INSIGHTS ON DOWNSTREAM MANUFACTURING

• Three Key Factors In Supporting Rare Disease Clinical And Commercial Drug Product Manufacturing

  The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for their drug product manufacturing.

• Evaluation & Application Of Amsphere A3 In Downstream Purification Processes

  This webinar reviews the results of comparisons of the Amsphere A3 resin to other high-performance Protein A resins available.

• Multi-Column Capture Chromatography

  Continuous capture chromatography allows for improved resin capacity, through continuous loading of multiple columns in series, reducing cost of goods. Read more about a multi-column capture (MCC) system developed and utilized for a project in this application note.

• Designing Successful Viral Clearance Studies

  Despite careful testing of starting materials and in-process intermediates, there is still a risk that a virus could enter the manufacturing process undetected. Here, we review the studies which involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step and measuring the virus remaining after the process step.

• Scaling From Cell Factory™ Systems To An iCELLis® 500 Bioreactor Without Affecting Critical Quality Attributes

  12/20/2021

  The challenge was to identify an effective, replicable, and large-scale lentiviral vector (LVV) manufacturing process to meet the growing manufacturing demand – especially for market application – without affecting critical quality attributes.

• Developing Next Gen mAb Process Using 3M Solutions

  12/16/2021

  Improvement in downstream bioprocessing is available by leveraging new process designs that allow replacing multi-use steps with single-use solutions. Learn more about how 3M solutions enable acceleration of downstream workflows.

• 3M Virus Clearance Conquers mAb Solutions

  12/16/2021

  Implementation of innovative filtration technologies in GMP manufacturing processes have been hindered by several factors such as poor binding capacities and understanding of viral clearance mechanisms. Hear how 3M™ Polisher ST helps meet strict viral clearance requirements.

• Replacing Chromatography Column At Scale

  12/16/2021

  Biopharmaceutical companies operating in a manufacturing environment with columns are approaching the limits of productivity and scalability. Hear how 3M’s single use technology can help reimagine process design.

• Replacing Column Performance To Achieve Simplified And Cost-Effective Process

  12/16/2021

  Learn more about this innovative solution that utilizes a proprietary membrane protected by a polypropylene non-woven material to achieve a simplified and cost-effective process that could replace AEX by 2030.