Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. As global guidelines take full effect, it is worth understanding how contract manufacturing organizations are preparing themselves to comply to meet the needs of their customers.
While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation within the company and serialization efforts in place?
The speed-accuracy trade-off is a well-known phenomenon in psychology for processes requiring human input: the faster you go, the more likely it is that errors will be introduced into the system. This presents a major challenge for complex supply chains that demand both efficiency and accuracy. This case study shows the steps Fisher Bioservices took to improve efficiency and accuracy to combat the complexities of the drug receipt process.
The growing adoption of single-use (SU) in all process steps of cGMP clinical and commercial production requires enhanced assurance of supply and robust product performance. This innovative bioprocessing bag technology is designed to meet the new challenges of assurance of supply and consistent performance for every process step and application of biomanufacture.
The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.
Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this article, we’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.
This video demonstrates how the VIA Thaw CB1000 can standardize a critical step in the delivery of cell therapies with a simple, reproducible and traceable process for recovering cryopreserved samples in cryobags.
A video introduction on the VIA Freeze™ range which are liquid nitrogen-free controlled-rate freezers to cryopreserve any type of samples.
An overview of the regulatory requirements given in the latest guidance documents as well as a description of new technologies for determining the identity of cell substrates and virus seed stocks and detecting adventitious agent contamination.
Rapid growth and geographic expansion in the biopharmaceutical market is increasing supply chain risks that need to be well understood.
Learn more about how free trade zones can offer cost-efficient ways to manage your clinical trial.
AbbVie Contract Manufacturing offers development to commercial manufacturing services for prefilled syringes at our Barceloneta and Lake County facilities. Barceloneta is one of the world’s most advanced facilities for biologics syringe filling and Lake County has broad packaging services from blister packs to auto-injectors.
Fill-finish syringe manufacturing is one of the last steps in pharmaceutical commercialization. The goal here is efficiency and sterility. Companies don’t want to waste any of their carefully developed product and they don’t want to distribute poor quality prefilled syringes or contaminated formulas. Once established, high syringe manufacturing standards must then be maintained throughout the drug’s life span, to deliver a reliable supply for patients.
Changes to the protocol such as dosage changes, increases or decreases in volumes, changes to expiry dates, or inclusion/exclusion of countries that weren’t part of the original plan can impact clinical trial packaging. You need a partner that can help you accurately identify and predict issues that might impact schedules, while remaining nimble to adjust to changes. Read how Fisher Clinical Services can serve as a trusted advisor to help you strike the best balance of cost, time and quality.