EDITOR'S DESK

  • Sterile Injectable Outsourcing Trends — What Biosimilar Developers Need To Know
    Sterile Injectable Outsourcing Trends — What Biosimilar Developers Need To Know

    Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

Solving Pharma’s Public Opinion Crisis

Americans' view of the pharma industry is at an all-time low. NSF Health Sciences Global VP Martin Lush says to change that, something radical will have to happen.

Why EU’s New Med Device Regs Matter To Biopharma

Pharma's CMC regulatory affairs staff, R&D leadership, manufacturing, quality and compliance professionals take note: the EU MDR is real, it becomes effective next May, and it brings with it new challenges and regulatory uncertainty for manufacturers of combination products.     

FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

Abcentra Chief Looks Beyond The Clinical Horizon

Why Bert Liang, M.D., Ph.D. obsesses over at-scale manufacturing and regulatory challenges from the outset of clinical trials. 

More From Our Editors

GUEST COLUMNISTS

  • 4 Tips For Successful Collaboration With Your EU Qualified Person (QP)
    4 Tips For Successful Collaboration With Your EU Qualified Person (QP)

    Qualified Persons (QPs) are responsible for the certification of clinical trial materials in the EU and therefore are an essential link in U.S. sponsors’ supply chains. Indeed, engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated technical, quality, and regulatory challenges.

  • Debunking The Top 3 Myths About Quality By Design (QbD)
    Debunking The Top 3 Myths About Quality By Design (QbD)

    Pharmaceutical quality by design (QbD) and quality risk management (QRM) principles have become mainstays in pharmaceutical development. However, several myths are prevalent that prevent wider acceptance of the concepts by smaller firms. The lack of understanding of pertinent quality by design methods prevents smaller firms from benefiting from the majority of what QbD offers.

  • New EMA Requirements On Nitrosamines: What ALL Pharma Needs To Know
    New EMA Requirements On Nitrosamines: What ALL Pharma Needs To Know

    The EMA recently issued two new publications containing information on nitrosamines for marketing authorization holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.

  • Will Authorized Biologics Disrupt The Market For Biosimilars?
    Will Authorized Biologics Disrupt The Market For Biosimilars?

    Many of the doomsday scenario predictions for biosimilar competition if authorized biologics were to enter the space prematurely assume mainstream development and adoption of authorized biologics by innovator companies in the current market and do not take into consideration the outcomes seen over the past 18 years with authorized small molecule generics.

  • Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project
    Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project

    Faced with competing priorities, teams often rush to turn their plans into projects while missing the important steps in between. Resource planning is chief among these oversights. 

  • Achieving Integrated Quality Through A Continued Process Verification Program
    Achieving Integrated Quality Through A Continued Process Verification Program

    Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement. 

  • Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework
    Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework

    The FDA's new pharmaceutical quality assessment system is intended to capture and manage information about inherent risk and control approaches for product design, manufacturing, and facilities, in a structured format with the intent to facilitate a concise and consistent quality assessment, and largely replace freestyle text.

  • The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial
    The EU Qualified Person (QP) Demystified: Fool-Proofing Your EU Phase 1 Trial

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.

More From Our Guest Columnists

BIOPROCESSING WHITE PAPERS

  • 5 ADC Manufacturing Challenges You Need To Know
    5 ADC Manufacturing Challenges You Need To Know

    Despite tremendous growth, drug makers still face a number of challenges in the manufacturing process for antibody-drug conjugates (ADCs). Here are key areas where pharma faces uphill battles.

  • A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

  • Avoiding Hemolysis Blood Sample Collection Processing

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

  • Scalable Production Of AAV Vectors

    This article examines some of the currently available schemes used in generating rAAV from suspension cultures, and describes what it takes to achieve scalable rAAV production.

  • Lyophilization Of Highly Potent Drugs: Facility and Equipment Design Elements

    Because scale-up and technology transfer of the lyophilization process is challenging, it is important to develop a comprehensive understanding of critical lyophilization characteristics early on.

  • Component Selection: The Key To Your Program Success

    Companies in need of aseptic syringe and vial fill and finish services may find themselves unprepared for selecting the right components and component supplier to meet the needs of their product. A critical process, which can be overlooked or underestimated, thereby jeopardizing clinical or commercial programs.

More Bioprocessing White Papers

BIOPROCESS ONLINE CONTENT COLLECTIONS

DataIntegrity

 

This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

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LIFE SCIENCE INDUSTRY EVENTS

Preparing eCTD Submissions: A Step-By-Step Guide November 19 - 19, 2019
1pm-2:30pm EST, Online Training
Establishing Appropriate Quality Metrics November 21 - 21, 2019
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Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
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TRAINING COURSES

Preparing eCTD Submissions: A Step-By-Step Guide November 19 - 19, 2019
1pm-2:30pm EST, Online Training
Establishing Appropriate Quality Metrics November 21 - 21, 2019
1pm-2:30pm EST, Online Training
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
More Upcoming Courses