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.
Upstream virus production for vaccine manufacturing is typically performed in stirred-tank bioreactor systems, but rocking bioreactor systems offer the benefits of low minimum working volumes that can shorten the seed train prior to inoculation, and agitation can be adjusted to a smooth rocking motion for optimized growth of sensitive cells. This application note describes the production of adenovirus in HEK293 suspension cells in a rocking bioreactor. Triplicate cultures demonstrate a reproducible and robust batch production of adenovirus.
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.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process. The study performed is a collaboration with Celgene and GE Healthcare with a view to replacing their three-step affinity chromatography purification protocol with a more rapid method. An alternative one-step approach was devised to shorten time to results while still providing the purity (> 90%) and yield (> 85%) required for manufacturing of BsAb constructs.
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.
In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.
Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.