We work with batch sizes designed around the what early-phase trials genuinely require, not around the economics of commercial manufacturing real requirements of early-phase clinical trials, providing the flexibility and responsiveness that large-scale commercial manufacturing cannot always offer. Whether you are producing your first GMP batch, transferring a process from another site, or scaling up from development runs, we adapt to the stage and specific needs of your program.
Aseptic GMP Manufacturing
Sterile Fill & Finish Tailored to Your Product Requirements
Aseptic GMP Fill and Finish
Sterile Fill & Finish Tailored to Your Product Requirements
We work with batch sizes designed around the what early-phase trials genuinely require, not around the economics of commercial manufacturing real requirements of early-phase clinical trials, providing the flexibility and responsiveness that large-scale commercial manufacturing cannot always offer. Whether you are producing your first GMP batch, transferring a process from another site, or scaling up from development runs, we adapt to the stage and specific needs of your program.
OUR EXPERTISE
Aseptic fill & finish is one of the most technically demanding stages in drug product manufacturing — the point where contamination control, process precision, and GMP compliance converge, and where the integrity of everything built during development is either confirmed or compromised where contamination control, process precision, and GMP compliance come together to ensure the integrity of everything achieved during development.
At Archivel, we provide the facilities bring the environment, expertise, and the clinical-scale flexibility your program needs, ensuring — so your product reaches the clinic exactly as intended it should.
What molecules do we cover?
Our expertise covers a broad range of biological molecules, including:
Vaccines
Oncologic vaccines
Peptide and Proteins
Antibodies
Cell-derived products
Innovative products
Vaccines
Peptide and Proteins
Cell-derived products
Oncologic vaccines
Antibodies
Innovative products
Aseptic Fill & Finish
At Archivel, aseptic filling is performed in a Grade A environment generated by unidirectional airflow within an open Restricted Access Barrier System (oRABS), housed within a Grade B background cleanroom. Our semi-automated filling line is designed for clinical-scale batch production, covering the full range of primary container formats.
Our aseptic filling capabilities include:
Cleanroom under Annex-1 GMP compliant with positive pressure: Grade A unidirectional airflow via oRABS, within a Grade B background cleanroom
Cleanroom under Annex-1 GMP compliant with negative pressure: Grade A with biosafety cabinets.
Sterilization: Bioburden pre-filtration followed by sterile filtration
Container formats: Vials, syringes, cartridges, and ophthalmic containers
Fill line: Semi-automated, configured for clinical-scale batch sizes
Terminal sterilization in Grade C room: Available for products where the molecule and process allow for it.
Lyophilization
Lyophilization is a proven technology for enhancing the stability of sensitive drug products. By gently removing water under controlled conditions, it preserves biological activity and extends shelf life, enabling products that may not remain stable in liquid form.
At Archivel, lyophilization is fully integrated within our aseptic fill & finish workflow. Our freeze-dryer is directly connected to the filling line within the same oRABS environment — meaning filled containers lyophilized without ever leaving the Grade A zone, eliminating exposure risk and maintaining the sterility assurance built into the aseptic process.
Our lyophilization capabilities include:
Equipment: Lyophilizator operated under full GMP conditions
Cycle development: Full freeze-drying cycle design from scratch, built around your molecule and formulation
Cycle optimization: Adaptation and optimization of existing lyophilization protocols
GMP batch production: Clinical-scale freeze-dried batch manufacturing, fully documented and released ready
Clinical Manufacturing
Our GMP clinical batch manufacturing covers:
Full GMP batch records: Complete manufacturing documentation for every batch, structured for regulatory review and submission
In-process controls & monitoring: Systematic controls throughout the manufacturing process.
Environmental monitoring: Continuous monitoring of cleanroom conditions to validate the aseptic environment.
Clinical Labelling & Secondary Packaging: End-to-end clinical labelling and secondary packaging services ensuring compliance, traceability, and quality.
Batch release by Qualified Person (QP): Every clinical batch is formally certified and released by a qualified person, in compliance with EU GMP requirements
Container Formats & Batch Volumes
At Archivel, our fill & finish capabilities are optimized for clinical volumes, with batch sizes scaling from hundreds to thousands of units depending on your trial requirements.
Container formats:
Vials: 2R, 4R, 6R, 8R, 10R, 20R, and 50R — liquid and lyophilized
Pre-filled syringes: Multiple sizes available
Bottles: Available for ophthalmic and liquid formulations
Dosage forms supported:
Sterile liquid
Lyophilized (freeze-dried)
