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  • Managing QbD From A CMO Perspective
    Managing QbD From A CMO Perspective

    The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.

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  • 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.

  • MTOSoftgels: Providing Cohort Specific Hand Filled Softgel Capsules For Dose Escalation Studies

    Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. By Lisa Z Crandall

  • White Paper: Advancing Regulatory Science For Public Health This document outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA, working with partners, to strengthen the field, both within the agency and throughout the Nation. By Food and Drug Administration (FDA)
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Manufacturing Process Development

Manufacturing Process Development

As early in your project as possible, Patheon's goal will be to solidify a process that sets you up for commercial success. A process that can be readily scaled up from small batch to commercial supply with minimal risk of costly delays and built to deliver repeatable quality.

Clinical Trial Material Manufacturing: Phase II & Phase III

Clinical Trial Material Manufacturing: Phase II & Phase III

Patheon offers expertise in GMP manufacturing of materials to support Phase II and III clinical trials, as well as product registration. 

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.
Data Analysis Consulting

Data Analysis Consulting

Our consulting services help you unlock value within your business and can quickly provide significant returns on your investment.
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 (PFT)

Powder Flow Tester (PFT)

Brookfield Engineering's Powder Flow Tester delivers quick and easy analysis of powder flow behavior in industrial processing equipment.

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