Biosimilar White Papers
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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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.
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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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Five Essentials For Accurate Oligonucleotide Chemistry
3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Inspection Of Injectable Products For Visible Particulates
8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
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The Dynamic Regulatory Environment Of Drug-Device Combination Products
11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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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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Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development
12/27/2023
Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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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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Taking Charge Of Your Stability Program
10/5/2022
Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.