We offer two convenient fill-finish options for parenteral drug products: prefilled syringe and vials. As a leading pharmaceutical partner, we can provide all necessary elements of delivering high-quality parenteral products for clinical and commercial needs.
AbbVie will leverage 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.
Fill-finish is the final manufacturing step (and arguably the most critical) in the overall drug manufacturing process. It comes after upstream bioprocessing, otherwise known as the formation of the active agent by a cell culture or fermentation. It also takes place after 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.
Aseptic fill finish is the area where a sterile drug is transferred from a filling needle to a sterile container, usually a vial or prefilled syringe. Normally, the stoppering (closing) of a container happens after, with the exception when a drug requires sterile lyophilization. It is a critical part of biopharmaceutical manufacturing.
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, since fill-finish is a critical part of the biopharmaceutical manufacturing process, even the smallest of mistakes can often lead to the ultimate nightmare of production failure which equates to an overall loss with an already expensive product.
This is one of the main reasons why we aim to use tried-and-true industry processes during our aseptic fill finish solution. It also brings to life our core message of “Experience Unrivaled” when dealing with AbbVie’s end to end drug manufacturing process.
Our formulation & development capabilities that have been built with the best scientific minds over the past few decades remain as pillar examples of the demand for excellence in the contract manufacturing industry.
Globalization and an increase in the number of 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.
Given these efforts, AbbVie continues to implement and exceed industry standards responding with the latest advances in cold chain storage as well.
Leverage our experience to give your product an inside edge. Our vast knowledge is based on commercial success that we then apply to find the right solution tailored to meet your product's needs.
Our state-of-the-art manufacturing facilities are located both in the US and Europe.
Along with these tried and true processes, we also employ the best manufacturing equipment and technology available.
Our state-of-the-art line supports lyophilization for potent and biologics along with liquid fill vials.
Regardless of the form factor, each individual component of a drug product must be sterilized prior to aseptic processing. There are several FDA-recommended methods to sterilize components:
Aseptic processing is uniquely challenging because it requires careful planning, thoroughly trained personnel, and specialized facilities/equipment to properly execute.
In the forever-changing manufacturing industry, businesses consistently find themselves exceeding the production capabilities that they have planned for in-house.
Inevitably, resources tend to get completely tied up, equipment is overused or not used for its original purpose all resulting in unaddressed production consequences. Our team's extensive experience with drug product manufacturing allows for a seamless transition while ensuring all levels of global compliance are met.
We understand that the best contract manufacturing companies will act like an extension of your team and we are ready to become that resource for your fill finish project. As a result, the overall project goals directly align with the success of your product. Successful projects are pivotal to the overall happiness and longevity of the overall relationship.
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.