In close collaboration with GE Healthcare, Fujifilm Diosynth brought online the UK's first cGMP single-use manufacturing facility in just 14 months. Discover how Fujifilm Diosynth assessed its options and the secrets to their success.

Manufacturing needs

Understand how your new manufacturing capacity addresses industry needs




Local requirements

Understand the local operating environment and regulatory requirements

Technology platform

Choose a reliable, robust and flexible technology with supporting control systems

Future-proofing

Ensure your capacity is flexible, can be modified and supported into the future




Supplier capabilities

Choose a quality and proven supplier with a broad solution offering

Assess manufacturing needs

In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspect of the drug development lifecycle you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.

Understand local requirements

If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital.

Evaluate technology platform

In deciding which single-use platform to choose, reliability and robustness are fundamental requirements. Beyond process performance, it is important to consider how control systems and automation come into play, how easy it is to implement the platform, and if the design is flexible enough to support varying production volumes.

Determine supplier capabilities

Expanding biomanufacturing capacity is a complex process, requiring expert input from a wide range of disciplines. Choosing a supplier with a strong quality and supply track record, as well as broad technology platform and deep bioprocessing expertise, will simplify the entire process.

Plan for the future

You have to be thinking about how you can modify and future-proof your biomanufacturing capacity to ensure it remains flexible to meet future needs, rather than just focusing on the short term. Beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure long-term success.

GE Healthcare – contact us

Marlborough, Massachusetts
100 Results Way
Marlborough, MA 01752
Main: + 1 800 526 3593
cs-us@ge.com 

Uppsala, Sweden
Björkgatan 30
SE-751 25 Uppsala
Sweden
Main: +46 18 612 0000
productse@ge.com 
Fujifilm Diosynth – contact us

College Station, Texas
100 Discovery Drive
College Station, TX 77845 
Main: +1 979 431 3500

RTP, North Carolina
101 J Morris Commons Lane
Morrisville, NC 27560
Main: +1 919 337 4400

Billingham, United Kingdom
Belasis Avenue
Billingham
TS23 1LH
United Kingdom
Main: +44 1642 363511

Read insights from biopharmaceutical manufacturers and industry thought leaders on single-use technology. Download the e-book - Evolve with flexibility: Advancing single-use technology with industry collaboration

See how single-use technologies compare to stainless steel when expanding biologic manufacturing capacity. Review key variables to consider for capacity expansion with single-use.

Learn about the environmental impact of single-use versus stainless steel. Read the white paper - An environmental life cycle assessment comparison of single-use and conventional bioprocessing technology.

Discover how GE Healthcare’s extractables and leachables policy aligns with the BPOG protocol – read the white paper.

Learn how to make bioprocessing faster, more efficient, and economical – view GE Healthcare’s single-use portfolio for the bioprocess spectrum