Biosimilars Development Learning Center

 
 
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Biosimilar Manufacturing


Biosimlars Development Learning CenterConsistent, reliable performance is the key to biosimilar drug development and accelerated scale-up to clinic – and that means choosing a partner who understands your challenges of accelerated process development, high product quality, and process economics.

Our approach is comprehensive/holistic process integration to deliver a scalable, robust process that meets today’s rigorous regulatory requirement using the most innovative products for high yield, productivity and maximized product economics.

Flexible facilities with single-use technologiesCost Effective Biosimilars Manufacturing

Biosimilars are a cost competitive market. Pricing may have a direct impact on market share, and return on investment. It is important to have a robust and cost effective process. New high-density cell culture processes, such as concentrated perfusion, and flexible facilities with single-use technologies can help you cope with the rising cost pressures you face.

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  • Single-Use Technology Enables Flexible Factories, BioProcess International, June 2016
    Download to read more on how single-use technology will help design modular facilities to maximize savings, and increase robustness of mAb processes.

  • Watch our webinar “Advanced Perfusion Processes: Design Criteria and Strategies” to know how new high-density cell culture processes, such as concentrated perfusion, present suitable solutions to facilitate a shift toward single-use technologies.

  • Watch our webinar “The Chronicles of a Biosimilar Production Facility” to learn more about designing and constructing a single-use production facility.

Virus Process DevelopmentQuality Biosimilars Process Development and Manufacturing

According to global regulatory standards, a biosimilar molecule must have the equivalent or better product quality and impurity profile. Let us help you design and optimize your process. We can even advise you or develop your analytics.

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Virus Safety

Viral safety of your process.

  • Viral inactivation
  • Virus filtration
  • AEX chromatography
  • Viral clearance service

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Provantage® Services

Consistent molecule quality across scale.

  • Bioreactor
  • Cell culture media
  • Harvest/Clarification
  • Lab solutions
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Quality Raw Materials

Our portfolio of approximately 400 Emprove® raw materials help you meet regulatory requirements.


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Biosimilar Drug Development: A team working together.Speed Up Your Biosimilar Drug Development

Your to-do list is long and not getting any easier. Whether it’s accelerating your biosimilar pipeline to market, increasing productivity, improving process economics, all of the above or something else, there’s a new way.

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Glycosylation Control Technology

Speed your Biosimilar Development using Glycosylation Control Technology from SAFC.Speed your Biosimilar Development using Glycosylation Control Technology from SAFC.

Access comprehensive solutions specifically designed for accelerated development of biosimilars with high titers and cell viabilities as well as enhanced control over glycosylation profiles.

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Provantage® Services

We can help you:

  • Design, develop, optimize, validate, and troubleshoot upstream and downstream processes.
  • Design and validate your own single-use facility
  • Manufacture your GMP material
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Tech Transfer

Biosimilars move around the globe. We can help you transfer you biosimilars process within your facilities or to your partners.

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Training

Check out our professional courses in applications and GMP training offered at facilities around the world.

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mAbRegulatory News

The complex process of creating a generic version of a biologic has resulted in regulators defining the replicate drug as similar, but not identical, resulting in the globally accepted term “biosimilar”.

Learn More about Regulatory Authority Guidance



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