By increasing the size of its Frankfurt, Germany, facility (slated to go online in October) to more than 40,000 square feet, Marken is increasing its frozen-room storage capabilities and accommodating more clients looking to transport and store cell and gene therapy solutions. Outsourcing-Pharma (OSP) recently spoke with Marken president Ariette van Strien (AVS) about the GMP-certified facility, the industry’s evolving cold-storage demands and how COVID-19 is impacting the business.
OSP: Could you please share the history of the Marken GMP network – when was it launched, storage/logistics capabilities there, how it’s evolved over the years, etc.
AVS: Marken has built and operated a fully GMP compliant owned network of 10 depots for the last decade, and these are also supplemented by select partner depots in other key locations around the world. This network continues to grow with plans to open Los Angeles (USA) and Kiev (Ukraine) in the coming months.
Each depot is built after an extensive analysis of client demands as well as geographical needs, allowing clinical trials to be conducted in a cost efficient and optimized manner. These central depots allow us to serve our clients with comprehensive and efficient global distribution services for their clinical drug products and ancillary services; they are built to pharmaceutical manufacturing standards and are fully GMP compliant.
Depots are usually co-located with our logistics hubs in order to take advantage of well-established customer service, operations import /export and administrative support. Each of Marken’s depots are connected through the Solo platform, a global state-of-the-art, 21 CFR part 11 validated, cloud-based inventory management system which can interface with IRT for improved inventory reconciliation.
OSP: Could you please talk about the market conditions and client needs that helped drive Marken’s decision to expand its frozen-room storage capabilities there? Was the company eyeing this opportunity before COVID-19 hit?
AVS: The expansion of cryogenic (liquid nitrogen) service locations facilitates global cell and gene therapy trials. The combination of our expanded locations and packaging assets allows Marken to meet client demands in a rapidly growing industry.
Ultra-low temperature transportation has become an increasingly important supply chain requirement for cell, gene or immunotherapy-based medicines and those plans were in place well before the pandemic. We continue to see an increase in the demand for cell and gene therapy trial shipments.
We are committed to building the largest cryogenic service network in the clinical logistics industry to safely connect patients in all corners of the world with their required therapy.
OSP: In the announcement about the Frankfurt facility, you talk about cell and gene therapies being a particular focus for Marken—could you provide a little more detail about how industry work on/interest in this area has evolved in recent years, and how Marken is working to fulfill these associated needs?
AVS: Advances in cell, gene and immunotherapy therapies continue to grow at a rapid rate and the clinical trial supply chain is evolving to provide personalized solutions for these life-changing therapies.
One of the more recent changes has been the development and issue of a new ISO standard that covers the transportation of cells for therapeutic use. Based on ISO9001, a panel of experts from the industry and ISO standards body worked together to develop ISO21973, which was released at the end of June.
This new standard points to the important considerations for those involved in this sensitive and essential work. Marken subject matter experts provided expertise early in the development of the new standard, with the ultimate goal to minimize variation, improve reporting and communications, and to achieve better quality of services for clients and patients.
Marken’s expanded cryogenic network of liquid nitrogen service locations and specialized fleet of packaging, allows our clients to recruit and treat patients from a greater number of countries around the world. Six Marken branches became Cell and Gene Centers of Excellence in 2019; in addition, a full-time, global team was appointed to develop and support the products and services required to handle cell, gene and immunotherapy materials and products.
The products and services have been designed to assure quality, chain of identity, data privacy and include a combination of best in class technology, facilities, processes and measurements. A central control center is now established at our headquarters in North Carolina; this team includes project management specialists, technology SMEs and logistics operations staff who are dedicated to cell and gene services on a full-time basis.
As an important part of many cell, gene and immunotherapies, cryogenic transportation at -150 degrees C are supported by Marken’s liquid nitrogen shipping fleet, which are serviced at 14 geographically distributed locations. Marken has been chosen as a key provider for global cell and gene trials and commercial supply shipments around the world.
OSP: Could you talk about how the COVID-19 pandemic has impacted Marken’s offerings in the clinical trial supply chain service realm? Please feel free to talk about offerings in general, as well as this facility in specific. I love this straight-forward quote: “Fewer handoffs mean fewer variables, less risk and an unbroken chain of custody.” Could you please elaborate on why shortening the chain (so to speak) is desirable for your clients, and ways in which your company helps make that happen?
AVS: COVID-19 has impacted Marken in many ways including how we onboard clients, expansion of the number of countries in which we were able to provide direct-to-patient (DTP) services, greater deployment of single use packaging, and a myriad of other evolutions in our day to day business.
For instance, working closely with our clients, we have onboarded DTP trials in as little as a few days, as opposed to a more typical timeline of several weeks. Our teams have worked together to quickly procure and coordinate the appropriate temperature-controlled packaging solutions and temperature monitors into all countries.
We shifted our forecasting to add in more single use packaging rather than reusable because of quarantining policies in many areas and to help ensure the safety of our team members and clients. We procured PPE equipment for our branches globally and ensured adequate supplies for all of our drivers and workers. We adjusted our Standard Operating Procedures (SOPs) including DTP driver No Touch protocols and processes to safeguard everyone involved to meet the high demand to deliver treatments to thousands of patients in need.
Risk mitigation is a multi-step process and requires planning, foresight, technology, and experience. Reducing the number of handoffs eliminates potential weak points in the supply chain, which benefits clients because it means that their critical and high value shipments of medicine or treatment reach the patient.
Through decades of experience, Marken's team of experts can critically assess any shipping lane and immediately identify points of potential risk. Mitigation steps can be taken early on to avoid as many potential pitfalls as possible. Communication is critical, amongst our teams and to our clients, to ensure success.
When clinical sites and hospitals needed to refocus on COVID-related treatments and testing, Marken was ready with services that allowed patients to continue with their trials through home visits. Direct to/from Patient (DTP/DFP) and home healthcare (HHC) services provide solutions to keep clinical trials going, while maintaining patient safety, by shipping treatments directly to participant’s homes.
Through DFP services, biological samples can be retrieved from a patient’s home and sent to laboratories for testing. Combining DTP services with HHC services allows patients to respect the confinement guidelines of their location while continuing to participate in their clinical trial.
Prior to the pandemic, Marken was operating DTP in 57 countries. Now, that service has been provided in over 80 countries.
After sponsors secure permission to include DTP services into their protocols, Marken successfully coordinates logistics and delivery of thousands of clinical drug products directly to patients participating in trials throughout Asia, Europe, the US and Latin America. All Marken staff and selected partners are trained to provide DTP services after the personnel perform careful risk assessments to ensure time and temperature control will be maintained for each shipment.
Further, Marken is adding cold storage space across our GMP network for vaccine storage. We have already procured an additional supply of -80C freezers with the option to double the volume as needed.
Early on, we assessed our availability for +2C to +8C and -20C storage needs in order to be ready for vaccine storage and are also in the feasibility stage of adding further capacity within Marken and the UPS fully owned GMP network. We are also closely working with our sister company, Polar Speed, a UPS subsidiary, to build out a large cold chain storage hub in the UK.
OSP: I understand you have additional facilities planned in various parts of the world—can you share any additional detail about that?
AVS: In addition to the GMP-compliant facilities being added in Los Angeles, California and a new GMP-compliant depot in Kiev, Ukraine, two GDP-compliant logistics branches will be added in Dublin, Ireland and Amsterdam, the Netherlands. These newest additions to Marken’s global network add increased capacity and enables Marken to continue to offer superior supply chain services to its clients, their investigator sites and patients.
The Amsterdam facility will include a cryogenic filling station to meet the growing need of Marken’s cell and gene therapy clients. An additional LN2 service station has been added to Marken’s network in Geneva, Switzerland.
