EDITOR'S DESK

  • Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations
    Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

New U.S And Canadian Facilities Boosting Biologics Capacity

Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

2018 Outlook: Biosimilar Trends To Watch

Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

More From Our Editors

GUEST CONTRIBUTORS

  • When To Use A Fishbone Diagram … And Why You Should Do It More Often Than You Think
    When To Use A Fishbone Diagram … And Why You Should Do It More Often Than You Think

    The previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act and when to let your processes run without interference. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.

  • 5 Strategies To Combat Counterfeit Drugs And Other Pharma Supply Chain Threats
    5 Strategies To Combat Counterfeit Drugs And Other Pharma Supply Chain Threats

    Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. If anything, the problems will tend to multiply as transnational clandestine operations continue to be involved in the highly lucrative counterfeit drug market. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.

  • CMC For Cell & Gene Therapies — 4 Topics To Discuss During Pre-IND Meetings With FDA
    CMC For Cell & Gene Therapies — 4 Topics To Discuss During Pre-IND Meetings With FDA

    Seeking early guidance from regulators can be invaluable when navigating preliminary product development strategies. The need for feedback increases significantly when working with cell and gene therapy products (CT/GT). These therapies, once considered a kind of “wild-west,” are becoming more widely accepted. Still, the task of seeking approval from the FDA can be extremely challenging. It’s become vital to get your relationship with the FDA off to a solid start from day one.

  • Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?

    In the global biosimilars industry, regulations are administered locally, on a country-by-country basis, inevitably leading to inefficiencies and contradictions in regulatory requirements for biosimilar approval from one country to the next. If those inefficiencies are too great, some companies may delay or forego entirely seeking approval in a jurisdiction where the costs or uncertainties of the regulatory path are too high. 

  • A Standardized Approach To Classifying Visible Particles In Parenteral Products

    The presence of visible particles in parenteral biopharmaceuticals remains a hot topic in the industry. Despite regulatory bodies targeting a goal of no visible particles, and despite industry’s focus on further improving the efficacy of inspection processes, particles will continue to be found during production and in the marketplace.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • 5 Reasons External Collaborations Fail In Drug Discovery

    This white paper, brought to you by Dassault Systèmes BIOVIA, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.

  • Connection Technology Advances Closed System Processing

    The global demand for new biologics and vaccines, combined with the growing emergence of biosimiliars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective. By John Boehm, Colder Products Company

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • What Are Exosomes?
    What Are Exosomes?

    Gain an understanding of  exosomes which are recently attracting attentions of researchers as new mediators of cell-cell communication transporting biomolecules such as lipids, proteins, and RNAs in vivo.

  • Expand Capacity In Buffer Management
    Expand Capacity In Buffer Management

    Biomanufacturing requires large volumes of buffers, and preparation of these liquids can quickly become a bottleneck. Here, two options that can help intensify your large-scale buffer management are presented.

  • Useful Tips For Fab Protein Purification
    Useful Tips For Fab Protein Purification

    While protein purification is a well-established, conventional and highly trusted discipline, the approaches it employs can be as diverse as its targets.

  • Tufts Study Uncovers The Economic Advantage Of Single-Source Drug Development And Manufacturing
    Tufts Study Uncovers The Economic Advantage Of Single-Source Drug Development And Manufacturing

    With patient care at the forefront, it is critical to assess the economics of both outsourcing models and ensure the one you select provides the most efficient path to commercialization. This was the purpose of a recent study by the Tufts Center for the Study of Drug Development (CSDD), which compared cycle times and development economics between multi- and single-source CDMO models.

  • Pharma Liquid Filling Systems — Comparison And Selection Guide
    Pharma Liquid Filling Systems — Comparison And Selection Guide

    Having sold filling lines for all types of liquid pharmaceutical products (hundreds of lines in aggregate), Bosch Packaging Technology is in a unique position to advise on filling system selection.

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LIFE SCIENCE INDUSTRY EVENTS

How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency October 16 - 16, 2018
1pm-2:30pm EDT, Online Training
Life Sciences West Coast Compliance Congress October 17 - 18, 2018
San Francisco, CA
Speed to IND for Biologics October 17 - 18, 2018
San Fransisco, CA
Basket & Umbrella Trials for Clinical Oncology October 17 - 18, 2018
Philadelphia, PA
24th Annual Validation Week October 22 - 24, 2018
San Diego, CA
More Industry Events

TRAINING COURSES

How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency October 16 - 16, 2018
1pm-2:30pm EDT, Online Training
Stability Programs - Key Factors in Meeting FDA/ICH Expectations October 25 - 25, 2018
1pm-2:30pm EST, Online Training
Medical Devices - Effective Complaint Handling and Management November 2 - 2, 2018
1pm-2:30pm EST, Online Training
The Investigational New Drug (IND) Submission – Tips to Win the First Time November 2 - 2, 2018
1pm-2:30pm EDT, Online Training
Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 5 - 5, 2018
1pm-2:30pm EST, Online Training
More Upcoming Courses