EDITOR'S DESK

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

Top 5 Biosimilar Developments Of 2017

These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.

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GUEST CONTRIBUTORS

  • Manual Aseptic Processing: The Last Resort Or The Best Approach?
    Manual Aseptic Processing: The Last Resort Or The Best Approach?

    When weighing the operational and product constraints — batch size, container throughput, cost per unit, equipment utilization, facility footprint, cost per square foot, etc. — it is important to consider all of the options available to provide the most effective processing approach for the product manufacturer and, importantly, the best quality product for patients.

  • 4 Future Scenarios For Cell And Gene Therapy Adoption
    4 Future Scenarios For Cell And Gene Therapy Adoption

    Cell and gene therapies are finally becoming a reality, with hundreds of clinical trials underway and some major therapeutic breakthroughs already reaching the market. In the past year alone, the FDA approved its first gene therapy, Spark’s Luxturna for the treatment of a rare form of vision loss, as well as the first two CAR T-cell therapies, Novartis’s Kymriah and Gilead’s Yescarta, for certain forms of blood cancer. While this certainly marks the beginning of an exciting period in the development of cell and gene therapies — the culmination of decades of development — the future impact of cell and gene therapies is uncertain.

  • Education Vs. Experience: Which Is More Important In GMP Operations?
    Education Vs. Experience: Which Is More Important In GMP Operations?

    When looking at most job descriptions in GMP companies, they now require a college degree. This leads to the question: Are we overvaluing educational degrees and undervaluing experience in our hiring practices and position expectations?

  • Summarizing FDA’s New Guidance On Gene Therapy For Hemophilia

    The FDA recently issued six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the final article in a six-part series summarizing each of the draft guidance documents. It will discuss the guidance Human Gene Therapy for Hemophilia.

  • Justification & Qualification Of Visual Inspection For Cleaning Validation In A Low-Risk, Multiproduct Facility

    Proposals for the use of visual inspection (VI) as an analytical method for cleaning validation have been rising for several years now.1 This article discusses regulatory views on the use of VI as a sole criterion in cleaning validation, presents a case study on how inspectors can be qualified for VI, recommends the use of statistical techniques, and suggests how VI could be implemented as part of a control strategy in a cleaning validation program based on the level of risk.

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BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Novel Uses For Oral Solid Doses Driving Lifecycle Management Strategies
    Novel Uses For Oral Solid Doses Driving Lifecycle Management Strategies

    With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.

  • Single-Use Adoption Drives Need For Range Of Sterile Connector Technologies
    Single-Use Adoption Drives Need For Range Of Sterile Connector Technologies

    The adoption of disposable bioprocessing equipment has already been widespread for small-scale applications at the development and clinical manufacturing stages.

  • Finding Solid Ground In New Markets
    Finding Solid Ground In New Markets

    In the recent Economist Intelligence Unit survey on biopharma’s present and future, biopharma industry leaders expressed excitement and some uncertainty about the emerging markets of the Middle East and Africa. Respondents saw great opportunity in these regions, but also cited potential risks in relation to regulatory questions and stability issues. We spoke with Bert de Vet, Head of Commercial EMEA Process Solutions at MilliporeSigma, about his take on growth in the region and some of the ways companies entering these regions can mitigate risk.

  • Purification Of Recombinant F(Ab’)2 Fragments And Their Various Applications
    Purification Of Recombinant F(Ab’)2 Fragments And Their Various Applications

    Fragment antigen binding domains, or F(ab) fragments, are derived from the upper branches of the ‘Y’-shaped antibody molecule. They form the antigen binding interfaces of intact antibodies.

  • Fast-Tracking A QbD Approach
    Fast-Tracking A QbD Approach

    QbD starts with an understanding of the quality target product profile. This allows potential critical quality attributes (CQAs) to be established and a risk assessment performed. 

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LIFE SCIENCE INDUSTRY EVENTS

4th Annual Data Integrity Validation August 15 - 16, 2018
Cambridge, MA
Partnering with IDNs August 15, 2018
Philadelphia, PA
How to Write SOPs That are GCP Compliant and Implementable August 16 - 16, 2018
1pm-2:30pm EDT, Online Training
4th Annual 340B Manufacturer Summit August 21 - 22, 2018
Arlington, VA
Bio/Pharma Forum on the State of Medicare Reform August 21, 2018
Arlington, VA
More Industry Events