Insights On CONTRACT PHARMA MANUFACTURING

  1. Approach To Simplifying Aseptic Contract Manufacturing
    9/9/2019

    Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug product. This article is the first in a series that describes some of the challenges and solutions available to pharmaceutical/biotech companies and their supply chain partners in the CDMO realm to ensure that critical clinical supply materials are ready when they are needed and how one CDMO, Singota Solutions, has positioned itself to meet these challenges.

  2. Managing Risks With Potent Pharmaceutical Products
    7/2/2019

    Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

  3. "Validation" Or "Qualification" – What’s The Difference?
    6/25/2019

    What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

  4. The Criticality Of API CDMO Selection: Insights From A Client
    6/17/2019

    4SC AG, a clinical-stage biopharmaceutical company partnered with Thermo Fisher Scientific Pharma Services, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.

  5. Manage Risks In Development And Manufacture Of Potent Pharma Products
    6/17/2019

    Given the variety of potent drugs in development, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multi-use facility, is an effective strategy.

  6. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
    6/10/2019

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  7. Scale Matters: A Flexible Approach To Demand Uncertainty
    6/5/2019

    Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.

  8. The Importance Of Data Analysis In Solid-State Characterization
    5/28/2019

    The secret to performing a thorough solid-state characterization involves integrating all data that may be generated across various instruments at different laboratories and properly interpreting that data.

  9. Selectivity In Size Exclusion Chromatography (SEC): It’s Much More Than Average Pore Diameter (Å)
    5/22/2019

    Describing the pore of a size exclusion chromatography resin with a single number such as average pore diameter is an oversimplification. The formation of pores is dependent on complex combinations of many parameters.

  10. Your Strategy To Manufacture, No Longer A One-Size-Fits-All
    5/14/2019

    The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.