Understanding the Hidden Costs of Weak GMP Documentation and the Return on Investment for Strong GMP Documentation

In your experience, when an organization has invested in proper documentation, what have the results been like?

The results have been tremendous!

We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements.

In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients.

To learn more about GMP documentation, check out the ebook by Bulletproof below! 

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CRYSTALOMICS: A PATHWAY FORWARD FOR PROTEIN CRYSTALLIZATION

Protein-based therapeutics, specifically monoclonal antibodies (mAbs), have become the focus of pharmaceutical R&D over the last decade. While these biologics offer many possibilities when it comes to treating a variety of diseases, they also present considerable challenges during development.

All of these factors combined make manufacturing and delivery of protein-based therapeutics very difficult. If these drugs could be produced at lower viscosities, then a lower volume could be used, making subcutaneous delivery possible; this would also significantly reduce the risk of aggregates. Now, a treatment that typically requires an hour in a clinic could potentially become a simple injection at home.

This informative white paper by Althea covers the challenges of crystallization of proteins for therapeutic use and how to preserve efficiency during crystallization.

Learn more about a pathway forward for protein crystallization in the white paper below! 

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Managing Your Cold Supply Chain to Ensure Your Vaccinations Get to Where They’re Needed Most

World Courier is transporting Zika diagnostic test kits to and from South America.

Companies trust us to transport and store time- and temperature-sensitive products, and the urgent and sensitive Zika diagnostic test kits are no exception! In the midst of concerns, especially for the well-being of athletes, World Courier’s capability and expertise are another reason to have peace of mind.

The Zika virus was a huge fear for the 2016 Olympic summer games in Rio de Janeiro, Brazil. In the white paper below, World Courrier explains the process and challenges of transporting Zika tests for the 2016 Olympic games to ensure the safety of the Olympic athletes and those attending.

Take a look at the full white paper below!

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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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Tomorrow’s Medicine: Curing One Patient at a Time

You know that tomorrow’s medicine is personalized. With more than 8,100 active cell therapy studies and 1,300 active gene therapy studies underway now, you’re changing the way patients will be treated.

To achieve the best clinical outcomes, the living cells and biological samples you develop or treat must be transported to patients on time and under the most rigorous product and stability specification. Anything less than perfect is unacceptable.

The World Courier eBook below highlights the logistics challenges of gene and cell therapies. Download the full eBook below for more information! 

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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

 

 

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!

 

 

Managing A Cold Supply Chain

In the build up to the American Biomanufacturing Summit, we sat down with James Klingelhoefer, Regional Sales Director at World Courier to discuss strategies to best manage a cold supply chain. In the article below, James discusses the challenges and opportunities in managing a cold supply chain, explains the most important elements to manage and provides advice to biomanufacturers who may be struggling with their cold supply chain management.
world-courier-infogracphicManaging a Cold Supply Chain

To hear more biomanufacturing insights, join the discussion on May 10 – 11, 2016 in San Diego, CA.