EDITOR'S DESK

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.

How These Biosimilar Unknowns Could Impact Manufacturers

During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.

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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

  • A Growing Number Of Pharmas Are Thinking Outside The Box
    A Growing Number Of Pharmas Are Thinking Outside The Box

    Everyone knows the mantra – reduce, reuse, recycle – but reusing temperature-sensitive packaging has not been the normal practice in the pharmaceutical/life science sectors. However, changes are afoot.

  • BIO 2016 Survey: Where Is Biopharma Headed?
    BIO 2016 Survey: Where Is Biopharma Headed?

    15,937 industry leaders, 40% of which were C-level executives, attended the BIO International Convention in San Francisco that ran June 6-9. The MilliporeSigma team used this opportune gathering of the biopharma industry to unveil the findings of a study that it recently sponsored with The Economist Intelligence Unit, titled The Changing Biopharma Risk Equation.

  • 5 ADC Manufacturing Challenges You Need To Know
    5 ADC Manufacturing Challenges You Need To Know

    The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising treatment in the fight against cancer. According to recent analysis, experts anticipate the ADC market to be worth $10 billion annually by 2025. However, despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.

  • The Future Is “Cloudy” For Data Integrity In Life Sciences
    The Future Is “Cloudy” For Data Integrity In Life Sciences

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.

  • Selecting The Optimal Resins For Aggregate Removal
    Selecting The Optimal Resins For Aggregate Removal

    The success of any biologic drug, for example, monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream purification. Among the challenges process scientists often face during this process is the formation and/or removal of aggregates of monomers.

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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