EDITOR'S DESK

  • Congress Takes On Biosimilars
    Congress Takes On Biosimilars

    During an interview at a briefing held by The Atlantic and The Biosimilars Council, Senator Bill Cassidy of Louisiana presented some valuable insights into where he believes more work needs to be done to ensure biosimilars’ market success.

FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars

In most cases, the biosimilar guidelines put forth by all the major regulatory agencies are quite similar. But there are some differences that can challenge companies looking to have their biosimilars approved in these different countries. 

The Many Gray Areas Of Biosimilar Commercialization

Commercialization is one of the hottest topics of discussion in the biosimilar industry, perhaps because, so far, the path to commercial success is far from black and white.

How To Approach U.S. Physicians About Biosimilars

As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.

How To Make The Most Of Your FDA Biosimilar Meetings

The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.

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GUEST CONTRIBUTORS

  • Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports
    Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports

    The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry.

  • Rapid Microbiological Methods & Alternatives To Colony Forming Units: A Pathway To Implementation?
    Rapid Microbiological Methods & Alternatives To Colony Forming Units: A Pathway To Implementation?

    The challenges of comparing conventional colony forming units (CFUs) to newer technologies that are capable of counting individual cells or measuring different variables/factors (such as light, shape, or fluorescence) has limited the acceptance and implementation of new technologies in the pharmaceutical industry.

  • Single-Use Chromatography: The Solution To Downstream Processing Bottlenecks?
    Single-Use Chromatography: The Solution To Downstream Processing Bottlenecks?

    Over the last 35 years, the biopharmaceutical industry has accepted, as part of an ongoing process, a wide range of single-use system (SUS) technologies. Initial adoption of filter capsules and plastic tubing has grown in complexity and scale from the early 1980s through today. Now, manufacturers are able to replace most hardware components, including stainless steel vessels/piping/sanitary flanges, and glass vessels, with single-use polymeric devices and components.   Thanks to a large and diverse offering of single-use products, what was once primarily an upstream technology has begun expanding into downstream processes. 

  • Resisting Fragmentation In The Global Serialization Regulatory Landscape

    In 2013, the United States enacted pharmaceutical serialization and traceability requirements under the Drug Supply Chain Security Act (DSCSA). In the years preceding and following passage of the DSCSA, many other countries considered similar regulation for their own markets. Argentina, China, India, South Korea, and Turkey currently require the serialization of pharmaceutical products and the reporting of some type of serialization data. Approximately 40 additional countries — including the U.S., the European Union, Brazil, Russia, and multiple Persian Gulf states — have enacted requirements with future implementation dates or are actively working on requirements.

  • The Nonlinearity Conundrum In Pharmaceutical Facility Design

    In the pharmaceutical and biologics manufacturing community, we’ve been instilled with a unified and rigorous direction with respect to capital project execution. The emphasis is speed, and rightfully so. These projects are among the most complex and costly in facility construction; not to mention that, given the revenue at risk, the overarching focus on speed to market is undeniable. Understandably, the best methodologies of project management — with all its sophisticated tools of the most current thinking — are brought to bear. A strong focus on linear forward progress is always at the fore: initiate, achieve goal one, then goal two … finally finish.

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BIOPROCESSING WHITE PAPERS

  • Controlled Cultivation of Stem Cells – Factors to Consider When Thinking of Scale-Up

    Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.

  • Implementing PAT And Qbd Real-Time Particle Size Measurement For The Pharmaceutical Industry

    As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments

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INDUSTRY INSIGHTS

  • Following FDA Guidance: Continuous Improvement In An Outsourced Environment
    Following FDA Guidance: Continuous Improvement In An Outsourced Environment

    In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”

  • FDA-483 Observations – Implementing A Preventative Approach

    The US Food and Drug Administration (FDA) is responsible for issuing 483 observations to life sciences companies if routine audits find violations, production or quality issues which raise concerns to the safety of the general public. With news stories regularly documenting that an increasing number of organizations are being issued with FDA-483s, often with serious outcomes, avoiding these warnings is a priority and necessitates an understanding of industry requirements, the use of appropriate tools and conducting comprehensive audits.

  • How To Boost Profits With Single-Use Powder Transfer In Biopharma
    How To Boost Profits With Single-Use Powder Transfer In Biopharma

    Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?

  • Increase The Speed To Clinic Of New Biopharmaceuticals With This Approach
    Increase The Speed To Clinic Of New Biopharmaceuticals With This Approach

    The biopharmaceutical market has enjoyed a significant expansion over the past few years. By Hugo DeWitt, Mitch Scanlan, Tim Ward and Christel Fenge

  • CLIA – Clinical Laboratory Improvement Amendments
    CLIA – Clinical Laboratory Improvement Amendments

    Developers of diagnostics devices are faced with the ever-increasing challenge of balancing the drive to create technologically advanced products with the pressures of today’s thrifty healthcare consumers. During the innovation process, the question often arises as to what level of regulation a diagnostic product needs to be designed, manufactured, and tested to. This article provides a brief overview of the requirements and considerations for the clinical diagnostic innovations.

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LIFE SCIENCE INDUSTRY EVENTS

ISBioTech 4th Fall Meeting December 12 - 14, 2016
Virginia Beach, VA
Update to ICH GCP E6 (R2) – Final Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response December 13, 2016
10:30am-12pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations December 14, 2016
10:30am-12pm EST, Online Training
More Industry Events

TRAINING COURSES

Update to ICH GCP E6 (R2) – Final Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response December 13, 2016
10:30am-12pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them December 14, 2016
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations December 14, 2016
10:30am-12pm EST, Online Training
More Upcoming Courses