Outsourced Pharma White Papers

1. Orthogonal Methods To Understand And Define CQAs Of AAV Therapies 2/24/2023

   An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

2. A Five-Point Strategy For Building A CMC Dossier 3/2/2022

   By adopting strategies to build a robust CMC package to help streamline the path to FIH trials, innovators can establish a quality foundation to support the development phases toward commercialization.

3. Nanosuspension Dosage Forms: Product Development & Scale Up 2/8/2022

   For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.

4. PBPK Modelling For Optimizing Controlled Release Dosage Form Development 8/24/2023

   Examine the benefits of controlled release, the application of PBPK modeling in controlled release formulation development, and how modified release products can be developed to deliver optimal patient outcomes.

5. Successful Planning: Process Liquid & Buffer Preparation 6/23/2023

   Gain a deeper understanding of common operational inefficiencies, risks, and financial burdens associated with process liquid and buffer preparation to obtain an accurate total cost of ownership assessment.

6. Outstanding Sensitivity For Confident SPR Interaction Analysis 7/20/2022

   Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.

7. Regulatory Strategy Considerations For Working With The FDA Vs. The EMA 8/8/2022

   This guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.

8. A Molecule’s Journey: Achieve Commercial Manufacturing Success 3/18/2022

   Experts share what they consider to be key considerations for biopharmaceutical companies as they advance to commercial manufacturing and navigate complex processes.

9. Quality by Design (QbD) for Adeno-Associated Virus (AAV) 10/14/2021

   CMC is but one obstacle to gene therapy regulatory approval. Here we review a framework for QbD assessment of AAV products within the Chemistry Manufacturing and Controls documentation.

10. Controlling Trace Impurities In Chemically Defined Media 4/10/2023

    Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.