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.
Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.
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.
Using rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using a rocking bioreactor system.
Ensuring your material is stored under appropriate conditions is only half the battle in preserving its integrity. Equally as critical is the precarious process of transporting your material to its destination, safely and in the same condition it was sent in. Maintaining the chain of custody is of utmost importance, and a large component of this is based on the vessel selected for transportation. In this article, we’ll share some key items to consider when selecting shippers to transport your high value material.
Bispecific antibodies (BsAb) can, in early screening phases, be purified using protein A chromatography in a single step. In this study, BsAb constructs were efficiently purified using a one-step approach, saving 4 to 6 weeks.
Gone are the days when medical consumers would settle for just one formulation of a medication. Keeping an eye on some emerging trends that are shaping society and the pharmaceutical industry can help you meet those diverse consumer preferences and potentially extend the lifecycle of their products.
When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.
One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.
Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.
Organizations need to manage chemicals safely from receipt to disposal along the entire lab-to-plant value chain, ensuring Environmental Health and Safety (EH&S) compliance across the enterprise.
Developed with Aprecia’s proprietary 3DP manufacturing process, ZipDose® Technology helps patients who need medicines that are easy to take and caregivers—including physicians and nurse practitioners—who want medicines that are easy to administer. By enabling delivery of high-dose medications in a rapidly disintegrating form, ZipDose overcomes patient adherence and difficulty swallowing challenges.
Data-driven risk assessment enables smart decisions on development strategy.
The complexity of high cost biologics means comparator may be one of the highest line items in your clinical trial budget. Our Comparator Center of Excellence Team can consult and assist you in managing the full breadth of your comparator sourcing needs. Utilizing Fisher Clinical Services’ comparator sourcing services will provide you access to a global sourcing network and an overall de-risked supply chain. Currently 15 out of the top 20 worldwide pharmaceutical and biotechnology companies, as well many small pharmaceutical and biotech start-ups, actively utilize our comparator sourcing and strategy services.
This XDR single-use bioreactor is sized for the benchtop, yet allows smooth scale-up to full production.
