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Services

Aseptic Fill Finish

AbbVie long track record of quality control, strict regulatory compliance, and operational excellence, allows us to complete the manufacturing process by filling your product into sterile syringes or vials ready for market. Fill-finish manufacturing is one of the last steps in pharmaceutical commercialization. The goal is efficiency and sterility. The foes are waste and poor quality control. 

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The Final Touch

Excellence in packaging. Results at scale.

AbbVie CMO is one of a few global CMOs with the expertise in ADC contract manufacturing to streamline production processes and supply chains and coordinate all facets of your ADC production, from the monoclonal antibodies and conjugation with the linker-toxin.

Working with AbbVie Contract Manufacturing means partnering with a proven innovator and market leader who is focused on fast-tracking your drug development program to completion and facilitating sustained market success. We are one of only a few CMOs globally with the capabilities and experience to develop and deliver the entire comprehensive antibody drug conjugates (ADCs) supply chain.

Our state-of-the-art facility and expert team in Worcester, Massachusetts, are able to streamline your production processes and supply chain. Leveraging program stability, a unified quality and operational network to coordinate all facets of ADC production including monoclonal antibody (mAb), linker-toxin and conjugation across our global network.

AbbVie Contract Manufacturing performs aseptic fill finish with highly tuned efficiency on purpose-built machines that maximize output and quality, while eliminating waste and contamination. AbbVie then implements rigorous fill finish analytical screening and quality control. 

Fill-finish is a mature industry and leaders must distinguish themselves through efficiency and safety in product manufacturing and end-product packaging. Aseptic fill finish processing is uniquely challenging because it requires careful planning, thoroughly trained personnel, and specialized, sterile facilities/equipment. Only AbbVie has the experience and expertise to deliver results at scale. 

With AbbVie CMO, our partners gain access to the most advanced aseptic fill finish manufacturing processes, people, facilities, and global reach. Let’s talk … about AbbVie CMO’s fill finish services or next steps in outsourcing your drug product today.

AbbVie’s Aseptic Fill Finish Solution

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 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.

Prefilled Syringe & Vial Fill Finish Offerings

  • Liquid filled vials
  • Lyophilized vials
  • Pre-filled syringes
  • Small volume parenteral
  • Large volume parenteral
  • An extensive range of vial sizes including ISO standard vials
  • Aseptic-fill

Our Formulation & Development Services Offering

Our formulation & development capabilities that 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
  • Computational Fluid Dynamic modeling
  • Differential Scanning Calorimetry for understanding critical product temperatures
  • Lab-scale filler and lyophilization capable of 10–500 vial feasibility batches
  • Method development and phase appropriate qualification

Given these efforts, AbbVie continues to implement and exceed industry standards responding with the latest advances in cold chain storage.

Our Clinical & Commercial GMP Manufacturing Outsource Solution

Leverage AbbVie CMO’s experience to give your product an inside edge. Our vast knowledge is based on commercial success applied to find the right solution that is tailored to meet your product's needs.

Our state-of-the-art manufacturing facilities are located in the both 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.

  • Bosch aseptic 6 head filling line with peristaltic pump technology
  • Liquid fill and lyophilization capabilities with 23m2 automated lyophilizer
  • Equipped for 2R, 6R, 10R & 20R with capability from 2R to 50R
  • OEL <10ng/m3 for potent containment requirements 
  • Single-use fluid path designed for low line loss
  • 100% headspace analysis, visual and semi-automated inspection
  • Full analytical capabilities including biologic, chemical, micro, stability and container closure testing

Download Our Aseptic Fill-Finish Fact Sheet Today

Lyophilization optimization, scale-up, & tech transfer processes include:

  • Computational fluid dynamics (CFD) for modeling to GMP lyophilization for seamless tech transfer
  • Differential scanning calorimetry (DSC) and Freeze Dry Microscopy (FDM) for understanding critical product temperatures
  • Optimize the lyophilization cycle and cake quality
  • Minimize development cost via fewer engineering runs at scale
  • Aseptic Fill Finish Considerations Throughout Your Drug Lifecycle

Drug Product Components

  • API usage
  • WFI usage
  • Sterilization Type
  • Container Systems
  • Cleanroom Facilities

Equipment Type & Process

Personal Training & Technique

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:

  • Heat Sterilization: The most widely used sterilization method
  • Radiation Sterilization: A component is exposed to electromagnetic radiation
  • Filter Sterilization: A method wherein a component is dissolved in WFI
  • Ethylene Oxide Gas Sterilization: A method used mainly to sterilize bulk API powder

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

  • Protein Structure & Stability
  • Difficulty with the levels of viscosity
  • GMP regulations and adherence to compliance when shipping & packaging
  • Temperature fluctuations during transport (that must be secure)
  • Choosing the Right Partner for Aseptic Fill Finish Drug Manufacturing

Choosing the Right Partner for Aseptic Fill Finish Drug Manufacturing

In the forever-changing manufacturing industry, businesses consistently find themselves exceeding the production capabilities that they have planned for in-house.

Inevitably, resources 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 adherence with all levels of global compliance.

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 align directly with the success of your product. Successful projects are pivotal to the overall happiness and longevity of the 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.

An AbbVie CMO representative is eager to talk to you.

AbbVie CMO is a seasoned partner for all your contract manufacturing needs. Let’s start a conversation today. The future is a click away.

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