AbbVie’s Aseptic Fill Finish Solution
We offer two convenient fill finish options for parenteral drug products: vials and pre-filled syringes. As a leading pharmaceutical partner, we can provide all necessary elements of delivering high quality parenteral products for clinical and commercial needs.
AbbVie leverages its know-how and proven quality, regulatory, and operational network to help you achieve your milestones through comprehensive development and manufacturing support for your vial and syringe drug product formulations.
Understanding The Fill Finish Process for Your Drug Product
Fill-finish is arguably the most critical step in the overall drug manufacturing process. It comes after upstream bioprocessing — the formation of the active agent by a cell culture or fermentation — and downstream purification.
Fill-Finish is a relatively mature, primarily industrial activity, concentrating on efficient product formulation and packaging. Fill-finish, much more than bioprocessing, involves complex mechanical engineering filling, fluid and solid dispensing, and sealing systems.
In aseptic fill finish a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering (or closing) of a container happens after this step, with the exception of when a drug requires sterile lyophilization.
It is important to note the criticality of these later-stage development processes. More specifically in a fill finish process, innovation quite possibly can be a silent killer. However, in fill- finish even the smallest of mistakes can lead to a production failure and an overall loss with an already expensive product.
This is one of the main reasons why AbbVie CMO aims to use tried-and-true industry processes during our aseptic fill finish solution in our end-to-end drug manufacturing.
Vial & Prefilled Syringe Fill Finish Offerings
- Liquid and Lyophilized vial options from 2R to 20R vial formats
- Fully automated isolator line with potent containment handling to <10ng/m
- 23M² auto load lyophilizer
- Pre-filled syringes in tubs with validated fill volumes from 0.4–2mL
Our Formulation & Development Services Offering
Our formulation & development capabilities have been built with the best scientific minds over several decades and remain as pillar examples of excellence in the contract manufacturing industry.
Meanwhile, globalization and an increase in pharma counterfeit incidents and/or errors are prompting the industry to tighten regulations on production and supply chain.
To that extent, establishing preventative measures and systematizing regulations have become major issues for many pharmaceutical companies.
- Extensive formulation and scale-up experience at all phases of development
- Lyophilization process optimization, scale-up, and technical transfer
- Lab-scale filler and lyophilization capable of 10–500 vial feasibility batches
- Optimize the lyophilization cycle and cake quality
- Minimize development cost via fewer engineering runs at scale
- Aseptic Fill Finish Considerations Throughout Your Drug Lifecycle
Manufacturing Equipment and Process Capabilities
At AbbVie CMO, we leverage our extensive experience to give your product an inside edge. Our vast knowledge is based on our own extensive history of commercial success allowing us to apply that experience to find the right solution that is tailored to meet your product's needs.
Our state-of-the-art manufacturing facilities are located in both the US and Europe.
Along with these tried-and-true processes, we also employ the best manufacturing equipment and technology available.
Challenges Companies Face When Completing an Aseptic Fill Finish Solution
Aseptic processing is uniquely challenging because it requires careful planning, thoroughly trained personnel, and specialized facilities/equipment to properly execute. Some common challenges include:
- Protein Structure & Stability
- Difficulty with the levels of viscosity
- Utilization of valuable drug substance
- GMP regulations and adherence to compliance when shipping & packaging
- Choosing the Right Partner for Aseptic Fill Finish Drug Manufacturing
Choosing the Right Partner for Aseptic Fill Finish Drug Manufacturing
Our team's extensive clinical and commercial experience with drug product manufacturing allows for a seamless transition at any stage while ensuring all levels of global compliance. We have the expertise as a leading global pharmaceutical organization to anticipate all potential challenges and carefully plan your project to ensure successful patient outcomes.
For more information about our Fill Finish outsourcing services or next steps to get started outsourcing your drug product today, contact us here for further details.