Optimizing Temperature Control for Biopharmaceuticals

This article first appeared in BioPharm International, October 1, Caroline Hroncich

Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey.

This article by World Courier delves into these relevant industry topics:

  • Common considerations for shipping biopharmaceuticals;
  • Temperature management in extreme climates;
  • Recent advancements; and
  • Looking ahead.

Learn more about optimizing temperature control for biopharmaceuticals in the article below!  

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Novel Single-Use Systems Allow Faster Powder Transfer and Higher Recovery Rates

Single use powder containment practices are still in their infancy but keeping your product from cross contamination and reducing airborne particulates is important. Understanding how more modern bag designs can increase safety and speed is a concern to the industry. We looked at the ease of fill along with dispensing times and product loss. ILC Dover’s EZ-Biopac shows a 71% decrease in filling times when measured against an industry standard 2D bag. Due to the non-static film we saw an almost 20% reduction in powder discharge times. In addition, it demonstrates a 33.3% improvement in powder recovery showing reduced waste. Choosing the proper containment system can have a significant impact on plant productivity and profitability.

This case study by ILC Dover will delve into:

  • the issues of powder handling;
  • the keys to efficient powder transfer and containment;
  • evaluating potential systems;
  • results; and
  • discharge trials.

Find out more about ILC Dover’s EZ-Biopac below!

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Guide: Medical Device Commercialization

In our previous posts we have looked into some of the challenges that documentation can present during a medical device’s development and production stage. In today’s post we wanted to take a closer look at the challenges that commonly arise in the commercialization stage and explore some simple solutions to overcome them.

Seismic, a leading end-to-end content automation solution provider for life sciences firms worldwide, has created the guide below to help organizations overcome 4 common challenges in medical device marketing.

Check out Seismic’s Guide below: 4-simple-solutions-to-common-life-sciences-marketing-challenges4-simple-solutions-to-common-life-sciences-marketing-challenges

If you are joining the discussion at the American Medical Device Summit this October, don’t forget to stop by Seismic’s booth (# 28) to find out more!

Can you turn Regulatory Compliance into an Opportunity?

Medical device developers are evolving and introducing new products and variants into the market. With this evolution comes a more complex and dynamic global supply chain.  To help navigate this shifting terrain Dassault Systèmes generated the free webinar below to help guide developers through effective techniques to create an opportunity through traceability.

Check out the 35 minute free Qmed webinar on Making Traceability Work for the Business: Effective eDHR and UDI to discover:

  • The role of integrated manufacturing software in eDHR and UDI compliance
  • Approaches to consider for traceability program improvements
  • Questions to raise as you assemble the diverse stakeholders for such a project

Check out the Webinar!

 

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Whitepaper: Beyond the ID, The Value of UDI

There has been a great amount of discussion around the impact that UDIs will have on medical device developers, manufacturers and the health care system at large.  The following whitepaper takes a different approach and looks at UDI implementation from a strategic perspective to assess its true value.  Check out the whitepaper below, generated by Dassault Systèmes and Axendia, to understand where the true value in this system will be expressed.  

 

Beyond the ID, The Value of UDI

 

 

7 Tips for Transitioning to Electronic Medical Device Reporting

In August 2015 the FDA’s Center for Devices and Radiological Health (CDRH) implemented a requirement for manufacturers and importers of medical devices to transition away from paper reporting, and to instead submit adverse event reports electronically.  The electronic transmission of adverse event reports coupled with the mandatory reporting deadlines will allow the FDA to respond more readily to adulterated, misbranded or unsafe devices.  Pilgrim Quality Solutions, created the eBook below to help manufacturers and importers transition to electronic medical device reporting.

Check out the eMDR e-book! 7 Tips for Transitioning to Electronic Medical Device Reporting

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For more medical device strategies, join Pilgrim Quality Solutions at the American Medical Device Summit taking place on October 5-6 in Chicago, IL.

eBook: Medical Device Commercialization Best Practices

The evolving regulatory landscape and the accelerated pace of medical device innovation are increasing pressure on medical device developers to speed their time to market while providing higher quality products,  at less cost.

Navigating this shifting terrain and enabling a quick time to market can often be a challenge. In this eBook, we sat down with Cognition Corporation, compliance and medical device solutions specialists, to gather their insights on the commercialization challenges that medical device developers face and the best practices to overcome them.

Check out the eBook below:

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Medical Device Commercialization Best Practices

 

 

The Benefits of Test Engineering Services for the Entire Product Life Cycle

 

Medical device developers are under increasing pressure to develop new features and better quality products while speeding time to market. One of the ways that developers are achieving this goal is by adopting automation software that will allow them to streamline their product development and test times without sacrificing quality. Averna, a Test Engineering leader, generated the video below to highlight the benefits of automation software and explain how it can help address some of the biggest challenges that medical device developers face.  Check out the video below:

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Whitepaper: Transitioning to Agile

Safety-critical industries face many challenges including stringent regulations and requirements, and increased pressure to speed time to market while improving product quality. As a result, it is often difficult for organizations to move away from traditional development processes and integrate agile methodologies. Seapine Software has generated the whitepaper below to help medical device manufacturers overcome these barriers and successfully transition to agile in a safety-critical environment.

Transitioning to Agile

To hear more from Seapine Software, join the discussion at the American Medical Device Summit taking place this October!

The Serialization Challenge

Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights.

The eBook explores and explains:

  • The Current Regulatory Landscape
  • The Serialization Challenge
  • Best Practices in Serialization
  • Operationalizing a Serialization Program

Check out the eBook below!

clarkston-covereBook, The Serialization Challenge

To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!