Outsourced Pharma White Papers
-
Development And Regulation Of Veterinary Monoclonals
2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
-
COGs Process Economics For Autologous Cell Therapy
8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.
-
Optimization Of Hydrogen Peroxide Decontamination
6/6/2022
Understanding critical influencing factors of hydrogen peroxide bio-decontamination is key for reliable process parameters.
-
Is Mannitol Hemihydrate Detrimental To Protein Stability?
12/8/2023
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
-
The Promise Of PCM: Getting To Maturity
9/19/2023
PCM offers a number of advantages, including streamlined development and increased flexibility. Review the key drivers for PCM as well as the hurdles that stand in the way of industry-wide adoption.
-
Fc-fusion Cell Line Development: Expression And Analytical Strategies
5/15/2023
Understand high titer expression of Fc-fusion proteins using the Apollo™ X platform coupled with integrated quality assessments, enhancing support through the predicted growth in Fc-fusion clinical applications.
-
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.
-
Overcoming Challenges In AAV And LV Viral Vector Manufacturing
12/5/2023
Manufacturing viral vectors leaves sponsors vulnerable to high costs, delays, and the possibility of failure. The right CDMO partner can help you reduce timelines and costs for viral vector production.
-
Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development
6/1/2022
Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.
-
The Medicines Of Tomorrow: A Primer On The Gene Editing Landscape
8/8/2023
Learn about the distinction between gene therapy and gene editing, as well as the therapeutic potential of CRISPR treatments and the challenges associated with clinical trials and commercialization.