Although we are about to officially open our facilities, we have already received the first doses of a cell therapy from a clinical-stage biopharmaceutical company. The therapy will be used to treat clinical trial patients with advanced B-cell lymphoma and acute myeloid leukemia at clinics across the United States. The photos below shows our team in Morris Plains receiving the material recently.
It has certainly been a challenge to construct, fit out, commission, and qualify these facilities in the midst of a global pandemic, however, we are now almost complete, thanks to the dedication and creativity of our exceptional teams in Texas and New Jersey. To view the comprehensive construction build of our two new Global Supply Chain Centers, check out the short time-lapse video below.
Over the last few months, we have been hiring experienced individuals as well as completing an intense program of validation, qualification, and training to ensure our facilities are fully GMP-compliant.
You may ask why is Cryoport Systems launching two Global Supply Chain Centers? Why at these locations, and why now?
Fundamentally, it is because of how the global cell & gene therapy industry is growing and maturing. The growth is rapid – but the supporting infrastructure isn’t. The number of therapy developers are increasing every month, and new types of advanced therapies are emerging and evolving very rapidly. The manufacturing capacity for these unique therapies is limited – which is why many therapy developers have to invest in their own manufacturing facilities, sometimes even to manufacture some of the starting materials used in the manufacturing of their therapy (e.g., viral vector).
The other significant issue is the management of these materials in the supply chain. When the industry was young, the volumes were low, and they could be manufactured in very small quantities and stored at the manufacturing site. However, as the industry continues to grow, the volumes are increasing – clinical trials are advancing from early studies with just a handful of patients to late phase studies involving dozens, sometimes hundreds of patients at multiple clinics, sometimes in several countries.
The therapy developers cannot manage this amount of material themselves – nor do they want to (they want to concentrate on developing and manufacturing the drugs). They need reliable partners, with suitable facilities to help them manage their valuable materials – including the therapeutic materials and the raw materials that are used in the manufacturing process.
This is why Cryoport Systems is launching our new supply chain operations. Cryoport Systems has long been considered a trusted logistics partner to many of our cell & gene therapy clients and many have asked if we could also provide temperature-controlled storage and fulfillment services. Our new centers in New Jersey and Texas have been created specifically in response to these requests and they represent the first steps in building a global network of supply chain centers that provide specialized storage and distribution solutions that will support our clients’ rapidly growing needs.
In addition to providing storage of materials, our facilities are designed to provide specialized drug packaging, labelling, and custom kit production – which in totality we call BioServices - all of the aforementioned services enable the distribution of life saving therapies to patients around the world.
The first step towards providing BioSevices in Europe happened recently when we acquired Cell&Co – a company based in Clermont-Ferrand, France that provides storage and fulfillment services. Cell&Co will serve as a springboard for a full launch of a Global Supply Chain Center in Paris, close to Charles de Gaulle Airport – one of the largest international logistics hubs in the World. This facility will also be just a 20-minute drive from the main European logistics center for our sister company, CRYOPDP. Our Supply Chain Center in Paris will be especially important for U.S. therapy developers that choose to conduct clinical trials in Europe. Our facilities in France will provide a gateway into Europe for drug products that need to be imported into a licensed facility and be released by a specific regulatory individual (known as a Qualified Person, or QP) before they can legally be administered to European patients.
However, our strategy for creating a global supply chain network will be a continual process driven by customer demand. We are already planning for more Global Supply Chain Centers in Southern California (to consolidate our Irvine facilities and to incorporate BioServices), the United Kingdom, and the Netherlands – and others will surely follow.
The growth of the cell and gene therapy industry is unprecedented, and we must grow at the same rate, or faster, to keep up with demand. Our future facilities will incorporate new technologies, automation, and streamlined operational processes to enable us to match the capacity and solutions demanded by our growing client base.
This is the start of a transformative process for Cryoport Systems – we are evolving and growing, just like the industry we are supporting. Exciting times ahead!!