Biopharma­ceutical end-to-end solutions

End-to-end solutions in the context of the biopharmaceutical industry are primarily based on single-use technologies, which allow for the greatest flexibility and agility.

The single-use technologies based on RoSS® are a combination of integrated platform systems, sterile consumables and auxiliary services to achieve process excellence in commercial GMP handling of small volumes or bulk drug substances.

End-to-end Fluid Management Solutions

In an extremely complex, competitive and constantly evolving sector like the biopharmaceutical industry, end-to-end solutions offer a comprehensive and elaborate logistics approach, at the same time ruling out risks of incompatibility and potential product loss or other damages caused by human error.  

They facilitate safe and reliable logistics processes for highly valuable and sensitive drug substances. Thanks to their flexible nature end-to-end solutions allow for stringing together several process steps, as needed, without subjecting the substances to any form of contamination risk. 

As opposed to standalone “silo” platforms, end-to-end solutions can be adapted and scaled to meet specific manufacturer or lab needs.

It is high time to let go of said silo mentality that is still predominant in so many areas and industries. It is time to increase rationalization processes and to eliminate the risk of product loss. The industry requires comprehensive, intelligent and cutting-edge systems to cover the entire cycle all the way. This includes primary packaging to protect the product throughout its journey and to minimize the risk of contamination.

RoSS.FILL Lab Scale offers unprecedented filling accuracy

Advanced Fluid Management & Cold Chain for Small Volumes

The single-use technologies based on RoSS® are a combination of integrated platform systems, sterile consumables and auxiliary services to achieve process excellence in commercial GMP handling of small volumes down to 1mL.

RoSS.FILL Base_Product Photo-7

Advanced Fluid Management & Cold Chain for Large Volumes

The single-use technologies based on RoSS® are a combination of integrated platform systems & sterile consumables for handling of up  bulk drug substances.

Safe and reliable logistics

In an extremely complex, competitive and constantly evolving sector like the biopharmaceutical industry, end-to-end solutions offer a comprehensive and elaborate logistics approach, at the same time ruling out risks of incompatibility and potential product loss or other damages caused by human error.  

They facilitate safe and reliable drug substance logistics processes for highly valuable and sensitive drug substances. Thanks to their flexible nature end-to-end solutions allow for stringing together several process steps, as needed, without subjecting the substances to any form of contamination risk. 

As opposed to standalone “silo” platforms, end-to-end solutions can be adapted and scaled to meet specific manufacturer or lab needs.

It is high time to let go of the predominant silo mentality and implement effective processes to eliminate the risk of product loss. The industry requires comprehensive, intelligent and cutting-edge systems to cover the entire cycle all the way.

Risk of human error and faulty equipment

As is the case in pretty much every sphere of life, the residual risk of human error remains one of the main challenges. Human errors can have far-reaching repercussions.

Several studies confirm that a high number of CMOs and biopharma manufacturers keep filling their products manually - or that they outsource filling altogether - with both cases offering a lot of space and potential for human error and contamination.​1​

However, it is not only human errors but also faulty equipment that can have enormous consequences for biopharmaceutical companies.

If a batch is lost due to contamination - irrespective of whether it was caused by mishandling or faulty equipment - the manufacturer will likely suffer significant financial losses, but, even more fatally, this can lead to dire consequences for the patient relying on the specific medication.

Flexible and agile development, production and logistics processes

Based on the idea of maximum elasticity, Single Use Support have reinterpreted basic production and logistics steps to offer flexible and agile solutions to the biopharma industry.

Our end-to-end fluid management solutions for Bulk Drug Substances or for Small Volumes comprise of a portfolio of logical process steps that connect upstream, downstream and fill-finish to enable a safe and secure transport of high-value drug substancse from the manufacturing area to the patient.

The solution: Different platforms for different needs

Whilst the process solution for bulk drug substances enables labs and manufacturers to store and ship valuable high-quality substances of larges volumes in a secure and reliable manner, all solutions are scalable and can be applied in the process manufacturing of low volume batches in cell and gene therapies.

In line with the definition of end-to-end and its inherent single-use architecture, all platform technologies offer the option to be adapted. Be it by adding a number of optional components such as filtration systems or by scaling up/down to larger/smaller volumes and batches.

Data sheets

Click here to download case studies and information for our end-to-end solutions.

eBook_Filling Gaps in Managing Large Volume of Biologics_Single Use Support

eBook: Filling Gaps in Managing Large Volumes of Biologics

Filesize: 3.99 MB – Mime-Type: application/pdf

Case-Study_062020_ensuring_end-to-end-sterility

Case Study - Ensuring end to end sterility

Filesize: 0.58 MB – Mime-Type: application/pdf

Scalability Guide RoSS.pFTU

Freeze & Thaw Scalability Guide

Filesize: 0.83 MB – Mime-Type: application/pdf

More information

Click here to download case studies and information for our end-to-end solutions.

End-to-end Solution

Single-use end-to-end solutions - flexible, scalable and reliable

In an extremely complex, competitive and constantly evolving sector such as the biopharmaceutical industry, flexibility is key, not least since it is an immensely varied and compliance-driven field. Learn more in this article!

micheal-eder

Michael Eder

June 2, 2021

End-to-end Solution

The call for industrial end-to-end solutions in Biopharma has been heard

Irrespective of what industry we are talking about, the term end-to-end solution describes a principle that takes a system or service – from beginning to end – and delivers a complete functional solution.
 

micheal-eder

Michael Eder

September 28, 2020

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