Drug Product: Aseptic Fill & Finish

Esco Aster is the first in Southeast Asia (ASEAN) to offer small-batch fill-and-finish services supported by USP <1207>–compliant Container–Closure Integrity Testing (CCIT). Our capabilities include aseptic fill-and-finish of post–sterile filtered final drug products as well as fill-and-finish followed by terminal sterilisation using our in-house autoclave, ensuring consistent sterility assurance and product quality.

Esco Aster’s fill-and-finish operations follow phase-appropriate GMP standards, supporting the manufacture of materials for GLP toxicology studies, vaccine challenge studies, clinical trial supplies, and small commercial lots for both human and animal health. Our capabilities also include the filling of placebos and diluents as part of randomized clinical trial studies.

As part of our end-to-end service offering, Esco Aster can receive bulk drug substance manufactured within our own cGMP facilities for immediate fill-and-finish operations or long-term storage prior to fill-and-finish at a later stage, based on client requirements. We also accept externally manufactured bulk drug substance and perform the cGMP-compliant thawing and sterile filtration, when required, prior to fill-and-finish.

Esco Aster has the expertise specifically in exosome formulation development and exosome drug product development, which can be integrated seamlessly into our overall manufacturing services. We provide a comprehensive exosome formulation to drug product development services, including formulation and fill-and-finish of exosomes, secretomes, and extracellular vesicles (EVs) across a wide range of therapeutic areas — from orthopedics and dermatology/medical aesthetics to oncology, including advanced modalities such as bispecific exosomes.

Our offering also includes aseptic process simulation (APS) supported by advanced filling technologies to ensure sterility and precision. Esco Aster’s semi-automated 3P multi-format fill-and-finish system supports vials ranging from 2R to 30R, as well as cartridges and syringes, providing flexible, scalable solutions for diverse clinical and small-commercial manufacturing needs.

Before contract fill-and-finish activities begins, aseptic process simulations (media fills) are conducted to qualify that the developed process can be executed in a sterile and compliant manner, in alignment with FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP (2004) and PIC/S requirements.

All fill-and-finish activities are performed in a Grade A stainless steel Biological Safety Cabinet (BSC) with continuous viable and non-viable environmental monitoring, housed within a Grade B, NEBB-certified cleanroom in our cGMP facility. This controlled environment ensures consistent sterility assurance throughout operations.

Our fill-and-finish capabilities are designed to support a wide range of clinical and small manufacturing requirements.

• Throughput: Optimized for clinical batches at approximately 1–3 units per minute
• Vials: Supports 2R to 30R formats; compatible with Type I glass and advanced polymer containers, including COP (Cyclic Olefin Polymer) and COC (Cyclic Olefin Copolymer)
• Cartridges: Standardized for volumes 1.5–3 mL
• Syringes: Standardized for 1–3 mL
• Weight Verification: Integrated 100% In-Process Check (IPC), with every container weighed to confirm compliance with fill-volume specifications

• FillXcell™ system for cryobag and cryocontainer filling
• Cryovials and cryotubes: High-accuracy electronic pipetting enables precise small volume filling under aseptic conditions

We offer flexible container-closure solutions to support both liquid-filled products and lyophilized drug products:

• Stoppering and Lyophilization Support
• Partial stoppering for freeze-drying cycles
• Full stoppering for liquid fills
• Modular platform adaptable for vacuum stoppering

• Rotary crimping with aluminum flip-off seals for robust hermetic closure
• Press-fit integration for “one-step” closure solutions, including Daikyo PLASCAP® and RayDyLyo®

In addition, Esco Aster’s in-house MSAT and process engineering teams can provide a custom engineered fill-and-finish solutions in alternative formats. Please contact us to discuss your specific requirements.

Following inspection, cGMP-compliant labelling is applied. Drug products typically undergo controlled rate freezing and are placed in interim storage for quarantine within ultra-low temperature freezers or liquid nitrogen tanks.

Upon successful completion of contract testing, a Certificate of Analysis (CoA) or Certificate of Compliance is issued. Products are then released from quarantine into qualified storage with 24/7 monitoring and redundancy, ready for shipment to clinical trial sites or long-term storage.

Esco Aster has a proven US FDA regulatory track record, with fill-and-finish activities supporting Phase I clinical trials in the USA.

Esco Aster is the first in Southeast Asia to deliver integrated fill-and-finish services supported by container–closure integrity testing for advanced therapy medicinal products (ATMPs). Our phase-appropriate GMP compliance ensures seamless support from GLP toxicology material through clinical trial supply and small commercial manufacturing lots. By maintaining CCIT, stability programs, and quality control capabilities in-house, we shorten development timelines while retaining rigorous quality oversight.

Our successful experience supporting US FDA–regulated clinical trials, combined with flexible multi-format fill-and-finish systems and comprehensive documentation control, provides sponsors with confidence in product integrity and regulatory readiness.