Outsourced Pharma White Papers
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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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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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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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Advancing API Development With Aseptic Manufacturing And Processing
5/16/2024
Delve into the complexities of API sterilization and gain insight from best practices and the critical role of expertise in maintaining sterile production environments.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing
2/9/2024
Learn how strict laboratory practices and routine testing for mycoplasma contamination using nucleic acid-based assays can help ensure safe, high-quality biopharmaceutical products.
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Why Should CDMOs Adhere To The New CDER's Rating System?
5/16/2024
Delve into the FDA's Quality Management Maturity (QMM) program’s benefits, the rating system’s evaluation criteria, advantages and challenges, and steps to overcome these hurdles and achieve excellence.
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Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
2/15/2023
The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
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Biosafety Testing And Quality Control Requirements For Lentiviral Vectors
9/26/2022
Learn more about manufacturing principles of LV vectors as well as testing requirement regulatory considerations with a particular focus on the replication competent virus assay and infectious titer assay.
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Designing A Disinfectant Study For Your Cleanroom
6/13/2024
Review valuable insights into disinfectant expiration, surface selection for testing, risk assessment for study scope determination, and the overall design of this crucial study.
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Safety, Containment, And Analysis Of Highly Potent Compounds
5/16/2024
Explore a comprehensive overview of the challenges, requirements, and best practices for safely working with highly potent compounds in drug development and manufacturing.