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 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.

Understanding The Fill Finish Process for Your Drug Product

 

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.

 

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
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Our Formulation & Development Services Offering

 

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.

  • 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 as well.

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Our Clinical & Commercial GMP Manufacturing Outsource Solution

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.

  • 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 process 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
  • Personnel 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.

  1. Protein Structure & Stability
  2. Difficulty with the levels of viscosity
  3. GMP regulations and adherence to compliance when shipping & packaging
  4. Temperature fluctuations during transport (that must be secure)

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 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.

Click here to contact us today.