Insights On Downstream Manufacturing
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Addressing The Challenge Of Scalability In Viral Vectors
10/18/2020
Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs. In this webinar, you will learn the importance of planning for scalability and manufacturability from the earliest stages of process development and how a scalable templated process can reduce time needed to move from product development to commercialization.
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Accelerate Viral Detection
10/18/2020
How to accelerate viral detection from weeks to just days? This one-minute video introduces you to Blazar™ Platform. This rapid molecular platform combines the speed and sensitivity of PCR with the breadth of detection normally associated with Next-Generation Sequencing. A highly multiplexed degenerate PCR approach allows broad and sensitive detection of viral contaminants.
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Introducing The Series 4000™ Single Round Filter Housings
10/13/2020
Reliable filter housing design to meet all your biopharmaceutical filtration needs. The Series 4000™ Filter Housings are available in T-line and in-line designs, with a wide range of tube sizes. All configurations are available and ready to be shipped to your location!
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Mobius® Chrom 20 System, For Purification Of Clinical And Process Scale Biologics
10/13/2020
Our unique clamshell and single-use Flexware® clamshell assemblies offers ultimate ease of use.
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Choose A CDMO Partner That Integrates Market Intelligence For Aseptic Fill And Finish
10/13/2020
Today, a plethora of contract development and manufacturing organizations (CDMOs) provide aseptic fill/finish services around the world. However, to offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering.
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Cell Therapy Scale-Up Strategies For Commercial Success
9/30/2020
To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.
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Developing A Closed Connected Single Use mAb Purification Process
9/28/2020
Pharmaceutical manufacturers are striving for more diversified portfolios targeting a greater number of monoclonal antibodies (mAb), the key to driving down overall costs is to lower capital expenditure (CAPEX) investments by better utilization of equipment. This article provides an overview of a successfully designed a closed and physically connected mAb process at the pilot scale with single-use components.
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Robust Process Development For cGMP Manufacturing Of Cell Therapies
9/24/2020
By leveraging early decisions around process development, quality assurance, and quality control strategies, you can set yourself up for a successful cGMP manufacturing workflow.
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Security Of Supply In Cell And Gene Therapy Manufacturing
9/24/2020
With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.
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Aseptic Filling Operations: In-House Or Outsourced?
9/23/2020
Why pouring millions into the infrastructure and quality systems necessary to move away from manual filling is unrealistic and minimizes your value as a drug developer.