Industry Insights

  1. Make The Right Container Choice For Critical Environments
    8/22/2017

    There are a number of factors to be taken into consideration when selecting containers for use within a critical environment.

  2. New Tufts Study Uncovers The Economic Advantage Of Single-Source Drug Development And Manufacturing
    10/18/2017

    With patient care at the forefront, it is critical to assess the economics of both outsourcing models and ensure the one you select provides the most efficient path to commercialization. This was the purpose of a recent study by the Tufts Center for the Study of Drug Development (CSDD), which compared cycle times and development economics between multi- and single-source CDMO models.

  3. Modular Approaches For Diverse Molecules: Reinventing Smart Bioprocessing
    2/23/2018

    Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.

  4. Incorporate Data Integrity Into Your Pharma Quality Management System
    3/28/2017

    A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable. 

  5. Is Selecting A CDMO Based On Contract Price Really Saving You Money?
    11/16/2017

    Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

  6. What You Need To Know To Avoid Costly Delays In Your API Scale-Up
    8/22/2017

    If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. 

  7. Virtue Is Harmony: Using Lab Data Automation To Break Down The Silos In Pharma R&D
    6/7/2017

    In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.

  8. Characterize Drug Substance Properties Early To Optimize Drug Formulation
    8/13/2017

    Drug substance characterization is critical to drug product formulation but characterization and formulation are often not integrated during drug development. 

  9. Powerful Tools For Downstream Process Development: Mixed-Mode Resins/Multimodal Chromatography
    8/21/2017

    With their unique separation behaviors and tolerance for relatively high salt concentrations, mixed-mode resins have become important tools in the process developer’s toolbox.

  10. Phase II And Phase III Studies Standard Protocol A Template For Success?
    5/25/2017

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.