OSP: Could you please share the historical past of the Marken GMP community – when was it launched, storage/logistics capabilities there, the way it’s advanced through the years, and many others.
AVS: Marken has constructed and operated a completely GMP compliant owned community of 10 depots for the final decade, and these are additionally supplemented by choose accomplice depots in different key places all over the world. This community continues to develop with plans to open Los Angeles (USA) and Kiev (Ukraine) within the coming months.
Each depot is constructed after an in depth evaluation of consumer calls for in addition to geographical wants, permitting scientific trials to be carried out in a price environment friendly and optimized method. These central depots enable us to serve our purchasers with complete and environment friendly world distribution companies for his or her scientific drug merchandise and ancillary companies; they’re constructed to pharmaceutical manufacturing requirements and are absolutely GMP compliant.
Depots are normally co-located with our logistics hubs so as to take benefit of well-established customer support, operations import /export and administrative assist. Each of Marken’s depots are linked by the Solo platform, a worldwide state-of-the-art, 21 CFR half 11 validated, cloud-based stock administration system which might interface with IRT for improved stock reconciliation.
OSP: Could you please discuss in regards to the market circumstances and consumer wants that helped drive Marken’s determination to increase its frozen-room storage capabilities there? Was the corporate eyeing this chance earlier than COVID-19 hit?
AVS: The growth of cryogenic (liquid nitrogen) service places facilitates world cell and gene remedy trials. The mixture of our expanded places and packaging belongings permits Marken to satisfy consumer calls for in a quickly rising trade.
Ultra-low temperature transportation has develop into an more and more essential provide chain requirement for cell, gene or immunotherapy-based medicines and people plans had been in place nicely earlier than the pandemic. We proceed to see a rise within the demand for cell and gene remedy trial shipments.
We are dedicated to constructing the biggest cryogenic service community within the scientific logistics trade to securely join sufferers in all corners of the world with their required remedy.
OSP: In the announcement in regards to the Frankfurt facility, you discuss cell and gene therapies being a specific focus for Marken—might you present slightly extra element about how trade work on/curiosity on this space has advanced lately, and the way Marken is working to meet these related wants?
Ariette Van Strien, president, Marken
AVS: Advances in cell, gene and immunotherapy therapies proceed to develop at a speedy charge and the scientific trial provide chain is evolving to supply customized options for these life-changing therapies.
One of the more moderen modifications has been the event and concern of a brand new ISO normal that covers the transportation of cells for therapeutic use. Based on ISO9001, a panel of specialists from the trade and ISO requirements physique labored collectively to develop ISO21973, which was launched on the finish of June.
This new normal factors to the essential concerns for these concerned on this delicate and important work. Marken subject material specialists supplied experience early within the growth of the brand new normal, with the final word objective to attenuate variation, enhance reporting and communications, and to realize higher high quality of companies for purchasers and sufferers.
Marken’s expanded cryogenic community of liquid nitrogen service places and specialised fleet of packaging, permits our purchasers to recruit and deal with sufferers from a higher quantity of international locations all over the world. Six Marken branches grew to become Cell and Gene Centers of Excellence in 2019; as well as, a full-time, world workforce was appointed to develop and assist the services required to deal with cell, gene and immunotherapy supplies and merchandise.
The services have been designed to guarantee high quality, chain of id, information privateness and embody a mixture of greatest at school know-how, services, processes and measurements. A central management heart is now established at our headquarters in North Carolina; this workforce contains venture administration specialists, know-how SMEs and logistics operations workers who’re devoted to cell and gene companies on a full-time foundation.
As an essential half of many cell, gene and immunotherapies, cryogenic transportation at -150 levels C are supported by Marken’s liquid nitrogen delivery fleet, that are serviced at 14 geographically distributed places. Marken has been chosen as a key supplier for world cell and gene trials and business provide shipments all over the world.
OSP: Could you discuss how the COVID-19 pandemic has impacted Marken’s choices within the scientific trial provide chain service realm? Please be at liberty to speak about choices usually, in addition to this facility in particular. I like 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 talk) is fascinating on your purchasers, and methods through which your organization helps make that occur?
AVS: COVID-19 has impacted Marken in some ways together with how we onboard purchasers, growth of the quantity of international locations through which we had been capable of present direct-to-patient (DTP) companies, higher deployment of single use packaging, and a myriad of different evolutions in our each day enterprise.
For occasion, working carefully with our purchasers, we now have onboarded DTP trials in as little as just a few days, versus a extra typical timeline of a number of weeks. Our groups have labored collectively to rapidly procure and coordinate the suitable temperature-controlled packaging options and temperature displays into all international locations.
We shifted our forecasting so as to add in additional single use packaging reasonably than reusable as a result of of quarantining insurance policies in lots of areas and to assist guarantee the security of our workforce members and purchasers. We procured PPE tools for our branches globally and ensured sufficient provides for all of our drivers and employees. We adjusted our Standard Operating Procedures (SOPs) together with DTP driver No Touch protocols and processes to safeguard everybody concerned to satisfy the excessive demand to ship therapies to 1000’s of sufferers in want.
Risk mitigation is a multi-step course of and requires planning, foresight, know-how, and expertise. Reducing the quantity of handoffs eliminates potential weak factors within the provide chain, which advantages purchasers as a result of it implies that their vital and excessive worth shipments of drugs or remedy attain the affected person.
Through a long time of expertise, Marken’s workforce of specialists can critically assess any delivery lane and instantly establish factors of potential threat. Mitigation steps could be taken early on to keep away from as many potential pitfalls as potential. Communication is vital, amongst our groups and to our purchasers, to make sure success.
When scientific websites and hospitals wanted to refocus on COVID-related therapies and testing, Marken was prepared with companies that allowed sufferers to proceed with their trials by residence visits. Direct to/from Patient (DTP/DFP) and residential healthcare (HHC) companies present options to maintain scientific trials going, whereas sustaining affected person security, by delivery therapies on to participant’s houses.
Through DFP companies, organic samples could be retrieved from a affected person’s residence and despatched to laboratories for testing. Combining DTP companies with HHC companies permits sufferers to respect the confinement tips of their location whereas persevering with to take part of their scientific trial.
Prior to the pandemic, Marken was working DTP in 57 international locations. Now, that service has been supplied in over 80 international locations.
After sponsors safe permission to incorporate DTP companies into their protocols, Marken efficiently coordinates logistics and supply of 1000’s of scientific drug merchandise on to sufferers collaborating in trials all through Asia, Europe, the US and Latin America. All Marken workers and chosen companions are educated to supply DTP companies after the personnel carry out cautious threat assessments to make sure time and temperature management might be maintained for every cargo.
Further, Marken is including chilly cupboard space throughout our GMP community for vaccine storage. We have already procured an extra provide of -80C freezers with the choice to double the amount as wanted.
Early on, we assessed our availability for +2C to +8C and -20C storage wants so as to be prepared for vaccine storage and are additionally within the feasibility stage of including additional capacity inside Marken and the usfully owned GMP community. We are additionally carefully working with our sister firm, Polar Speed, a UPS subsidiary, to construct out a big chilly chain storage hub within the UK.
OSP: I perceive you may have extra services deliberate in varied components of the world—are you able to share any extra element about that?
AVS: In addition to the GMP-compliant services being added in Los Angeles, California and a brand new GMP-compliant depot in Kiev, Ukraine, two GDP-compliant logistics branches might be added in Dublin, Ireland and Amsterdam, the Netherlands. These latest additions to Marken’s world community add elevated capacity and allows Marken to proceed to supply superior provide chain companies to its purchasers, their investigator websites and sufferers.
The Amsterdam facility will embody a cryogenic filling station to satisfy the rising want of Marken’s cell and gene remedy purchasers. An extra LN2 service station has been added to Marken’s community in Geneva, Switzerland.