Scaling bioprocesses while minimizing CMC risk

Successful chemistry, manufacturing, and control activities streamline drug development without compromising quality or efficacy

Access expertise early on and de-risk process milestones

Manufacturing novel biotherapeutics poses complex challenges that can make it difficult to meet milestones without taking on unexpected risk. You need a robust process, a secure supply chain, and a way to minimize production deviations so patients receive high-quality therapies each time. Early design choices can affect your overall speed to market. Build your expertise with ours.

Process development Introduction

Manage raw materials   |   Scale-up   |    Process development resources    |   Application solutions

Accelerate your process from bench to trials

It is not straightforward to scale molecules to meet regulatory and patient demand. While you’ve mastered the science of therapeutic innovation, we’ve mastered the art of bioprocessing, with decades of experience taking companies from start-up to clinicals trial and commercial success. Together, we can help you reduce risk and make good decisions faster.

Optimizing upstream process efficiency

Best practices cell and gene therapies  

  

Process development resources

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Scaling up bioprocesses through a CDMO

Roivant Sciences and Cytiva’s Fast Trak services collaborate to accelerate an orphan drug to clinic.

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Scaling a mAb process to 1000 L

Translating monoclonal antibody production from microscale to 1000 L.

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Moving from non GMP to GMP

Transferring a process from a laboratory-scale idea to GMP-compliant commercial product.

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Lentiviral vector scale-up

Simple batch process scales in linear manner from 5 L to 28 L in single-use bioreactors.

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Speeding upstream process development

Process intensification and other approaches to increase efficiency.

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CDMO technology transfer success

Don’t risk reducing the quality and efficiency of your process during handoff.

  

Application solutions

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mRNA Manuacturing

Learn more about key considerations and strategies in mRNA manufacturing workflow.

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Protein production

Upstream, downstream, and analytics support to take you from idea to pure characterized product.

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Cell processing

Technologies to close, automate, and digitize your cell therapy process for consistent and scalable production.

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Gene therapy

Flexible, scalable solutions to help you quickly add capacity to develop and manufacture your own plasmids and viral vectors.

Adenovirus

Viral vaccine production

Manufacturing approaches for novel vaccines to include vaccines that are bacterial, virus, protein polysaccharide or DNA-based.

Downstream process development

Accelerate process development

Balancing innovation, speed, and robustness to support biotherapeutic production.

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