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FEATURED ARTICLES

  • Solving the OOS Problem with Continuous Manufacturing
    Solving the OOS Problem with Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec. And when it isn’t, as will sometimes (albeit rarely) happen, the manufacturer can step in more quickly than ever before to limit the volume of OOS product — saving time, money, and staying ever closer to the ideal quality standard.

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WHITE PAPERS & CASE STUDIES

  • Manufacturing Process Scale-up For Phase III
    Manufacturing Process Scale-up For Phase III

    Is your team ready to manufacture larger batch sizes to support if Phase III studies are on the horizon?

  • A Case Study In Real-Time Release Testing
    A Case Study In Real-Time Release Testing

    Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.

  • Implementing PAT And Qbd Real-Time Particle Size Measurement For The Pharmaceutical Industry

    As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments

  • Pharmaceutical Manufacturing: The Challenge Of Setting Effective Product Specifications

    Setting meaningful and realistic specifications is an essential element of Quality by Design (QbD). Well-defined specifications control product performance since they derive from correlations between clinical behaviour and the variables measured routinely during processing and for QC. This paper examines the process of setting specifications, taking as an example particle size, a critically important parameter for many pharmaceutical formulations. By Malvern Instruments

  • Quality By Design In Biomanufacturing

    QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

  • Accelerating Generic Approvals: 5 Keys To Being First To Market

    Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.

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PRODUCTS & SERVICES

R&D Freeze Dryer R&D Freeze Dryer

The LyoCapsule Freeze Dryer is a lyophilization instrument that delivers results comparable to larger R&D freeze dryers enabling a Quality by Design (QbD) approach to cycle development even when materials are highly expensive or limited in quantity.

Pharmaceutical Formulation And Development Services Pharmaceutical Formulation And Development Services
Kemwell’s Pharmaceutical Development Unit (PDU), in India and Sweden are led by a strong management team with the necessary experience, scientific knowledge, vision and steadfast commitment to meet each customers’ needs.
CMC Workshop: Translating Science Into Successful Regulatory Submissions CMC Workshop: Translating Science Into Successful Regulatory Submissions
Discuss Challenging Topics Facing the Pharmaceutical and Biopharmaceutical Communities from Development, Implementation, and Regulatory Submissions Perspectives.
Extractables / Leachables Studies Extractables / Leachables Studies

Extractable and Leachable studies are often straightforward, but they also can be some of the most analytically challenging components of a development program.

<I>Calculations Through Operations&reg;</i> Calculations Through Operations®

Multisorb Technologies provides leadership, innovation, and solutions utilizing active packaging components to manage moisture, oxygen and/or hydrocarbons in healthcare product packaging to improve product stability.

Powder Flow Tester Powder Flow Tester

AMETEK Brookfield's Powder Flow Tester delivers quick and easy analysis of powder flow behavior in industrial processing equipment. The PFT is ideal for manufacturers who process powders daily and want to minimize or eliminate the downtime and expense that occur when hoppers/silos fail to discharge.

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