OP White Papers - random
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Using Next Generation Sequencing Methods For Virus Vector Identity Testing
9/7/2022
Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Learn what advantages NGS offers for obtaining accurate sequences.
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Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?
9/5/2023
Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.
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Remote Access And Monitoring Of Bioprocess Unit Operations
5/26/2022
Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.
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Extended Head Flats Increase Dwell Time
4/25/2024
Explore the extended head flat and how this punch modification can improve the compression of difficult formulations.
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Establishing Analytical Methods For mRNA-Based Therapies
6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Digital Transformation: A Critical Component For CDMOs
6/21/2023
Learn how embracing the digital transformation is key for managing complexity of speed, service, quality, regulatory compliance, and capacity as well as the obstacles facing CDMOs looking to innovate.
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A Molecule’s Journey: Break Down Roadblocks To Clinical Success
7/13/2023
The key to a biopharma executive's success is making the right decisions at the right time. Which will get your biologic to the clinic quickly and cost-effectively, without compromising quality and patient safety?
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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State-Of-The-Art Bispecific Antibody Development
10/11/2022
The promise of bispecific antibodies stems from their off-the-shelf nature and ability to bind to two or more different targets or epitopes, thereby performing multiple functions.