• Guidelines To Bring Your Biologic To Market: Are You Prepared?
    Guidelines To Bring Your Biologic To Market: Are You Prepared?

    Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.

  • Reducing Cost within Advanced Therapy Clinical Trials
    Reducing Cost within Advanced Therapy Clinical Trials

    The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study, we’ll demonstrate how a company saw 55% cost savings across its distribution system, and increased visibility of its supply chain through meaningful data through partnering with Fisher BioServices and Fisher Clinical Services.

  • Controlling Complexity (Not Cost) Of Advanced Therapy Supply Chains
    Controlling Complexity (Not Cost) Of Advanced Therapy Supply Chains

    Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex.  Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost.  However, the biggest cost within the supply chain is caused by its complexity.  In this article, we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.

  • Development Of Qualified Cold Chain Solution For Vaccine Transport To Uganda
    Development Of Qualified Cold Chain Solution For Vaccine Transport To Uganda

    Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.

  •   Modular Bioprocessing Alleviates Drug Manufacturing Woes
    Modular Bioprocessing Alleviates Drug Manufacturing Woes

    Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries. BeiGene, a commercial-stage biotechnology company, can attest to these challenges.

  • ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes
    ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.

  • Developing A Scalable Process For Adenovirus Manufacturing
    Developing A Scalable Process For Adenovirus Manufacturing

    To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.

  • 6 Regulatory Changes Affecting Bioprocessing In China
    6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  • A Common Sense Approach To Sustainability In The Biosimilar Business
    A Common Sense Approach To Sustainability In The Biosimilar Business

    Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

  • Critical Considerations About The Future Of Global Cell Culture Bioprocessing
    Critical Considerations About The Future Of Global Cell Culture Bioprocessing

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

FEATURED PRODUCTS AND SERVICES

More Shots On Goal Using A Developability Assessment Tool More Shots On Goal Using A Developability Assessment Tool

Data-driven risk assessment enables smart decisions on development strategy.

Single-Use, Flexible Stirred-Tank Bioreactor System: Xcellerex XDR-10 Single-Use, Flexible Stirred-Tank Bioreactor System: Xcellerex XDR-10

This XDR single-use bioreactor is sized for the benchtop, yet allows smooth scale-up to full production.

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.

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.

ZipDose® Technology ZipDose® Technology

Developed with Aprecia’s proprietary 3DP manufacturing process, ZipDose® Technology helps patients who need medicines that are easy to take and caregivers—including physicians and nurse practitioners—who want medicines that are easy to administer. By enabling delivery of high-dose medications in a rapidly disintegrating form, ZipDose overcomes patient adherence and difficulty swallowing challenges.

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.

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INDUSTRY EVENTS

Stability Programs – Key Factors in Meeting FDA/ICH Expectations April 22 - 22, 2019
1pm-2:30pm EDT, Online Training
Instructional Design for GMP Training – Improve Effectiveness and Measurability April 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control April 25 - 25, 2019
1pm-2:30pm EDT, Online Training
Preparing eCTD Submissions: A Step-By-Step Guide April 29 - 29, 2019
1pm-2:30pm EST, Online Training
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 UPCOMING TRAINING COURSES

Stability Programs – Key Factors in Meeting FDA/ICH Expectations April 22 - 22, 2019
1pm-2:30pm EDT, Online Training
Instructional Design for GMP Training – Improve Effectiveness and Measurability April 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control April 25 - 25, 2019
1pm-2:30pm EDT, Online Training
Preparing eCTD Submissions: A Step-By-Step Guide April 29 - 29, 2019
1pm-2:30pm EST, Online Training
More Upcoming Courses