INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Biologics Development, Manufacturing & Packaging Roundtable

  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.

• Selecting A CMO Partner For Sterile Injectable Manufacturing

  Performing the transfer of a product or technology from a small-scale development process to full-scale commercial manufacturing can be difficult, but vetting for the right CMO partner can pose its own challenges.

• Achieving Large-Scale Ophthalmic Production

  Ophthalmic treatments require a manufacturing partner with the expertise, quality assurance practices, and modern equipment necessary to ensure a safe, effective drug product.

• Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products

  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.

• Training Devices And Patient Education Play A Crucial Role In The Self-Injection Drug Delivery Market

  11/8/2021

  Understand the role training devices and patient education play with regard to self-injection therapies. Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

• A Quick, Cost-Effective Process For Large-Scale Compound Synthesis For A Leading Pharma Company

  11/5/2021

  The client was seeking a suitable route modification process that could demonstrate the scalability and safety of the final drug product at minimum cost. This case study explains how costs were minimized while ensuring quick turn-around time when scaling the compound from lab-scale to cGMP-scale.

• Selecting In Vitro Dissolution Methodologies For Amorphous Solid Dispersions

  10/25/2021

  With the availability of so many types of in vitro dissolution tests, how do you determine which one will be most effective in predicting in vivo performance of your BCS II or IV drug product?

• How To Reduce Change Orders In Your Product's Tech Transfer

  10/25/2021

  After conducting the legwork of determining the best fit for a CDMO from capabilities and organizational fit perspective, the next step is working with that vendor on determining costs.

• Continuous Flow Chemistry (Processing) For Intermediates And APIs

  10/15/2021

  Developing flow-based manufacturing processes requires expertise in several disciplines, the ability to design and build custom reactors, and the scientific infrastructure to support production.