OP White Papers - random
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A Scalable Single-Use Two-Step pDNA Purification Process
3/6/2024
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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β-Glucan As A Process-Related Impurity In Biopharmaceuticals
5/17/2022
In this white paper, we dig deeper into the sources of β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.
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Intro To USP <1062> - What It Is And Why You Should Use It
7/20/2023
Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.
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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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Collaborating With A CMO To Bring Your Sterile Injectable Product To Market
2/15/2023
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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CRISPR RNPs And The Future Of Cell And Gene Therapy
4/21/2023
Explore the potential of ribonucleoprotein (RNP) to deliver CRISPR materials more accurately, efficiently, and effectively, as well as the manufacturing challenges which require further attention.
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Can Yeast Be The Future Of Efficient Subunit Vaccine Manufacturing?
9/11/2023
To aid in the manufacturing of new vaccines, Pichia pastoris yeast, a promising protein expression system, could be the perfect solution.
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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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Next Gen Plasmid Technology: Improve Performance, Safety, Manufacturing
1/17/2023
Nanoplasmids have paved the way for facilitating a wide range of cell and gene therapeutic applications. Gain an overview of a novel technology and specific benefits.
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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.