EDITOR'S DESK

  • Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

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?"

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GUEST CONTRIBUTORS

  • Why Data Integrity Is Impossible Without A Quality Culture
    Why Data Integrity Is Impossible Without A Quality Culture

    Quite a bit has been written about data integrity in recent years, and an embedded, effective quality culture remains a critical success factor for fully realizing strong data integrity. In recently published guidance on data integrity, the FDA goes so far as to state very directly that “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues.”

  • Reimagining Quality Operations In The Life Sciences
    Reimagining Quality Operations In The Life Sciences

    This is the third of three articles focusing on an effort to address what appear to be systemic issues across quality departments, informed by a multinational group comprising chief quality officers (CQOs) from pharma, device, animal health, and consumer goods companies. It will examine how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.

  • How Technology Will Reshape The Future Of Aseptic Processing
    How Technology Will Reshape The Future Of Aseptic Processing

    Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring. In some cases, improvements to these approaches will require the use of existing technology. In other cases, they will be required to support the implementation and use of new technology.

  • How To Write An Effective Validation Master Plan

    A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

  • Overcoming The Unique Filling Challenges Of Autologous Therapies

    Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

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BIOPROCESSING WHITE PAPERS

  • Cell Therapy Logisitics

    Having a sound logistics strategy is critical to ensuring this living drug is delivered to the right patient at the right time, location, and temperature is essential to patient safety and product effectiveness.This paper will walk through key considerations for developing a successful logistics strategy for the management of cell-based material.

  • Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

    This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

cGMP Compliance - Understanding The Top Drug Enforcement Trends February 26 - 26, 2019
1pm-2:30pm EST, Online Training
PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
More Industry Events

TRAINING COURSES

cGMP Compliance - Understanding The Top Drug Enforcement Trends February 26 - 26, 2019
1pm-2:30pm EST, Online Training
Best Practices in CMC Dossier Preparation – Facing Tough Challenges March 15 - 15, 2019
1pm-2:30pm EDT, Online Training
Developing a Part 11 Compliance Plan in Clinical Research March 26 - 26, 2019
1:00 PM - 2:30 PM EDT
More Upcoming Courses