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.
Today, manufacturers are optimizing open-suite facility design to maximize throughput and profitability. Key to this initiative is minimizing product loss due to feedstock spills, waste and cross contamination. Improving the safety of workers is also a driving factor, through reduced exposure 10 to airborne particles and lowering the risk of particle ignition. In order to accomplish both, a highly efficient powder transfer and containment system is required — one that is designed exclusively for powders, not one adapted from a liquid transfer system.
The EZ BioPac® single-use system is the fastest, most efficient solution. Its larger diameter top opening permits easy filling and fine-tuning of final weight. It is suitable for a wide range of filling/ dispensing volumes, flow rates, and product weights. Plus, its rugged, disposable transfer bags feature anti-static properties, assuring fast, complete discharge into process vessels.
Many biopharmaceutical manufacturers are Implementing single-use containment and transfer of media and buffer materials to prevent feedstock contamination and to promote worker safety. Choosing the proper containment system can have a significant impact on productivity and profitability.Solutions such as the EZ BioPac® system from ILC Dover® lessens the amount of powder that disperses into the air substantially, thereby lowering the risk of cross-contamination. Reducing the amount of contamination, in turn, reduces the time needed for changeover, lowers staff costs, and frees staff to work on more vital jobs, which all contribute to profitability.
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.
This Q&A eBook with OQSIE will delve into:
- three batch validation;
- regulatory compliance in product development and quality systems; and
- how to lead an integrated QbD implementation strategy.
OQSIE will also be discussing these topics at a Lunch & Learn at Generis’ American Biomanufacturing Summit taking place May 23-24th in San Diego, CA.
Read the full ebook in the link below!
Dan Simon, President & CEO of Heliae Tech. Holdings Inc. discusses the last 5 years of the company and creating a platform to grow economically viable algae. Now they are applying it into four basic categories; Therapeutic drugs, Cosmetics, Nutraceuticals and Agriscience.
View the full video below!
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.
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.
Organizations entering into an ERP project begin their journey by making a business case for ERP. The effort involves determining an expected return on investment, anticipating total costs and fully documenting the business case for investing in a new or upgraded system.
This can’t-miss paper makes the case that it is critical to document the business reasons for an investment in ERP. You’ll see the reasons to calculate the expected value to offset the cost. Identifying risk is part of the process, as is putting in plans to mitigate risk.
This white paper by Ultra Consultants will identify five considerations to keep in mind when justifying an investment in ERP leveraging Ultra Consultants’ experience in helping manufacturers with this process.
View the full white paper below!
Bill Remy is Chairman and Chief Executive Officer at TBM Consulting and a member of the Board of Directors. He has 30plus years of leadership experience in general management and manufacturing operations. Bill’s areas of expertise include operational performance improvement through LeanSigma deployment in manufacturing operations, supply chain, product development and project management. He has experience in a broad array of business leadership positions across various industries including aerospace and defense, railway, industrial and agricultural equipment, technology and process automation. Bill returned to TBM in the summer of 2011 after working at Invensys as Vice President, Continuous Improvement. Prior to Invensys, Bill led the initiative
Bill returned to TBM in the summer of 2011 after working at Invensys as Vice President, Continuous Improvement. Prior to Invensys, Bill led the initiative.
This Q&A eBook with Bill Remy will touch on the ways that technology is transforming the manufacturing and supply chain industries, lean manufacturing, technology investments, and best practices for manufacturing managers.
Read the full eBook below!