Outsourced Pharma App Notes & Case Studies

  1. Full IND Program: Exceeding Requirements For Submission 1/20/2022

    Follow a compound through a full cycle of IND development, from modifications to the synthetic route to formulation development and API manufacturing.

  2. Scale From Cell Factory Systems To A Bioreactor Without Affecting CQAs 12/20/2021

    The challenge was to identify an effective, replicable, and large-scale LVV manufacturing process to meet the growing manufacturing demand without affecting critical quality attributes.

  3. How To Optimize A Clinical Scale Manufacturing Process For Commercial Production 5/10/2021

    Given the large, global population of people affected by rheumatoid arthritis and the original mechanism of action of olokizumab, R-Pharm expects significant demand for the drug. The initial process used to manufacture drug substance for clinical trials was established nearly eight years ago. In this case study, you will discover more about how the R-Pharm Group collaborated with MilliporeSigma’s BioReliance® End-to-End Solutions to manufacture olokizumab for commercial production.

  4. How To Perform HPLC Method Transfer Between Analytical Testing Equipment 6/27/2022

    It is essential for the analytical laboratories to successfully transfer analytical methods. We present a transfer of the HPLC method for related substances analysis of metoclopramide HCl.

  5. Single-Use Technology For The Most Extreme Processes 6/7/2021

    Downstream processing for biologic drugs often requires the use of harsh chemicals that can damage SUT components. CPC designers identified a polymer to handle rough downstream chemicals.

  6. Fundamentals Of Size Exclusion Chromatography 5/20/2021

    SEC, also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?

  7. Expanding Project Leadership Through PMP Certification 12/20/2021

    PMP certification leads to both individual and organizational benefits, and it tells employers and clients a person is thoroughly trained to manage the entire project life cycle effectively.

  8. Challenges For Microbiome-Based Drug Development 2/23/2022

    The microbes residing in our gastrointestinal tracts, or the “gut microbiome,” are essential contributors to metabolism and may hold promise of new treatments for a range of therapeutic applications.

  9. Building An Army: Cell Therapy Platforms With Dr. Helen Sabzevari, CEO Of Precigen 8/18/2021

    Two of the biggest challenges facing the cell and gene therapy space today — controlling costs and optimizing scalability — have the potential to be addressed by companies through innovative, integrated technology solutions. In a recent episode of The Business of Biotech, Dr. Helen Sabzevari discussed how her company Precigen has used customized therapeutic and platform technologies to tackle scale-up in the CAR-T therapeutics space.

  10. Benefits Of RABS, Isolator Tech In A Changing Regulatory Landscape 8/10/2021

    Restricted access barrier system or isolator technologies are an integral component of quality control. Understanding the key elements of each ensures the most informed decision for your product.