White Papers

  1. In-Situ, Non-Destructive Surface Area Measurement For The Optimal Application Of Lyophilization

    Lyophilization, or freeze drying, is a vital process for the pharmaceutical industry. Around 35% of biologic drugs are currently lyophilized and this figure is projected to increase significantly in coming years. In this whitepaper we examine one of the Critical Quality Attributes (CQA) of lyophilized products – the surface area of the cake. A key focus of this paper is the relevant measurement of surface area, with experimental data demonstrating the performance and value of novel instrumentation for in-situ characterization.

  2. Scaling A mAb Production Process To A Single-Use Platform

    The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.

  3. Application Enhancements For The HyPerforma S.U.B.

    With many end users now demanding streamlined operations, high-density culture in fed-batch modes, even higher production by perfusion cultures, and contrastingly gentle operations required in microcarrier applications, standard S.U.B. offerings must keep pace with the ever-evolving needs of the bioprocessing industry. Read about recent enhancements that are helping keep up with these increasing demands.

  4. Top 3 Development Principles For Advanced Biopharmaceutical Tubing: Part 1

    Tubing is arguably one of the earliest components in the pharmaceutical industry to be associated with single-use technology (SUT). Every component used in biopharmaceutical processing — large or small — is pivotal to the ultimate goal of delivering safe and effective medication. To deliver cleaner materials and actively mitigate risk in biopharmaceutical manufacturing, evaluation of single-use tubing based on the following development principles should take place.

  5. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics

    Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  6. Optimize Sourcing And Standardization Of Cross-Program Parts

    The costly proliferation of parts and components that often accompanies the pressure for product differentiation and customization can be controlled through multiple strategies. One of the easiest and most effective of these is to deploy EXALEAD Sourcing & Standardization Intelligence. By combining information sources with semantic information, these new products and applications go beyond the limits of conventional analytics solutions and deliver simple user experiences for decision makers.

  7. Preventing Sticking And Picking Through Tablet Design

    Sticking or picking issues are often not detected until transferring the product from research and development to production. Prevent unanticipated problems during scale up and full-scale production by considering tablet compression issues before tablet designs are finalized.

  8. Under Pressure: Breaking The Misconceptions Of Maximum Compression Force

    It is common for tablet manufacturers to exceed the maximum compression force ratings of their tooling to form a quality tablet. However, going beyond the prescribed tooling rating may result in premature tool wear or failure and possible damage to the press. With proper formulation development and tablet design, the tablet press operator should be able to manufacture quality tablets without exceeding the tooling’s maximum compression force rating.

  9. Data Gathering And Analysis Necessary In New Tablet Development

    A significant concern in tablet manufacturing is speed to market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of Quality by Design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.

  10. Relying On Third Party Organizations For Strategic Equipment Acquisitions

    One of the most critical decisions for a pharmaceutical company is the choice to outsource operations, which leads to determining the optimal supplier with which to partner. When choosing an organization, a company must prioritize risk minimization and choose a dependable supplier with a strong track record. A facility is only as strong as the equipment that it runs, and production is only as effective as the equipment operators.