Monoclonal Antibodies
Process Development and Application Expertise

Flexible Manufacturing

One size does not fit all when it comes to manufacturing. You need to explore all your options and work with a partner who has the experts and experience to deliver an optimized solution customized for your particular needs.


1. Benefits and Considerations of Single-use Manufacturing Solutions

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While stainless steel installations are often cost prohibitive and time-consuming, adoption of single-use or hybrid systems represent a faster, more flexible and less capital-intensive route. Cost and benefits of each option should be weighed against existing infrastructure, technical constraints and production volume requirements.

Single-use manufacturing systems offer multiple advantages versus traditional stainless-steel equipment:

  • Increased speed-to-market
  • Reduced capital
  • Increased flexibility for facilities with multi-products and batch sizes
  • Reduce cross-contamination risks

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Webinars:

  • The chronicles of a biosimilar production facility
    In this webinar, we will discuss the challenges you face in designing and constructing a single production facility that can produce different biosimilar monoclonal antibodies, from clinical studies through commercial production.

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2. Managing Process Scale-up and Tech Transfer

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  • Managing process scale-up and tech transfer
    Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.

Converting from pilot to process scale and transferring technology requires flawless and seamless organization, communication and documentation. A well-developed technology transfer package:

  • Provides a clear understanding of the process and technologies
  • Determines the appropriate path to achieve goals of the project
  • Aligns with the pharmaceutical quality management system as outlined in ICH Q10

Successful technology transfers include detailed planning of each activity transfer, risk assessment, cGMP training requirements, regulations, process validation, and control strategy.


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  • Process of the future: Cheaper, faster and safer with single-use technologies
    Despite the introduction of new technologies, biotech processes still contain a number of open and at-risk transfer steps. Cell culture transfer from one vial to containers such as T-flasks or shake flasks, and then to the bioreactor, is usually one of these open phases. These critical steps may take several days or even weeks, and can results in delays if a contamination occurs.

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3. Successfully Implementing a Large-scale, Single-use Bioreactor Platform

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Successful implementation of a large-scale, single-use bioreactor platform requires:

  • Demonstration of scalability across the platform — an equivalent performance between the small and large scale
  • Consideration of the footprint constraints and facility design

A number of factors critical to efficient cell growth, viability and protein production must be considered when optimizing bioreactor design including, among others, mixing efficiency, gas transfer capability, mixing time and tip speed.


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4. Meeting the Stringent Requirements of a Final Filling Process with Fit for Purpose Assembly Design

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This series of 3 webinars "Final filling process design considerations" discusses single-use assembly design, and risk mitigation strategies for your sterile filtration process.


Closed System Filling Transfer Set to Isolator

The implementation of single-use technologies for critical applications such as final filling delivers important benefits:

  • Increased flexibility for multi-product filling
  • Reduced risk of cross-contamination
  • Reduced turnaround time between process batches

Single-use technologies, must however, meet stringent requirements for the final filling of the drug product including sterility, integrity, cleanliness, operational safety and efficiency.


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Videos:

  • Choosing the right number of filters
    This vodcast offers design considerations regarding single stage vs. dual stage and redundant filtration.
  • Filters in or out of the isolator
    To learn more about the various risks and benefits when choosing where to put your filter in your final filling process, watch the second part of our Final Fill Design Considerations vodcast series.
  • Flush bag vs barrier filters
    This vodcast helps you understand how a barrier filter can be used to simplify complex integrity testing operations.
  • Stacked vs pleated
    This vodcast discusses the device design characteristics that impact hold-up volume and yield.

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