Outsourced Pharma App Notes & Case Studies

  1. How To Successfully Manage Your Suppliers And Ensure Product Safety And Compliance

    The more advanced manufacturing has become, the more streamlined it has gotten. Parts come from various suppliers throughout the world; certain functions or entire processes are outsourced.

  2. Elderly Representation In Clinical Trials: Not A Gray Area

    Typically, clinical trials conducted in adult populations include patients between the ages of 18 and 65. This is a broad range, but arguably no longer broad enough.

  3. The Role Of The C57BL/6N Mouse In The Creation Of Future Genetically Engineered Models

    Among animal species, the laboratory mouse has been instrumental in modeling human biology and disease states. The isolation of mouse embryonic stem (mES) cells in 1985 (Doetschman et al., 1985; Smithies, O. et al., 1985) and the subsequent ability to direct pre-planned mutagenesis of the murine genome by homologous recombination in the mES cells (Thomas et al., 1986; Kuehn et al., 1987), has allowed this seminal technology to address all aspects of mammalian biology. By Rosalba Sacca, PhD, Bruce Elder, PhD, and Katherine Wasson, DVM, PhD

  4. Management Of A Large And Complex Study In Rheumatoid Arthritis With EDC Solution

    This case study illustrates Chiltern’s in-house expertise in EDC and close collaboration with the study monitors ensured that this complex and large global project was concluded on time.

  5. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis

    Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how surface plasmon resonance has been applied for protein characterization of antibody effector function.

  6. Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  7. The Genes Of The Industry From BIO 2000 – 2014

    The first Biotechnology Industry Organization (BIO) annual conference and exhibition I attended was in 2000 in Boston. Early registrants had to be accompanied through cordoned walkways by Boston police mounted on large horses. There were crowds of people, some quite angry, waving creative signs and yelling about staying out of their genes and stopping the altering of their food.

    I am not one to be overly squeamish, but I remember thinking it was fifty-fifty: Either a protester would get me or I would be trampled by one of the horses. I was working in economic development for the state of New York as a Senior Director of Industry Development, and had just been handed the biotech industry cluster. Now I thought I knew why. Maybe I should have asked a few more questions.

  8. Continuous Flow Chemistry (Processing) for Intermediates and APIs

    Many contract manufacturing organizations (CMOs) offer continuous flow chemistry, but few have the technical capabilities to help customers take full advantage. The potential benefits for active pharmaceutical ingredient (API) development and manufacturing include higher selectivity, the ability to use novel chemistries, improved scalability, and enhanced safety.

  9. Risk Mitigation For Material Transport: The Impact Of Re-Using Shippers

    Ensuring your material is stored under appropriate conditions is only half the battle in preserving its integrity. Equally as critical is the precarious process of transporting your material to its destination, safely and in the same condition it was sent in. Maintaining the chain of custody is of utmost importance, and a large component of this is based on the vessel selected for transportation. In this article, we’ll share some key items to consider when selecting shippers to transport your high value material.

  10. Dissolved Oxygen Sensing: Considerations And Solutions

    In this technical note, Henry’s Law is reviewed, and various types of dissolved oxygen sensors are described and the performances evaluated and summarized.