1. Integrating Safety And Immunogenicity Assessments Into The Biopharma Preclinical Development Process

    Efficacy, safety, immunogenicity and manufacturability issues play a large role in the high attrition rate of biopharmaceutical candidates each year. To help reduce the risk of failure, tools to address the developability of preclinical candidates have been established.

  2. Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market

    With the U.S opioid analgesic addiction and overdose crisis showing no signs of relenting, change is coming fast for manufacturers of chronic pain drugs.

  3. Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century

    This article will be part of the CPhI 2016 Annual Report, which will be released during the CPhI Worldwide event in Barcelona (October 4-6, 2016).

  4. 5 Steps To Build A Quality Culture That Supports Data Integrity

    When it comes to building a culture of quality, many companies ask, "Where do we start?”

  5. How Health Systems Will Manage Biosimilars: Implications For Manufacturers

    The FDA recently approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), for multiple indications, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease. Despite being studied in clinical trials only for rheumatoid arthritis and ankylosing spondylitis, the FDA granted infliximab-dyyb nearly all of Remicade’s indications based on the infliximab-dyyb clinical package. The FDA stopped short of determining the biosimilar to be “interchangeable,” as standards for interchangeability have not yet been finalized.

  6. Scale-Up Of E. coli Fermentation From Small To Pilot Scale

    The scale-up of fermentation processes is critical to the success of industrial fermentation for the production of biologicals in the biopharmaceutical market. Eppendorf bioprocess systems are available with autoclavable, single-use and sterilize-in-place vessels and together cover a wide range of working volumes from less than 1 L to as large as 2,400 L.

  7. FDA vs. EMA? A Review Of Recent EU Enforcement Actions In The U.S.

    The FDA and the European Union (EU) have taken serious enforcement actions against several firms in the other’s geographic jurisdiction during the calendar year 2016. Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours activity represents an unofficial test, of sorts, as these agencies move to rely more on each other’s inspections — though these recent actions may test the limits and validity of such mutual recognition.

  8. Biodevelopment Services: From Molecule To Commercial Production

    Are you looking to expand the production of your recombinant proteins, vaccines or plasma commercial drugs? Do you need to bring affordable biosimilars to emerging markets?

  9. Provantage® End-To-End Services Brochure

    Provantage® End-to-End Services encompass the support and expertise you need to accelerate clinical drug development, scale your process and implement local production facilities, globally.

  10. Intelligent Virus Defense: Centinel

    Viral Resistance For The Future.
    Centinel™ technology goes beyond viral insurance. It’s an integral component of a sophisticated virus mitigation strategy for preventing, detecting and removing viruses.