Newsletter - 0518-05
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#0518
 
 
Top Articles
 
 
A Life Too Short
 
Countless rare diseases remain uninvestigated by big pharma, leading non-profit organizations to step up to the challenge themselves. In the case of the Progeria Research Foundation (PRF), their efforts have resulted in gold!
 
 
 
 
A New Supporter
 
Initially, The American College of Rheumatology (ACR) urged caution around the use of biosimilars. But in February 2018, The ACR published a white paper to educate its members about and support the use of biosimilars.
 
 
 
 
Staying on Target
 
Researchers from the H. Lee Moffitt Cancer Center & Research Institute have combined mathematical modeling and single-cell imaging to better understand what drug properties make for more efficient drug uptake.
 
 
 
 
 
 
 
Webinar
 
 
Cell Therapy Facilities – Designing for Flexibility, Scalability, and Cost Effectiveness
 
Looking to find out more about designing cell therapy facilities? In this webinar, experts give an introduction to the topic, discussing what operational, technical and support spaces are required, and how GMP and biocontainment requirements impact design. Mechanical and electrical needs – and how to address them – will also be considered.
 
 
 
 
Trials of a Medicine Maker
 
 
Asking the Right Questions
 
Eva likes to ensure her new suppliers are all on the ball (rather than relying on a dubious crystal ball)
 
 
 
 
White Papers
 
 
Understanding excipient functionality in a formulation
 
The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Active Pharmaceutical Ingredient (API) and excipients that define the performance of the product.
 
 
 
CordenPharma White Paper > Battling Counterfeit Medicine Through Packaging Serialization
 
Get informed about packaging serialization regulatory requirements & deadlines with keys to combating the worldwide drug counterfeiting problem. Topics include supply chain serialization techniques such as Microscopic RFID Tags, Security Labels, Invisible Inks, and Track-and-Trace Technologies. Learn how choosing the right CDMO ensures the utmost support in keeping patients safe.
 
 
 
The advancement of Roller Compaction, the manufacturing method that continues to gain importance.
 
David O’Connell at PCI Pharma Services discusses the advances of dry granulation as an alternative to traditional wet granulation for the development and manufacturing of solid oral dosage forms, including tablets and capsules.
 
 
 
 
Product Profiles
 
 
Non-destructive pharmaceutical package testing
 
Check seal integrity for improved product packaging quality with reduced risk of contamination using the Dynascan MediTEST. The system offers both accurate and reproducible detection of leaks down to 15 microns in size (for up to ten packages simultaneously) with 21 CFR part 11 compliant LabVIEW software.
 
 
 
Quali-V®, the trend in market preference, ideal for solid oral drug development
 
Quali-V® is the original 100% plant-based capsule developed specifically for pharmaceutical use, with proven functionality and performance over time and for diverse formulations. Compared to gelatin, it offers reduced moisture content and water permeability, minimal brittleness and static charge, and is chemically inert, making Quali-V® capsules ideal for new developments.
 
 
 
OptiShell® Innovative Softgel Technology
 
OptiShell® technology expands the capabilities of softgel formulations, allowing higher-temperature encapsulation of a wider range of fill materials to provide additional solutions for solving unique drug delivery challenges.
 
 
 
 
Special Promotions
 
 
PCI Pharma Services is heading to Biotech Outsourcing Strategies CMC, Basel, Switzerland
 
By involving our experts early in the strategic development of your new product, we can assist in optimising the process, ensure regulatory hurdles are minimised and the most efficient routes to clinic are delivered. To arrange a meeting email: sales@pciservices.com
 
 
 
Stay Ahead. Smart Risk Management
 
As supply chains become increasingly complex, collaboration between biopharmaceutical customers and suppliers is crucial for supply continuity and control.
 
 
 
The Continuous Way
 
Why adopt continuous bioprocessing? Because it can lead to faster and more cost-effective biopharma manufacturing. In this supplement, Pall and their collaborators discuss the benefits of continuous bioprocessing and how Pall is innovating in this area.
 
 
 
 
Events
 
 
Upcoming Events
 
Be it a large congress at a huge venue or an expert meeting that fits around a table, these events are a fantastic way to network and educate yourself on the latest developments in the industry – so why not take a look at our list of upcoming events?