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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How Medical Device Manufacturers Can Optimize Quality, Lower Costs, and Increase Efficiency

Medical device manufacturing has minimal tolerance for error—and quality is of the utmost importance. If your products don’t deliver what you promise, lives can be at stake. At the same time, product returns erode your profit margins, while customer satisfaction can make—or break—your reputation. For companies with unique patented products, meeting demand puts added pressure on every stage of your supply chain.

This white paper by the Copley Consulting Group explains how you can make a commitment to lean processes while raising your quality standards, improving efficiency, and driving down costs. It’s important to create efficiencies in your manufacturing processes, but this often involves taking small incremental steps.

Find out more about educating your organization about these opportunities, driving down costs, and systematically removing waste and uneven workloads from your manufacturing processes below:

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eBook: Realistic Simulation for Medical Device Developers

Medical device developers use realistic simulation solutions from SIMULIA to accelerate the overall product innovation process, reducing development costs, and improving patient safety and product quality.

In addition, SIMULIA provides medical device companies with the ability to more efficiently evaluate design alternatives, accelerate long-term stress life testing to predict product reliability, collaborate on projects and leverage computing resources for more efficient design analysis.

Check out the eBook below!

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eBook: Product Content Management in a Regulated Environment

In today’s environment of strict regulation and reduction in spending for healthcare, life sciences companies are under pressure to reduce operational costs, increase efficiency and provide greater value to the system—and sales enablement is a crucial component to achieving all of the above.

In the eBook below, Seismic addresses some of the challenges that life sciences companies face and provides some solutions to these challenges.

Check out the eBook below!

 

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What Happens When Life Sciences Messaging Doesn’t Meet FDA Regulations

Medical device organizations face a number of regulatory and compliance challenges ranging from design and development to commercialization.  In preparation for the American Medical Device Summit 2016 we wanted to share the post below to introduce some of the challenges that can arise when life sciences messaging doesn’t meet FDA standards.

The Seismic blog post below discusses some common missteps life sciences marketers make when it comes to FDA compliant messaging, and the consequences to distributing non-compliant medical product promotional content. It also offers some simple solutions for avoiding those missteps.

Check out the post!

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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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eBook: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

Medical device manufacturers are operating in a constantly evolving environment. Aging populations, evolving healthcare systems and more stringent regulations will have a significant impact on how medical device developers operate and succeed in the years to come.

With the American Medical Device Summit quickly approaching, we wanted to take a closer look at how medical device developers will be able to navigate and thrive in this shifting terrain.  Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services, generated the eBook below to help developers address their most pressing challenges and enable a new collaborative model.

Check out the eBook!

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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!

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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!