Esco Aster is the first in Southeast Asia (ASEAN) to provide small-batch aseptic fill-and-finish services post-sterile filtration for further manufacturing, final drug products and for terminal sterilisation with in house autoclave that are fully compliant with USP <1207> container-closure integrity testing.
Esco Aster fill & finish follows phase-appropriate GMP standards, supporting GLP toxicology material for GLP Tox Studies, vaccine challenge studies, clinical trial supply, and small commercial lots for both human and animal health. Our filling solutions also include filling of placebos as part of randomized clinical trial studies and diluents.
As part of our end-to-end service offering, Esco Aster either receives the bulk drug substance that is produced as well in our cGMP facility for immediate fill & finish or from our long term storage.
We can also receive bulk drug substance and carry out cGMP thawing as well as sterile filtration if required before proceeding to fill & finish.
Esco Aster has expertise as well specifically in exosome formulations that can be provided as part of overall offering (hyperlink to page). | Esco Aster and as part of exosome bulk drugs substance cGMP Extracellular Vesicles Contract Manufacturing for Therapeutic Applications | Esco Aster.
Esco Aster can provide an all-encompassing formulation exosome to drug product development service including fill and finish of exosomes, secretomes and extracellular vesicles across various disease areas from orthopedics to dermatology medical aesthetics and cancer oncology therapy including bispecific exosomes.
Esco Aster offering also includes aseptic process simulation with advanced filling technologies to ensure sterility and precision. Our semi-automated 3P multi-format system supports vials ranging from 2R to 30R, alongside cartridges and syringes, enabling flexible solutions for diverse clinical and commercial needs.
Before contract fill-and-finish begins, aseptic process simulations (media fills) are performed to qualify that the developed process can be executed in a sterile and compliant manner thereby complying to FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (2004) and PIC/S standards.
Controlled Environment
All fill-and-finish activities are conducted in a Grade A stainless steel Biological Safety Cabinet with continuous viable and non-viable monitoring, within a Grade B NEBB-certified cleanroom inside our cGMP facility.
Our fill-and-finish capabilities are designed to meet diverse clinical and commercial needs:
- Semi-Automated 3P Multi-Format System
- Throughput: Optimized for clinical batches at 2–3 units per minute
- Vials: Support for 2R to 30R formats; compatible with Type 1 glass and advanced polymers including COP (Cyclic Olefin Polymers) and COC (Cyclic Olefin Copolymers)
- Cartridges: Standardized for ≥3 mL
- Syringes: Standardized for 1–3 mL
- Weight Verification: Integrated 100% In-Process Check (IPC); every container weighed to ensure compliance with fill-volume specifications
- Aseptic Cryogenic Filling
- FillXcell system for cryobag and cryocontainer filling
- Cryovials/Cryotubes: High-accuracy electronic pipetting for precise small-volume filling
Container Closure Systems
We provide flexible closure solutions to support both liquid fills and lyophilization cycles:
- Stoppering & Lyophilization Support
- Partial stoppering for freeze-drying cycles
- Full stoppering for liquid fills
- Modular platform adaptable for vacuum stoppering
Sealing Options
- Rotary crimping with aluminum flip-off seals for robust hermetic closure
- Press-fit integration for “one-step” closure solutions, including Daikyo PLASCAP® and RayDyLyo®
Esco Aster with our in house Msat and processing engineering teams can also provide a bespoke custom engineered fill & finish solution in other formats contact us if you have a specific need.
Visual Inspection
Following filling, Esco Aster performs visual inspection with qualified inspectors who undergo rigorous in-house training based on client-specific defect libraries, often developed under contract during drug product process development.
Container-Closure Integrity Testing (CCIT)
Post visual inspection Esco Aster carries out 100% container closure integrity testing for small batches based using a PTI Veripac 465 using a ASTM F2338-09 Triple Cycle Vacuum Decay method that detects molecular, micro and large leaks. Esco Aster multi-cycle approach prevents excessive contamination of test chamber in case of leaks & aborts test cycle when leak is detected.
Container-Closure Integrity Testing can also be provided as a standalone service and is applicable for the following containers formats
- Vials (Liquid filled, Lyophilized, Glass/Plastic)
- Syringes (Empty, Prefilled)
- Cartridge*
- Ampoules
- Ophthalmic dropper
- IV bags & liquid filled pouches
- Lidded (Non-porous pouches)
- BFS (Blow-Fill-Seal)/ FFS (Form-Fill-Seal)
- BPC (Bulk Pharmaceutical Chemical) containers
- API (Active Pharmaceutical Ingredient) containers
*For Cartridge, due to the minimum head space, the detection limit is around (10 um)
Labelling and Storage
Once inspection is complete, cGMP-compliant labelling is applied, typically followed by controlled-rate freezing and interim storage in quarantine ultra-low temperature freezers or liquid nitrogen tanks. After contract testing confirms compliance, a Certificate of Analysis (CoA) or Certificate of Compliance is issued, and the drug product is transferred from quarantine into qualified storage with 24/7 monitoring and redundancy, ready for shipment to clinical trial sites or long-term storage.
Regulatory Track Record
Esco Aster has a US FDA track record for the fill-and-finish for use in Phase 1 clinical trials in the USA.
Why Choose Esco Aster
Esco Aster is the first in Southeast Asia to deliver integrated fill-and-finish services for advanced therapy medicinal products (ATMPs). Our phase-appropriate GMP compliance ensures seamless support from GLP toxicology material through to clinical trial supply and small commercial lots. By keeping container-closure integrity testing, stability programs, and quality control in-house, we shorten timelines while maintaining rigorous oversight.
Our proven regulatory success with US FDA-regulated clinical trials demonstrates our ability to meet the highest global standards. Flexible manufacturing systems accommodate diverse container formats and fill volumes, while end-to-end traceability through controlled documentation provides confidence in product integrity and regulatory readiness.