EDITOR'S DESK

Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must 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.

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GUEST COLUMNISTS

  • Sampling And Testing Of ATMPs: Gaining Insights From PIC/S Annex 2A
    Sampling And Testing Of ATMPs: Gaining Insights From PIC/S Annex 2A

    With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel like they are walking on a precarious limb.

  • Biosimilars: Lessons Learned From Regulatory Approvals
    Biosimilars: Lessons Learned From Regulatory Approvals

    The EU has approved 16 biological molecules, and the U.S. has licensed the same molecules (including approving some as 505(b)(2) approvals), except for follitropin alfa, which amounts to 114 biosimilars, combined. This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to assure faster approval of biosimilars.

  • Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers
    Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers

    The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching.

  • Improve Packaging Line Efficiency Through Overall Equipment Effectiveness
    Improve Packaging Line Efficiency Through Overall Equipment Effectiveness

    This article focuses on efficiency initiatives, providing some insights on how to better use overall equipment effectiveness (OEE) tracking systems and how to avoid common mistakes.

  • Can The FDA Salvage Interchangeable Follow-On Biologics?
    Can The FDA Salvage Interchangeable Follow-On Biologics?

    Learn the statutory and regulatory requirements for interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.

  • Process Characterization: The Foundation For Validation
    Process Characterization: The Foundation For Validation

    Process characterization is the foundation for process validation activities. Too often, validation activities fail due to the lack of process characterization using sound statistical and scientific methods, including design of experiments (DOE).

  • People: The Most Persistent Risk To Data Integrity
    People: The Most Persistent Risk To Data Integrity

    HR changes continually impact overall data integrity—from a single new hire to a corporate-level change with a merger or acquisition. It's a commonly overlooked weak link in the data integrity chain.

  • Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)
    Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them)

    There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.

More From Our Guest Columnists

BIOPROCESSING WHITE PAPERS

  • Critical Factors Of Fill Finish Manufacturing For Large Molecules
    Critical Factors Of Fill Finish Manufacturing For Large Molecules

    Compared to small molecules, large molecules generally require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, which is forcing changes at nearly every level of the manufacturing process.

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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

Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
Effective Batch Record Review – Getting It Right The First Time January 8 - 8, 2020
1:00pm - 2:30pm EST, Online Training
Clinical Research Project Management - 7 Breakthrough Behaviors For Success January 14 - 14, 2020
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error January 15 - 15, 2020
1pm-2:30pm EST, Online Training
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TRAINING COURSES

Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
Effective Batch Record Review – Getting It Right The First Time January 8 - 8, 2020
1:00pm - 2:30pm EST, Online Training
Clinical Research Project Management - 7 Breakthrough Behaviors For Success January 14 - 14, 2020
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error January 15 - 15, 2020
1pm-2:30pm EST, Online Training
More Upcoming Courses