Outsourced Pharma App Notes & Case Studies

1. Scheduling Aseptic Filling For Preclinical And Clinical Batches 9/23/2021

   Flexible production scheduling from a CDMO helps sponsors control costs and timelines even when unexpected development delays occur.

2. Spray-Dried Dispersions Enable Local Delivery For Lung Cancer 4/20/2021

   Learning more about spray drying as well as two case studies detailing its success serve as a critical tool in developing innovative and effective lung cancer therapies.

3. Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products 11/8/2021

   IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.

4. CAR-T Cell Lentiviral Transduction By Spinoculation 5/21/2020

   There is a growing need to close and automate manufacturing of chimeric antigen receptor (CAR)-T cell therapies. Learn how to streamline this step while keeping flexibility during process development.

5. Achieving Shorter Production Time For A Pancreatic Cancer Drug 1/20/2022

   Panbela was producing its small molecule candidate SBP-101 using a 15-synthetic step literature preparation. Syngene recommended a chiral purity check of early batches to ensure compliance with FDA guidelines.

6. Real World Evidence Saves Project 8/27/2021

   Read the available case study to figure out the solution to how a biotech company could not afford the time and expense to conduct studies recommended by its consultant and agreed on by the FDA.

7. The Many Benefits Of Outsourcing Stability 10/14/2021

   In the typical scenario of a drug discovery, development cycle and manufacturing, stability studies play a crucial role in validating the sustainability of the drug substance or the drug product when exposed to varied temperatures and storage conditions.

8. Patient-Centric Dosage Forms: A Viable Solution To Non-Adherence 11/5/2021

   Better adherence can often result by considering therapy- and patient-related factors during the design and development of patient-centric dosage forms.

9. Overcome Common Pre-Filled Syringe Challenges Through Partnership 11/29/2021

   The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.

10. Biologics Development, Manufacturing & Packaging Roundtable 11/16/2021

    A panel of experts discussed challenges and opportunities related to the development, clinical phases, and commercialization of biologics. They also offered insights on how to improve sponsor-CDMO relationships.