1. Pharma’s Vital Interest In Tracking State Biosimilar Substitution Laws

    State lawmakers continue to spearhead legislative boundaries to automatic biosimilar substitution at a rapid clip across the nation, with 33 states and Puerto Rico having taken action and with bills pending in eight more states. The U.S. Food and Drug Administration (FDA) oversees approval of biosimilar interchangeability designations and in January released its long-awaited draft guidance detailing the agency's expectations for demonstrating such interchangeability. However, achieving “interchangeable” status (i.e., demonstrating that a biosimilar may be substituted for its reference product under the FDA rules) will only be one step toward attaining product substitution, as overarching control is being assumed by state legislatures.

  2. An Introduction To Process Analytical Technology

    Our industry is engaged in the discovery, development, and production of high-quality, safe, and efficacious medicines intended for reducing the suffering and improving the lives of our patients. Ensuring medicinal product quality is our responsibility, and the FDA has written that “quality cannot be tested into products; it should be built in by design.” Many of our medicines are structurally complex or are made via complex processes (which include the use of hazardous materials). So, end-product testing alone is an insufficient measure of product quality, from our patients’ perspectives.

  3. The Basics Of Cleanroom Design & Material Transfer For Microbial Control

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects

  4. Using Risk-Based Thinking To Manage Suppliers

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concepts of risk management are not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.

  5. ILC An Ideal Technology To Achieve Inline Volume Reduction And Process Optimization

    Inline Concentrators have the capabilities to not only provide additional capital savings but also resolve potential manufacturing floor space limitations.

  6. Inline Concentrator Modules: Cleanability And Reusability

    Understand the study methods used to determine the integrity, process performance, and product retention of the Cadence Inline Concentrator (ILC) modules.

  7. Scalability Of Inline Concentrator Modules For Bovine IgG Processing

    Read how this extension of Pall’s SPTFF product line is designed to achieve concentration factors of 2 to 4X (or higher) and can be placed virtually anywhere within a given bioprocess to enable inline volume reduction and concentration.

  8. Simplify Processes And Lower Costs With New Single-Pass TFF Technology

    Understand how single-pass TFF technology brings practical and economic advances to TFF by simplifying the process and creating new capabilities including increased yield of product due to improved recovery capability and lower hold-up volume and Increased final product concentration due to high concentration factor capability.

  9. Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline

    Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. Many drug makers have been preparing for this so-called “serialization” deadline for years by implementing new processes and systems in their internal operations, or by ensuring efficient transfer of serialization data from their contract manufacturing/packaging partners. However, some manufacturers — in particular, smaller or virtual firms — are now engaged in a mad scramble to meet all the requirements of the deadline.

  10. Small Molecule API Brochure

    Ensure that you always have the exact resources and expertise you need, especially for your most difficult to manufacture compounds.