Featured Articles

  1. Validation Accelerated 9/1/2021

    The challenge: A major pharma company’s need for scale-up and validation of a cGMP intermediate had been delayed for a while when the US FDA suddenly granted it priority status.

  2. Commercial Manufacturing In Half The Time 9/1/2021

    Due to FDA requirements for commercial manufacturing of regulated (GMP) intermediates, a global company needed a dedicated facility to produce its commercial antibiotic intermediate.

  3. The Biotech And The CDMO: The Case For An Early Partnership 10/2/2020

    Biotech investigators can’t possibly know everything required to move their drug candidate from the lab bench to the marketplace. Accepting that reality is the first step toward finding a strategic partner.

  4. It Hasn't Been Easy For Pharma To Be Green 10/2/2020

    Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.

  5. Breaking The Either-Or Paradigm Of CDMO Selection 8/13/2020

    Choosing a contract development and manufacturing organization (CDMO) often requires “either-or” tradeoffs that divide the candidate companies into polarities of size, location and services offered. 

  6. Rapid Change Is Everywhere In The Biotech Industry. Meaningful Innovation Is Not. 8/13/2020

    CDMOs face the challenge of integrating novel technologies to deliver cost-effective innovation to the market. How a CDMO responds to the unexpected can determine the success or failure of a project.