Mobius® Formulation and Fill

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With new therapies on the horizon, clinical runs are increasing and the majority of these new drugs have smaller lot sizes and highly potent ingredients. Traditional fill finish operations have their own set of productivity challenges that can limit filling flexibility and the needs of this changing market. Mobius® single-use final fill solutions are easily implemented to meet today's increasingly complex drug production demands. Single-use delivers greater process flexibility and productivity, increase operator and product safety as well as reduce validation requirements and process turnaround time. Whether you need to convert your current infrastructure or build a new one, Mobius® final fill solutions can meet your needs.

For more information about our single-use assembly shelf life validation, packaging and sterility services, contact your local representative.

With Merck as your sterile filtration partner, you will have the peace of mind that comes from working with the industry leader who has over 50 years of expertise in sterile filtration with market leading Durapore® (PVDF) and Millipore Express® (PES) membranes.

All Mobius® single-use containers are made with our PureFlex™ and PureFlex™ Plus single-use films ensuring consistent performance throughout your process as well as streamlining validation requirements. Our BioReliance® Validation Services laboratories provide GMP testing to support the validation of filters and films.

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Mobius® Final Fill Solutions

Mobius® single-use final fill assemblies provide the flexible filling productivity that allows you to respond to the demands to manufacture a variety of drug products and fill volumes. With new therapies on the horizon, clinical runs are increasing and the majority of these new drugs have smaller lot sizes and highly potent ingredients. Traditional fill finish operations have their own set of productivity challenges that can limit filling flexibility and the needs of this changing market.

Mobius® final fill assemblies are easily implemented to meet today's increasingly complex drug production demands. Single-use delivers greater process flexibility and productivity, increase operator and product safety as well as reduce validation requirements and process turnaround time.

• Safety, efficiency, cost reduction
• Decrease risk of cross contamination
• Eliminate cleaning requirements
• Reduce set-up time
• Reduce validation
• Increase filling productivity
• Reduce time to market
• Decrease filling line bottlenecks by retrofitting existing hard piped systems with a single-use solution

Smart Thinking from Mobius®
Integrating a single-use final fill operation can reduce your campaign fill time by 75%. We have results demonstrating a 36 hours to 12 hours reduction from initial clean and set up to final fill at 10,000 fills per hour.

How to Implement Single-use Final Fill

Experts from the Mobius® team work with you to determine your specific fill fill requirements. The result: a single-use final fill system that’s ready to use out of the box, featuring modular, fully optimized assemblies. The assemblies are connected to create a disposable system that adapts easily to the needs of your specific filling requirements, using only what is needed for that specific fill volume. These systems are replicable, scalable and facilitate technology transfer across multiple sites.

As the cutting edge biotech companies develop new molecules, rapid drug commercialization requires fast, efficient technology transfer across multiple sites.

Closed System Filling Transfer Set to Isolator

Click image to enlarge.

Mobius® Single-Use Final Fill Assemblies are constructed with the same materials of construction used by all our Mobius® single use products from upstream through downstream.

To learn more, view our Webinar on The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems.