MONOCLONAL ANTIBODIES (MABS)

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Safe Handling and Freezing/Thawing of Monoclonal Antibodies (mAbs)

Controlled processes play a vital role for monoclonal antibodies (mAbs) manufacturing processes. mAbs require special care and sensitive handling at every step of development and production, as well as in logistics, so as not to compromise their effectiveness. Additionally, controlled andfast freezing and thawing ratescan add to improved levels of quality and lead to better overall results.

Guide for mAb manufacturing - 5 Most Overlooked Challenges

Guide for monoclonal antibody manufacturing with regards to fluid and cold chain management - 5 Most Overlooked Challenges. In detail:

  • Efficiency in CHO cell expansion process
  • Scalability in fluid management
  • Protein aggregation during mAb freezing & thawing
  • Contamination risks
  • Efficiency in mAb production
Preview of Single Use Support's guide about fermentation

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Guide: Challenges in biopharmaceutical fermentation

Guide about microbial or mammalian fermentation with regards to fluid and cold chain management challenges. In detail:

  • Advanced Bulk Plate Freezing replacing Spray Drying
  • Protection of Bags Reduce Product Loss
  • Scalability in Yeast, Bacterial or Fungal Fermentation
  • Speed of Large Volume Filling and Freezing
  • Integrated End-to-End Logistics in Continuous Production

Learn more to navigate 5 of these most overlooked challenges in this Fermentation Guide.

  • Single-use technologies are highly flexible and scalable; thus, they offer the ideal solution for processing antibodies, cells and genes in a variety of volumes. 

    The growing range of therapies and compounds calls for plants and systems that are or can be adapted to the increased speed of development and production as well as constantly changing requirements. In the case of monoclonal antibodies special focus should be put on viscosity: As a result of protein-protein interactions, concentrated mAb solutions can exhibit high levels of viscosity that may pose challenges during the manufacturing process.

  • Image of a controlled plate freezer loaded with RoSS shells.

The ROI of bulk freezing with plate freezers

The switch from cryovessels to plate-based freeze & thaw single-use technologies is, not least, a matter of costs. To determine the return on investment (ROI), different cost drivers were identified and evaluated. Discover the comparison of cryovessels, blast freezers and plate-based freezers in this case study.

Preview of Single Use Support's case study about the ROI of bulk freezing

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Case Study RoSS.pFTU: The ROI of Bulk Freezing with Plate Freezers

An CDMO aspires to achieve improved freezing control, uniformity, and scalability when freezing BDS. New technologies are meant to reduce the need for manual handling as well as increase process efficiency and throughput. The goal was to evaluate and determine the return on investment (ROI) of cryovessels and plate freezers when freezing bulk.

More information

Evaluating freeze-thaw processes in antibody production

Evaluating freeze-thaw processes in antibody production

Monoclonal antibodies: Improved quality and better results thanks to controlled freezing and thawing In a field as sensitive as biopharmaceutical development and production, controlled processes and procedures have always played a vital role an...

Alexander Fuchs
Alexander Fuchs
Scaling mAb production: From lab to large-scale

Scaling mAb production: From lab to large-scale

Scaling up monoclonal antibody (mAb) production is the pressing challenge faced by many in biopharma today. The need to meet the surging demand for these crucial therapies drives an urgent search for practical, effective solutions. In this arti...

Alexander Fuchs
Alexander Fuchs
Trends in monoclonal antibody production: Optimizing processes with single-use technology

Trends in monoclonal antibody production: Optimizing processes with single-use technology

Monoclonal antibody production is shaped by changing trends and continuous scientific progress. The increasing need for high-quality mAbs for more and more applications require manufacturers to permanently improve production processes. However, it...

Khalil Essani
Khalil Essani