Formulation Development White Papers & Articles

  1. Industry Trends In Biologic Formulations

    In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.

  2. Overcoming Challenges Associated With Biologic Drug Formulation And Development

    Biologic manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Recently, the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges, including degradation. Read about the options provided by wearable technology offers new alternatives that were not previously possible due to historically binding parameters for formulators.

  3. Delivering Macromolecules: Challenges Associated With The Delivery Of Biologic Drugs

    Developers need to look beyond the formulation of a stable drug all the way to patient compliance. Numerous pitfalls exist along the journey to bring a biologic combination product to market. This integrated solutions program can help you simplify the journey.

  4. The Changing Landscape Of Wearable Drug Containment And Delivery

    As innovations in medicine enable the introduction of new therapies for the treatment of chronic conditions impacting patients around the globe, safely containing and delivering these therapies is top of mind for both pharmaceutical companies and their manufacturing partners. By partnering with a device or delivery system manufacturer early and often in the drug development journey, pharmaceutical manufacturers can not only move to market with an approved, commercially viable drug delivery system, but also gain valuable insight into the drug product along the way.

  5. Viral Clearance: 7 Chromatography Column Considerations

    Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.

  6. Benefits And Challenges Of Driving Modernization In Vaccine Development

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  7. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

  8. Developing A Scalable Process For Adenovirus Manufacturing

    To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  9. 6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  10. Critical Considerations About The Future Of Global Cell Culture Bioprocessing

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.