Industry Insights

  1. Anticipating The Formulation Challenges Of Complex Molecules

    If formulation problems surface late in the process of turning active pharmaceutical ingredients (APIs) into beneficial drug products, developers may have to go back and change their API production processes. In the worst cases, Phase 1 and Phase 2 trials may have to be redone. And due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.

  2. Selecting The Optimal Resins For IgG Process Purification

    Immunoglobulins (Ig), or antibodies (Ab), are the heavy globular plasma proteins produced in response to foreign bodies or antigens. They exist in five isoforms: IgA, IgD, IgE, IgG, and IgM. IgG provides the majority of antibody-based immunity. By Payal Khandelwal, PhD

  3. How Global Pharma Orgs Can Achieve Process Validation Success

    The pharmaceutical market has transformed into a global industry within the span of just a few decades. Many companies have sites across the globe, presenting challenges when it comes to harmonizing process validation approaches among sites. There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary to achieve success.

  4. From Discovery To Development: GS Expression System For Next-Generation Biologics

    Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years, next-generation biologics have complex designs. If you are first in class or you have a very bespoke up- and downstream process, it also means you will have bigger hurdles to overcome when it comes to regulatory support and filing. At Lonza, these challenges are addressed with the GS™ expression platform.

  5. The Evolution Of Temperature Control

    A visual history of cold chain innovation.

  6. Balancing Technologically Advanced Products and Thrifty Healthcare Consumers

    Developers of diagnostics devices are faced with the ever-increasing challenge of balancing the drive to create technologically advanced products with the pressures of today’s thrifty healthcare consumers. During the innovation process, the question often arises as to what level of regulation a diagnostic product needs to be designed, manufactured, and tested to. This article provides a brief overview of the requirements and considerations for the clinical diagnostic innovations.

  7. How To Boost Profits With Single-Use Powder Transfer In Biopharma

    Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?

  8. Challenges & Opportunities In The U.K. Biosimilar Market

    Despite having a generics market which fulfils nearly three-quarters of all prescriptions in the U.K., delivering some of the lowest medicines prices in Europe as a result, there still remains a surprising degree of mystery surrounding biological and biosimilar treatments.

  9. Japan’s Expanding Role In Pharma

    Japan is the world’s second-largest single-country pharmaceutical market, accounting for approximately 10 per cent of global drug sales and expanding quickly.

  10. Improving Single-Use Film To Achieve Optimal Performance In Biomanufacturing

    The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.