FROM THE EDITOR

Shaping The Emerging Biosimilars Landscape

The emergence of biosimilars in the U.S. will  undoubtedly have a marked impact on the pharmaceutical industry, but the market is young and malleable. Pharmaceutical manufacturers currently have a unique opportunity to shape perceptions and use of biosimilars among healthcare providers and their patients.

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PHARMA MANUFACTURING INSIGHTS

  • Revisiting Manufacturing Facility Design: A CFO Takeaway
    Revisiting Manufacturing Facility Design: A CFO Takeaway

    Manufacturing facilities in the pharma industry may set a high bar for complexity and capital density as compared with the wider industrial community. Therefore, you might expect that the process of design for these complicated facilities would be a top priority from the earliest stages of a project. 

  • Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era
    Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era

    The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.

  • Safety First: Advancements In Child-Resistant Packaging
    Safety First: Advancements In Child-Resistant Packaging

    Child-resistant packaging is one of the best-documented successes in preventing the unintentional poisoning of children, but drugmakers have long been limited to using rigid form factors to meet PPPA requirements. However, new developments in flexible child-resistant packaging could change that.

  • Detection of Microbial Contamination in Sterile Containers using Headspace Analysis
    Detection of Microbial Contamination in Sterile Containers using Headspace Analysis

    Sterility testing in the pharmaceutical industry has long been based on growth media culture methods. The general approach is to incubate for 14 days and then determine potential contamination with a visual inspection of the media sample

  • Container Closure Integrity of Sterile Vials During Deep Cold Storage
    Container Closure Integrity of Sterile Vials During Deep Cold Storage

    Certain sterile pharmaceutical products require deep cold storage, either at dry ice (-80°C) or even cryogenic (−196 °C) temperatures. 

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PHARMA CONTRIBUTING EDITORS

  • Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?
    Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market?

    Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?

  • Making The Switch To Single-Use: Have You Thought Of Everything?
    Making The Switch To Single-Use: Have You Thought Of Everything?

    In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.

  • Is Sustainability Possible With Single-Use Technology?
    Is Sustainability Possible With Single-Use Technology?

    At this point, it is well known that single-use technology (SUT) can offer many benefits to a manufacturer and their facility. However, there are concerns that single-use technology produces too much harmful waste to achieve sustainability. But is this true?

  • Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”
    Could Birth Of “Big Generic” Be Foreshadowing “Big Biosimilar?”

    The past few weeks, the generics market has seen several players jump ship and one company grow significantly — and to some, alarmingly — larger.

  • TPP Negotiations Stall, Hold Back Biosimilars Market
    TPP Negotiations Stall, Hold Back Biosimilars Market

    As if the biosimilar naming debate between brand-name pharmaceutical companies and generic drugmakers wasn’t enough, these two sides continue to challenge each other — this time, over biologics data exclusivity in the ongoing Trans-Pacific Partnership (TPP) negotiations.

More From Pharma Contributing Editors

PHARMACEUTICAL ONLINE VIDEOS

  • An Alternative To Large Rotary Evaporators

    The ROCKET 4D from Genevac is a new fully automated system for drying or concentration of very large volumes (up to 100 litres) in one operation with no user interaction. Simply load your sample, select a method, press start, and walk away – the system will do the rest, allowing you to be more productive.

  • Video: Welding AL-6XN
    Video: Welding AL-6XN Welding AL-6XN is a very similar process to welding other stainless steels, but there is one very important exception. This alloy requires an additional alloy to be consumed in the weld. Click the link to see a video that outlines these and other instructions for welding AL-6XN successfully.
  • Video: Steam-Thru® II Connections Video: Steam-Thru® II Connections
  • Beckman Coulter Optima X-Series Ultracentrifugation At Pittcon 2012
    Beckman Coulter Optima X-Series Ultracentrifugation At Pittcon 2012 Randy Lockner discusses the Optima X-Series. Internally, enhancements were made to the drive and the cooling system to improve efficiency and sound level.
  • Video: PAPPIS Transferring Ovals

    The PAPPIS is Viswill’s new Plug And Play Portable Inspection System designed specifically by our customers.

More Videos

INDUSTRY NEWS

  • Wireless System Protects Valuable Medical Inventory Stored In Freezers And Coolers

    The WSG30 system from Sensaphone, a leader in monitoring technology, provides low-cost 24/7 remote monitoring of freezers and coolers that contain pharmaceutical products, medical specimens and research material. It is ideal for pharmacies, research labs, blood and tissue banks, hospitals, healthcare clinics, and biopharmaceutical companies.

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FEATURED SUPPLIERS

  • Cook Pharmica
    Cook Pharmica

    Cook Pharmica is an integrated contract development and manufacturing organization that simplifies the supply chain needs of its customers. By offering a unique solution of providing support from drug substance through drug product and packaging all under one roof with one management team and one quality system, Cook Pharmica helps pharmaceutical companies mitigate their risk and avoid complicated technical transfers. Cook Pharmica also operates as a strategic partner with customers, freeing them up to focus on their core competencies, which typically include research and development of new products. By taking advantage of Cook Pharmica’s one source, one location model, pharmaceutical these companies can better leverage their budgets, simplify their supply chain needs, and achieve greater speed to market.

  • Pfizer CentreSource
    Pfizer CentreSource

    Pfizer CentreSource (PCS) is a leading pharmaceutical contract manufacturer that offers a range of GMP compliant sourcing and outsourcing services to meet your pharmaceutical production requirements.

  • Advanced Test Concepts (ATC Inc.)
    Advanced Test Concepts (ATC Inc.)

    Advanced Test Concepts, Inc. (ATC, Inc.) has offered our customers high quality, innovative and affordable Test & Measurement products for more than 20 years.

  • Capsugel
    Capsugel

    Capsugel offers capsules for the pharmaceutical and dietary supplement industries in multiple polymers — gelatin, HPMC, and pullulan.

INDUSTRY PARTNERS

 

 

PHARMACEUTICAL ONLINE SUPPLEMENTS

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Using Social Media for Patient Recruitment in Clinical Trials

September 3, 2015
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