EDITOR'S DESK

  • What To Know About Emerging Market Biosimilar Pathways
    What To Know About Emerging Market Biosimilar Pathways

    The emerging markets have been making strides in developing pathways for the approvals of biosimilars. However, there are several considerations companies need to keep in mind when putting together a dossier for market approval in Russia, Colombia, Peru, and Malaysia.  

BsUFA II: What Biosimilar Makers Need From FDA

The past few months, biosimilar makers, trade organizations, and the FDA have been hard at work on BsUFA reauthorization negotiations. Biosimilar makers’ needs have changed since BsUFA’s launch in 2012. The newest version of BsUFA is slowly being renegotiated in the hopes of better reflecting the current and future state of the changing biosimilar market.  

4 Takeaways From The World Biosimilar Congress

Throughout this whirlwind two-day event, the panelists addressed the challenges of patient education and uptake, the pharmacovigilance of biosimilars, and how to navigate varying regulatory requirements in the global market. But there were four key messages relayed throughout this conference that are worth noting.

Navigating Brazil’s Emerging Biosimilar Market

The Latin American markets, and especially Brazil, hold great promise for biosimilar development, PlantForm CEO Don Stewart says. In recent years, many partnerships have been launched in Brazil between local and international companies to bolster the country’s biosimilar development. However, there are a number of things companies looking to forge joint ventures in Brazil need to keep in mind for success.

Some Biopharma Haven’t Caught Outsourcing Enthusiasm

I often write – and you read – about those individuals at biopharma companies openly enthusiastic about outsourcing. Not too long ago, though, I ran into a person who seemed to outdo the others in absolute embrace of this model. But here’s the catch: Her company won’t allow her enthusiasm to be shared “on the record.”

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GUEST CONTRIBUTORS

  • An Introduction To Biopharmaceutical Facility Design & Layout
    An Introduction To Biopharmaceutical Facility Design & Layout

    Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance.

  • A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers
    A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers

    The European Medicines Agency (EMA) is constantly adjusting its regulations, annexes, and guidances in responses to the needs of the industry, and the last 12 months have been no different. During this period they have issued a total of three revisions to established annexes and also issued a brand new guidance document in the GMP world. This article will focus on these four documents and describe what has changed and what it means to pharmaceutical companies.

  • Risk-Based Approaches To Establishing Sample Sizes For Process Validation
    Risk-Based Approaches To Establishing Sample Sizes For Process Validation

    Using confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are proven methods to ensure validation activities will yield valid results based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements.

  • Taking the Long Road to Continuous Manufacturing

    New manufacturing methods that cut processing steps, speed production, improve efficiency and increase quality and safety all sound like great ideas.

  • Effective Risk Management: A Catalyst For Quality Performance

    When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. This guidance laid the foundation for two important concepts that influence how we develop and guarantee the quality of our drug products today.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • Virus Retentive Filtration In Biopharmaceutical Manufacturing

    Virus removal using retentive filters designed to provide effective and consistent clearance of parvovirus (~20 nm) has now become an established standard in downstream purification processes for biologics produced using mammalian cells. Compared to other commonly used virus clearance methods, such as chromatography and low pH inactivation, retentive filtration is superior in its ability to clear almost all potential viral contaminants while also avoiding adverse effects on product quality. While commercially available retentive filters vary in chemical composition and structural configuration, all of these filters primarily clear viruses through the mechanism of size exclusion.

  • White Paper: Utilizing InfoBatch To Generate Clean-In-Place (CIP) Reports Many sterile manufacturing facilities find it difficult to manage Clean-in-Place (CIP) reports and are searching for a solution. InfoBatch is a flexible electronic batch reporting application that can be configured to create and maintain CIP reports for manufacturing facilities. By Informetric Systems Inc.
More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Reducing Analytical Method Steps For Accelerated Product
    Reducing Analytical Method Steps For Accelerated Product

    With an increasing number of products being considered for accelerated development, both the industry and regulators are looking for ways to safely hasten product development and approval times to ensure availability of innovative and low-cost drugs for patients.

  • Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk
    Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    When planning for the development of a new product, a pharmaceutical manufacturer must determine very early in the process what a product’s anticipated demand will be at the time of launch. Not only is this very difficult to do, but also the consequences of incorrect forecasts can be very costly in a number of ways. Without the ability to predict capacity needs with 100% accuracy, pharma must come up with an effective way to eliminate demand risks.

  • Implications Of Inaccurate Forecasting On Biologics Drug Substance Manufacturing
    Implications Of Inaccurate Forecasting On Biologics Drug Substance Manufacturing

    To better understand the issues that biopharmaceutical companies face when planning for clinical and commercial biologic drug substance manufacturing and supply needs, ORC International conducted interviews with biopharmaceutical executives in North America and Europe who consistently utilize forecasts for drug substance and commercial manufacturing planning for biologics. This research explored the causes, consequences, and potential solutions to forecasting challenges specifically related to biologic drug substance manufacturing.

  • Critical Factors of Fill Finish Manufacturing For Biologics
    Critical Factors of Fill Finish Manufacturing For Biologics

    With the explosion of the biologics market, which now accounts for an estimated 20% of all pharmaceutical sales, the industry has entered a new era of drug development. This growth — 10 percent to 15 percent each year — is being driven by monoclonal antibodies, which are anticipated to have worldwide sales of nearly $125 billion by 2021. However, this burgeoning market comes with some considerable challenges for drug manufacturers, due to the fragile nature and instability of these large, complex molecules.

  • The CAPA Detective
    The CAPA Detective

    Every industry has its detectives.  Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs.  Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

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LIFE SCIENCE INDUSTRY EVENTS

Effective Batch Record Review - Getting It Right The First Time June 28, 2016
1pm-2:30pm EDT, Online Training
Effective Clinical Investigator GCP Training - Getting It Right The First Time June 29, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
How to Write SOPs That are GCP Compliant and Implementable July 12, 2016
1pm-2:30pm EDT, Online Training
More Industry Events

TRAINING COURSES

Effective Batch Record Review - Getting It Right The First Time June 28, 2016
1pm-2:30pm EDT, Online Training
Effective Clinical Investigator GCP Training - Getting It Right The First Time June 29, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
How to Write SOPs That are GCP Compliant and Implementable July 12, 2016
1pm-2:30pm EDT, Online Training
More Upcoming Courses