Ebook

    Pharma Supply Chain Risk Management

    Pharma Supply Chain Risk Management

    09.09.21 - 09.09.23

    2020: A Year Unlike Any Other
    What we learned and how to be prepared for the next big interruption.
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    The Supply Chain House of Cards
    The COVID-19 pandemic exposed pressures on extended global supply chains.
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    The Role of Secondary Suppliers in Biopharma Supply Chain Strategy
    The growing importance of secondary sourcing in the biopharma industry.
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    Pharma Supply Chain Trends
    Overcoming the challenges of today’s global pharma supply chain.
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    Supply Chain Risk Mitigation
    Addressing the inherent risks in an increasingly fragmented supply chain.
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    Analytical Method Transfer Best Practices
    To ensure successful Analytical Method Transfers it is critical to develop a well-defined transfer plan with open lines of communication.
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    Pharmaceutical Outsourcing for Oral Development and Manufacturing

    Pharmaceutical Outsourcing for Oral Development and Manufacturing

    08.12.21 - 08.12.23

    Oral Solids Remain Robust
    Exploring trends in the oral solid dosage manufacturing market with some of today’s leading contract service providers.
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    Recent Advances in Solid Dispersion Technologies
    Delivering Improving the bioavailability and therapeutic efficiency of poorly soluble drugs.
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    Drug Product Development
    A few key drug development considerations and deliverables from an early or late phase drug development perspective.
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    Pediatric Oral Drug Delivery: Challenges and Solutions
    Delivering medicines in the right doses for pediatric patients creates unique challenges for the pharmaceutical industry.
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    Solid Dosage Manufacturing
    Solving common problems in solid dose manufacturing
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    Clinical Trial Supply Services

    Clinical Trial Supply Services

    July 19 - 31, 2024

    Clinical Trial Supplies Planning and Management
    There are a significant number of factors that affect the complexity of planning and managing clinical supplies.
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    Optimizing Clinical Supply Management
    IRT system design strategies to help life science companies cut drug wastage across clinical programs.
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    Cold Chain Trends
    There is a growing need for convenience through Direct-to-Patient and Direct-from-Patient services in clinical trials.
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    COVID-19: Keeping Clinical Trials Moving
    How DTP and virtual services keep clinical trials moving during pandemic and beyond.
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    Cell & Gene Therapy Outsourcing Trends

    Cell & Gene Therapy Outsourcing Trends

    July 14 - 31, 2023

    The New Wave of Innovation
    Cell and gene therapies represent the new wave of innovation in the life sciences industry.
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    Allogeneic T-Cell Therapies
    Efficient commercial manufacturing readiness using “Manufacturing by Design” methodology.
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    New Supply Chain Considerations in Response to Covid-19
    Cell & gene therapy companies have faced unique challenges due to the nature of their therapies, this is especially true for autologous cell therapies.
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    The Future is...Therapeutic
    As cell and gene therapies rise, so too does outsourcing.
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    HPAPI Development and Manufacturing Trends

    HPAPI Development and Manufacturing Trends

    05.20.21 - 05.20.22

    HPAPI Market Trends
    Rising demand for targeted cancer and other treatments driving HPAPI growth
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    HPAPI Technology Trends
    Expanding HPAPI sector driving innovation in containment technology.
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    High Potency APIs: Some Bad News, Some Good News
    The growing use of HPAPIs has created some challenges in the lab, while at the same time offering advantages as well.
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    Antibody-Drug Conjugates: Catalysts for Chemistry
    (ADCs), also known as armed antibodies, are highly anticipated to be the source of next generation frontline oncolytic therapy.
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    Pre-filled Syringes & Injectable Drug Trends

    Pre-filled Syringes & Injectable Drug Trends

    11.23.20 - 11.23.21

    Pre-sterilized Packaging
    From pre-filled syringes to combi-filling, the latest trends in processing pre-sterilized primary packaging.
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    Pre-filled Syringes: Contributing to Better Patient Outcomes
    Five ways pre-filled syringes are improving patient outcomes as much as the medicines they deliver
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    Partnering for Patients
    Combining the power of innovative drugs and their delivery systems.
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    Biopharma Contract Fill-and-finish Market Trends
    Biopharmaceuticals continue to fuel growth in the pharmaceutical industry.
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    A Changing Healthcare Landscape
    Navigating the road ahead with a focus towards patient centricity.
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    Next-gen Contract Packaging Trends
    Insight into the latest pharma and biopharma trends, packaging innovations, challenges and opportunities.
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    The Future of Pharmaceutical Manufacturing

    The Future of Pharmaceutical Manufacturing

    07.31.20 - 07.31.21

    The Future of Pharmaceutical Manufacturing
    Discussing the need for a digital revolution to drive pharma manufacturing innovation.
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    Making the Cloud to Modern Cloud Solutions
    Veeva’s Michael Jovanis weighs in on the challenges and benefits of going digital in the pharma space.
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    Quality Management: Preserving and Perpetuating your Record
    CDMOs must ensure that their top priority be delivering the highest quality products.
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    Data Management in Life Sciences: Then and Now
    A look at landmark changes in the management of data in the life sciences over the last 20 years and how the industry has addressed the challenges these developments have posed.
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    Elevating Process Engineering to Improve Predictability, Reliability & Productivity
    It is past time for drug makers to shift from a document- and compliance-centered paradigm to one focused on science and engineering.
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    Comprehensive Analytical Services:

    Comprehensive Analytical Services:

    07.01.19 - 07.01.20

    Elemental Impurities: Getting from Risk Assessment to Regulatory Submission
    Taking the next steps from risk assessment through method development, method validation and testing to the updating of an annual report or including elemental impurity data in a new regulatory submission.
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    Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
    Understanding and developing strategies for risk assessment and analytical testing to ensure compliance with the requirements of ICH Q3D, Guideline for Elemental Impurities, USP <232>, “Elemental Impurities, Limits,” and USP <233>, “Elemental Impurities, Procedures.”
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    Elemental Impurity Testing
    Advances in elemental impurity testing aid compliance with new USP requirements
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    ELEMENTAL IMPURITIES: A VIRTUAL COMPANY PERSPECTIVE
    A look at risk assessments for elemental impurity determinations in oral tablet and parenteral drug products. Read More >>
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    Biopharmaceuticals & Analytical Testing Technology

    Biopharmaceuticals & Analytical Testing Technology

    06.01.19 - 06.01.20

    Current Trends in Analytical Testing
    Improved analytical methods continues to be a current need for nearly every aspect of biopharma manufacturing
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    Are We Embracing FDA’s Messages?
    FDA guidance on analytical procedures and methods validation for drugs and biologics.
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    Next-Gen Bioprocessing
    Overcoming the challenges of characterizing bioprocess residual impurities in biologics using HPLC/MS
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    Process Validation in Biologics Development
    Strategies for successful process validation in the wake of faster approval timelines Read More >>
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    Trends in Biologics Manufacturing from Drug Substance to Fill/Finish

    Trends in Biologics Manufacturing from Drug Substance to Fill/Finish

    November 1 - 30, 2019

    Biopharmaceutical companies and contract manufacturing organizations are investing to increase biomanufacturing and drug product fill-finish capacity in order to keep up with the pace. Fast track approvals, increased focus on orphan diseases and the emergence of personalized medicine are influencing how the industry makes its investment decisions. This ebook examines current and future trends in biologics development and manufacturing and the steps companies are taking to address this changing landscape.

    Biopharma Manufacturing Markets
    Biomanufacturing contract services and supplies markets continue to expand.
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    CEO Spotlight — Catalent
    A conversation with John Chiminski, CEO of Catalent Pharma Solutions.
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    Biopharmaceutical Contract Manufacturing Trends
    Examining the importance of fill-and-finish operations in today's biopharma manufacturing market.
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    Next-Gen Biologics Packaging & Delivery
    As the frontier of drug innovation evolves, so must the design of packaging and delivery systems. Read More >>
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