Seed Train Intensification

Cell culture intensification as shortcut in upstream processing

At the very early stage of biopharma drug substance manufacturing, the cell banking during upstream processing (USP) in biopharma manufacturing, cells are being nurtured from 1 mL to more than 2000 L within approx. 5 weeks. There are many potential pitfalls in terms of sterility and appropriate cell perfusion when it comes to growing cell lines to their full potential.
Seed train intensification is a way to circumvent the continuous “back to start” with 1 mL and to benefit from the already expanded cells into bioreactors.

SEED.STREAM, the process solution by Single Use Support for advanced seed stream intensification, describes the next generation of cell culture intensification.  This process includes end-to-end qualification during filling, freezing, thawing and draining of drug substance at all scales. 

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Process Control in Seed Train Intensification

Automation, process control and high cell density cryopreservation in order to secure protection and sterility by process in a closed system. The advanced process strives to 

  • avoid manual handling
  • reduce environmental requirements at the manufacturing site
  • accelerate the speed of production
  • simplify the operation in-plant 
  • save huge operation costs during repetitive upstream

If you want to be on the safe side when growing a beautiful flower, you’d also rather plant seedlings instead of casting seeds.

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Primary Packaging

RoSS.PADL

Feed Source for Aliquotation

Single-use aseptic bag filling machine RoSS.FILL

Automated Aliquotation

Protection for small single use bags CGT with RoSS.KSET

Protect

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Controlled Rate Freezing

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Ultra-Cold Storage

Shipping drug substances in single-use bag containers safely with RoSS.SHIP

Transportation

Lab freezer for pharma with RoSS.pFTU lab scale

Thaw

Primary Packaging

IRIS Single-Use Bag (2D or 3D)

Store and ship anything from cell culture samples to large drug substance volumes reliably and on time. 2D or 3D single-use bioprocess containers in any size.

Single-use bioprocess container by Single Use Support

Feed Source for Aliquotation

RoSS.PADL | HOMOGENIZING SOLUTION

RoSS.PADL is a platform to standardize cooling of your single-use bag whilst gently massaging it to ensure a homogeneous mixture of your substance.

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Automated Aliquotation

RoSS.FILL CGT

Fully automated filling system for multiple small single use bags at highest accuracy. Applicable for both, cell & gene therapies and Upstream Seed Train Intensification.

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RoSS.FILL Bag

With RoSS.FILL Bag, the RoSS shell systems contained in the rack are filled with a speed of up to 200L per hour in a fully automated manner. RoSS.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks.

RoSS.FILL - single use bag and bottle filling and filtration system machine

Protect

RoSS.KSET

With either RoSS or RoSS.KSET, the sensitive single use bag can be protected as intermediates in Seed Train Intensification. It is covered in 3D foam on the inside and stainless steel on the outside - ideal for controlled freezing process and absolutely robust.

CGT bag protection and safe logistics with RoSS.KSET by Single Use Support
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RoSS® Shell

With the RoSS Shell system, the sensitive single use bag is covered in 3D foam, which is held by a highly robust plastic frame. Bottom and top are made of stainless steel - ideal for the freezeing process and absolutely robust.

Single use bag protection for drug substances in bulk stream with RoSS shell by Single Use Support

Controlled Rate Freezing

RoSS.LN2F | Liquid Nitrogen Freezer

RoSS.LN2F is a powerful cryogenic controlled rate freezer for temperatures down to -180°C/-292°F. An enclosed and innovative platform system for dosed freezing for cell and gene therapies enables no direct exposure, and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.

RoSS LN2F cryogenic freezer
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RoSS.pFTU Lab Scale

Controlled freezing and thawing of small batches - more important than ever for seed train intensification. The plate-based freeze & thaw platform for labs RoSS.pFTU Lab scale is the perfect solution for cell culture intensification in intermediates of one or multiple single use bags of up to in total 5L. GMP-compliant computerized system optional.

Laboratory freezer RoSS.PFTU Lab Scale
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RoSS.pFTU Large Scale

The freeze & thaw system RoSS.pFTU is a fully automated and scalable plate-based freezing unit. Both economically and in terms of product stability we have reached the next level. The plate-based platform RoSS.pFTU Large Scale is completely adapted to RoSS shell system for a batch sizes of 240L and more.

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Ultra-Cold Storage

RoSS.FRDG

Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.

Ultra-cold storage RoSS.FRDG

Transportation

RoSS.SHIP | Smart Cold Chain Shipping Container

RoSS.SHIP secures the cold chain storage and shipping of bulk drug substance for almost one week. With its Smart Tracking & Tracing Add-on you never loose control of your product.

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Thaw

RoSS.pFTU Lab Scale

The plate-based platform for controlled freezing and thawing small batches, RoSS.pFTU Lab Scale, is the perfect solution for cell culture intensification in intermediates of one or multiple single use bags of up to in total 5L. GMP-compliant computerized system optional.

Laboratory freezer RoSS.PFTU Lab Scale
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RoSS.pFTU Mid Scale

RoSS.pFTU Mid Scale is a plate-based freeze-thaw unit for studies and small scale batches. Thawing different individual volumes of drug substance up to 70 L with ease. Based on plates, the freezing and thawing time is controlled and rapid.

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More information

Seed.Stream - Seed train intensification the next big step biopharma

Seed train intensification - the next big step in biopharma?

Labs and manufacturers feel the pressure to deliver at a constantly accelerating pace while remaining flexible. In this article, you will learn how Single Use Support can bring you to the next level!