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.
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.
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.
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!
The American Supply Chain Summit is a leadership focused meeting designed around improving supply chain and procurement strategy across the globe.
The Supply Chain Summit serves as an annual platform to exchange ideas and collaborate on the impact of market dynamics and new technologies for current and future supply chain & operations leaders. This year’s Summit creates an opportunity to examine key case studies on how workforce management, advanced analytics, process improvement, and automation are being rolled out in the world’s best facilities. Join the in-depth discussions on achieving innovation, maximizing supply chain profitability, and increasing visibility and flexibility to mitigate risk.
PROFITABILITY & RISK MANAGEMENT
Don’t Miss Out — Register Today!
The book ‘Performance Behavior’ (by Neil Webers) describes how an organization can link performance to behavior to minimize waste and optimize performance behavior.
8 FORMS OF HUMAN-WASTE are outlined which obstruct continuous improvement:
|Leadership-waste||the result from too much push-management (based on authority)|
|Comfort-waste||the result of targets that aren’t enough stretching|
|Communication-waste||the result of misunderstandings that usually originate from meetings|
|Discipline-waste||the result when people are not being held accountable for not adhering to standards|
|Goal-waste||the result of employees having no idea of what is expected of them|
|Engagement-waste||the result of asking people to take responsibility for events or results which they cannot influence themselves|
|Solving-waste||the waste of capacity to solve problems when people work on solving problems without focusing on the root-cause of a problem|
|Tuning-waste||is the waste where people talk about different problems or solutions|
Conducting fact-based negotiations is an effective cost reduction strategy when sourcing components. The infographic below explains how to leverage a product cost management (PCM) platform to conduct more effective fact-based negotiations.
Check out the full infographic below!
aPriori’s product costing software generates detailed cost estimates and connects all members of your product team to relevant views of cost data – from sales to supplier, from concept to customer.
Hear more from aPriori by joining the discussion at the American Aerospace & Defense Summit on December 6-7 in Scottsdale, Arizona.
Early visibility to product cost drivers helps companies eliminate problems before they become extremely expensive to fix.
Watch the following video case study below to hear Bret Armstrong, Manager of the Should Cost team in Cost Performance Engineering at Honeywell, highlight three specific examples that underscore the value of early visibility to cost for everyone in the product value chain from beginning to end.
Read the full article from aPriori here, and watch the video case study below!