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Aseptic Fill & Finish CDMO Services
True flexibility for your fill & finish needs. We provide aseptic fill and finish solutions supporting both liquid and lyophilized final dosage forms.
Fill & Finish solutions that ensure seamless transition from bulk drug substance to final drug product
This service is available also for:
Overview
From Drug Substance to Drug Product
Fill & Finish is the final step that turns a sterile bulk drug substance into a closed, inspectable and releasable drug product presentation.
53Biologics supports biologics programs that require aseptic filling into vials, bottles or single-use bags, as well as lyophilized presentations where product stability requires a solid sterile format.
What We Offer: A Range of Fill & Finish Possibilities
Aseptic Filling
Aseptic filling for sterile biologic drug products, with Grade A isolator technology and SciLog equipment to fill vials, bottles and single-use bags.
Lyophilized Drug Product
Lyophilization capability for products that require improved stability as a sterile solid presentation. Cycle transfer, execution and project-specific lyophilization support can be scoped according to product knowledge and regulatory stage.
Flexible Container Formats
Support for vials, bottles and single-use bags, including bulk filling where appropriate. We give each program the flexibility to match the final presentation to the product requirements and batch size.
QP Release and Storage
Batch documentation, release testing coordination and storage support from -80 °C to room temperature. QP release support can be included where applicable to the project scope.
Process
End-to-End Fill & Finish Capabilities
01
Aseptic Filling
Controlled filling of vials, bottles and single-use bags in a Grade A / ISO 5 isolator supported by SciLog liquid handling.
02
Lyophilization (Freeze-Drying)
Integrated freeze-drying for biologic drug products that require lyophilized final presentations to improve product stability, shelf-life or storage strategy.
03
Labelling & Packaging
Stoppering, crimping/capping and visual inspection to support batch completion, followed by secondary packaging activities when requested.
04
Storage
Full cold-chain logistics with controlled storage from deep-frozen to room-temperature conditions.
05
Release
Batch documentation and release support to help move the final drug product toward clinical, preclinical or selected commercial use.
Final Dosage Forms We Support
| Dosage form | Fill & Finish capabilities |
|---|---|
| Sterile liquid dosage forms | Aseptic Filling of liquid drug product presentations under a controlled Grade A / ISO 5 isolator and SciLog system. Includes filling into vials, bottles and single-use bags, with appropriate closure systems and full batch documentation support. |
| Lyophilized sterile dosage forms | Aseptic Filling followed by integrated lyophilization for drug products requiring freeze-dried final presentations. Supports stability-oriented dosage forms where the final product is supplied as a sterile lyophilized cake or powder for reconstitution. |
| Capsules | Filling of capsule dosage forms under controlled conditions, supporting oral solid presentations where applicable. Includes encapsulation and packaging aligned with client requirements. |
Why Choose 53Biologics for Fill & Finish
Side-by-Side Drug Product Support
Our team stays involved through the detail, helping your drug substance move into final product with fewer handoffs and clearer technical alignment.
Flexible Formats, Controlled Execution
Liquid, lyophilized, vial, bottle or single-use bag formats can be matched to your product requirements, batch size and development stage, without forcing the program into a rigid model.
Scientific Depth in Drug Product
Aseptic Filling, container choice, lyophilization and storage strategy are guided by technical judgement, helping each biologic move into final product with the right level of control.
Continuity to
Final Product
Fill & Finish is connected with manufacturing, release testing and documentation, helping your program move from drug substance to final product with one accountable team.
Support
Frequently Asked Questions
Common questions about our aseptic Fill & Finish services. Can’t find what you need? Talk to our team.
Which dosage forms can 53Biologics manufacture?
We support aseptic filling of sterile liquid formulations and lyophilized products, with integrated freeze-drying capabilities for biologics requiring enhanced stability. Additional dosage forms may be evaluated depending on project requirements.
Which container formats do you support?
Our Fill & Finish platform supports sterile vials, bottles and single-use bags. Container closure systems are selected according to the product, filling volume and intended use.
Can you manufacture both Drug Substance and Drug Product?
Yes. We provide integrated Drug Substance manufacturing, aseptic Fill & Finish and analytical support under one roof, minimizing technology transfers and maintaining process knowledge throughout the project.
What types of biologics can you aseptically fill?
Our platform is suitable for a broad range of biologics, including plasmid DNA, vaccines, recombinant proteins like monoclonal antibodies, enzymes, and other sterile injectable products. Each project is evaluated individually to ensure compatibility with our manufacturing platform.
What batch sizes do you typically support?
Our semi-automated filling platform is designed for small- to medium-scale batches, making it particularly well suited for preclinical, clinical and orphan drug manufacturing, as well as niche commercial products.
Request a Quote for Your Fill & Finish Project
Tell us about your drug substance and target presentation — our team will get back to you as soon as possible.
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