IV), subcutaneous (SC), and intramuscular (IM) delivery, tailoring each formulation to the needs of your therapy and target patient population.
The Benefits of Partnering with an Aseptic CDMO
Accelerate time to clinic with established infrastructure and proven expertise
Reduce risk through validated sterile processes and quality systems
Ensure regulatory compliance with cGMP standards
Access specialist technologies without capital investment
Arcinova: Your Partner for Advanced Aseptic Manufacturing
Our services are optimised for early-phase agility, helping you move efficiently into clinical studies.
Proven Expertise in Complex Programmes
- Extensive industry experience: 30+ years of expertise in parenteral drug development, supporting a wide range of innovative programmes.
- Specialist radiolabel and ADME capabilities: Deep expertise in ¹⁴C radiolabelled compounds and human ADME studies, enabling highly specialised development pathways.
- Advanced handling of complex products: Proven capability in manufacturing Investigational Medicinal Products (IMPs), including radiolabelled compounds, high-potency APIs, cytotoxic products, and controlled substances.
Quality & Compliance You Can Trust
- Purpose-built cleanroom environments: Grade A and Grade C facilities with continuous environmental monitoring ensure consistent product quality and full regulatory compliance.
- High-assurance aseptic processing: Advanced Grade A isolator technology delivers complete operator-product separation, significantly reducing contamination risk during fill/finish operations.
- Proven control and monitoring systems: Integrated viable and non-viable monitoring, unidirectional airflow, and EU GMP Annex 1 alignment support reliable manufacturing of complex and sensitive sterile products.