Biosimilar White Papers
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Process Development Considerations For RNA-LNP Therapeutics
9/13/2022
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?
4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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The Latest Trends In The Prevention And Treatment Of Cervical Cancer
2/8/2024
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.
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Data Utilization For Advanced Analytics And Near Real-Time Monitoring
8/16/2022
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing
2/9/2024
Learn how following strict laboratory practices and conducting routine testing for Mycoplasma contamination using nucleic acid-based assays can help ensure the production of safe and high-quality biopharmaceutical products.
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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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A Risk-Based Approach To Injectable Combination Product Development
3/14/2023
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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Navigating The Regulatory Maze: Fundamentals For Drug Development
7/15/2022
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster
3/24/2023
Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
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Validation Master Plan For Filtration Systems Used In Aseptic Processing
1/13/2023
Regulatory guidance provides a framework for aseptic processing that ensures patient safety. Learn about the best practices for validating performance of critical filtration systems used in aseptic processing.