Using just three types of refrigerants and four shippers to create 12 solutions, the Certis® 2-Day Platform maximizes the number of solutions while minimizing the number of components. The new platform is sized to accommodate 7, 13, 27 and 56 liters of product. Each of the new solutions feature a year round pack-out designed for use in both hot and cold seasons.
Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines. Many companies are outsourcing activities that have historically been kept in house, freeing themselves to concentrate on their core competencies and become more agile in responding to changing conditions. These new outsourcing models include discovery and R&D, regulatory, chemistry and manufacturing controls (CMC) support, and back office sales and marketing activities—virtually no activity is out of bounds. Instead of building or acquiring specialized technologies and facilities, many companies are seeking access to them elsewhere. Smart outsourcing provides the following operational and business benefits:
In your experience, what has the outcome been like when an organization has taken the time to improve its’ single-use strategy?
The first thing people sigh in relief about is that there is no danger of breathing in particles and that they are dispersing all over the manufacturing facility. Once the system is closed, there is no longer so much time spent on cleaning and validation. In addition, it helps speed up the process making it so there is one less bottleneck on the road to continuous manufacturing.
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.