• The Criticality Of API CDMO Selection: Insights From A Client
    The Criticality Of API CDMO Selection: Insights From A Client

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

  • Top Considerations To Meet FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies
    Top Considerations To Meet FDA Requirements For Packaging Cryogenically Frozen Advanced Therapies

    US Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.

  • Managing Risks To Time Critical Product Imports At Clinical Supply Depots
    Managing Risks To Time Critical Product Imports At Clinical Supply Depots

    A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. With the protocol based in the US and the investigational medicinal product (IMP) approved in the EU, the customer incorrectly assumed and, without checking further requirements, that Israel had the same QP (qualified person) approval process as the EU. This case study outlines the steps that Catalent took to ensure the QP release process could quickly advance in Israel while simultaneously updating the warning labels to meet the QP requirements.

  • Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
    Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  • Innovative Clinical Supply Solutions - Cold Chain
    Innovative Clinical Supply Solutions - Cold Chain

    With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.

  • Benefits And Challenges Of Driving Modernization In Vaccine Development
    Benefits And Challenges Of Driving Modernization In Vaccine Development

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

  • A Strategy To Remove Formulation Development From The Critical Path During Biologics Development
    A Strategy To Remove Formulation Development From The Critical Path During Biologics Development

    Biopharmaceuticals tend to be highly unstable. A pilot formulation study at the early drug substance development stage can make things considerably easier at the manufacturing stage, according to Yunsong (Frank) Li, director of process development at Catalent Biologics, in this Pharmaceutical Technology interview.

  • A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
    A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations

    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.

  • Comparing Continuous And Batch Processing in Downstream Purification
    Comparing Continuous And Batch Processing in Downstream Purification

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

  • Advanced Therapies: Reimbursement And The Impact Of Hidden Supply Chain Costs
    Advanced Therapies: Reimbursement And The Impact Of Hidden Supply Chain Costs

    While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated.  In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.

FEATURED PRODUCTS AND SERVICES

Comparator Sourcing Comparator Sourcing

The complexity of high cost biologics means comparator may be one of the highest line items in your clinical trial budget. Our Comparator Center of Excellence Team can consult and assist you in managing the full breadth of your comparator sourcing needs. Utilizing Fisher Clinical Services’ comparator sourcing services will provide you access to a global sourcing network and an overall de-risked supply chain. Currently 15 out of the top 20 worldwide pharmaceutical and biotechnology companies, as well many small pharmaceutical and biotech start-ups, actively utilize our comparator sourcing and strategy services.

Gibco BioProduction Services Gibco BioProduction Services

Gibco BioProduction Services can support and partner with you no matter what your comfort level is with intellectual property.  Our team of professionals will work with you to provide the best customized solution for your particular situation.  You will receive exceptional customer service from start to finish.

Biologics / Large Molecule Analytical Services Biologics / Large Molecule Analytical Services

Leading Analytical Scientists with Advanced Instrumentation.

An Overview of BIOVIA Environmental Health and Safety Solutions An Overview of BIOVIA Environmental Health and Safety Solutions

Organizations need to manage chemicals safely from receipt to disposal along the entire lab-to-plant value chain, ensuring Environmental Health and Safety (EH&S) compliance across the enterprise.

ZE5™ Cell Analyzer ZE5™ Cell Analyzer

The ZE5 Cell Analyzer is an innovative new flow cytometer with flexible configurations to meet a broad range of experimental complexities and throughput needs. Whether it’s a low-complexity, or a high-complexity experiment, the ZE5 Analyzer has up to 30 parameters and provides a truly expandable flow cytometer. This flexibility makes the ZE5 Analyzer accessible for novice flow cytometry users yet flexible enough for the most experienced flow cytometry professionals

Arcos™ Block Management System Arcos™ Block Management System

Minimize errors, increase productivity and keep your laboratory’s resources focused on what matters most—positive patient outcomes—with the Thermo Scientific™ Arcos™ Block Management System.

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 UPCOMING TRAINING COURSES

Reacting to “Human Error” – Moving Beyond “Retraining” As A Response June 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Mock Regulatory Inspections: How to Get the Most Bang for Your Buck July 11 - 11, 2019
1pm-2:30pm EST, Online Training
Cleanroom Microbiology – A Foundational Introduction July 18 - 18, 2019
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