Cambrex Industry Insights

  1. "Ultra High" Potency Development And Manufacture 1/20/2022

    A biotech with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

  2. Speed To Market – API Large-Scale Commercial Manufacturing 1/20/2022

    Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

  3. Adapting To Change – API Custom Development And Manufacturing 1/20/2022

    A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase II / III trials.

  4. Investing In Capacity – API Commercial Manufacturing 1/20/2022

    A pharma company sought a CMO partner with commercial manufacturing capabilities and expertise as well as exemplary quality systems to find a cost-effective process to produce the API for a new drug.

  5. Outsourced Drug Development: Short-Term Solution Or Long-Term Strategy?

    As we look forward to the future of drug development, a panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

  6. Approaching IND: What To Consider In Early Development

    When preparing for IND submission, developers must consider multiple components. Explore tips for optimizing your early development program and the benefits of housing all activities under one roof.

  7. End-To-End Development And Manufacturing: Small Volume Commercial Products

    To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

  8. Design Of Experiments Approach To Enabling Studies For Process Validation

    A recent project applied process improvement methodology to the process validation step that ultimately provided not only an optimized, robust process but also an economic advantage.

  9. Post-Pandemic Outsourcing Demand: How Are CDMOs Responding?

    Ultimately, to serve the highly competitive biopharma and pharmaceutical markets, CDMOs must be adaptable to the culture of the company for whom they are working.

  10. Two Steps Forward, One Step Back: IND Submission In Early Development

    A panel of product development experts examines blind spots that can plague early development strategies, as well as important considerations when navigating the path toward an IND submission.