Reg Med - Aktuellt

Klustret i North Carolina,USA har haft ett framgångsrikt 2024. Man växer så det knakar och alltfler aktörer väljer att ansluta sig dit. Bloggens läsare har fått ta del av det i tidigare inlägg som ex här och här, men nu får vi det klätt i siffror.

NSF Piedmont Triad RegenMed EngineNSF Piedmont Triad RegenMed Engin251 följare18 tim • 18 timmar sedan

👉 NSF-PTRME Fuels $266 Million Investment: A Catalyst for American Innovation - In just one year, the NSF Piedmont Triad RegenMed Engine (PTRME) has achieved a transformative milestone—attracting over $266 million in private, philanthropic, and government investment. This represents an impressive 18X return on the initial $15 million NSF grant awarded in January 2024.

This momentum is creating a flywheel effect, establishing the NC Carolina Core as a unique regenerative medicine global nexus.  Recent highlights include:

✅ ProKidney Corp.’s $22.5M Expansion in Winston-Salem to advance regenerative technologies for renal failure.
✅ Gilero, A Sanner Group Company’s New Facility in Greensboro, focusing on state-of-the-art medical devices.
✅ Nelipak Healthcare Packaging’s Launch of its first North American specialty packaging operation in Winston-Salem.

By fostering collaboration among industry leaders and investing in local talent, the NSF-PTRME is strengthening American manufacturing, enhancing its competitiveness, and positioning itself as a global leader in the rapidly growing field of regenerative medicine.

🔗 The NSF-PTRME isn’t just growing a region; it’s strengthening America’s global competitiveness. Learn more: https://lnkd.in/eYhbBdEx
hashtag#Innovation hashtag#Investment hashtag#RegenerativeMedicine hashtag#EconomicGrowth

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På närmare håll kan berättas att vår granne Norge sent omsider bestämt sig för att även de vill vara med om den snabba utvecklingen som sker just nu inom området. Man satsar 50 Milj norska riksdaler för att bygga egen infrastruktur kopplat till befintlig Reg Med FoU. Närmar bestämt ett större kontrolllabb med uppgift att tillverka,verifiera,kontrollera och administrera Reg Med produkter till patienter. En funktion man inte haft tidigare utan fått använda sig av labb utrikes från.

NOK 50 million to establish a new ATMP infrastructure

A new grant will speed up the manufacturing of new cell therapies for personalised medicine in Norway. 16 Dec 2024

The Research Council of Norway has recently granted NOK 50 million to the Oslo University Hospital (OUH), in partnership with the University of Oslo and the Haukeland University Hospital (HUH) for the development and distribution of ATMPs.

“ATMPs represent a powerful therapeutic modality perhaps best illustrated by the unprecedented clinical success of cancer immunotherapy and chimeric antigen receptor (CAR) T cell therapy for B cell malignancies and autoimmune diseases. A unique feature of ATMPs is the potential for long-term cure, where conventional therapies typically have temporary benefits,” explains Anna Pasetto, Director of the Center for Advanced Cell and Gene Therapy (ACT) at OUH.

Delivering cutting-edge therapies

The ACT centre, one of the nodes in ATMP Norway, offers support for all steps required to take a research idea to patient treatment. This includes regulatory support, access to laboratories for process development and manufacturing. Customers get access to trained personnel and state-of-the-art equipment to guide them through this critical bottleneck in translating novel concepts to the clinic.

Missing infrastructure

In Oslo, there is a process development facility, also known as a pre-GMP facility, which is essential to deliver cell therapies to patients. ATMP Norway will support the establishment of a similar laboratory at HUH.

“We have a strong infrastructure, but it's not yet complete. Through our analysis of how to improve ATMP manufacturing efficiency in Norway, we identified one critical missing link in the manufacturing chain: a dedicated, GMP-certified quality control facility,” explains Pasetto.

Manufacturing cell therapies require adherence to strict regulations to ensure product quality and safety. Additionally, specific assays must be conducted whenever genetically modified cells are infused into patients.

“At present, these tests are outsourced to commercial providers in other countries, resulting in significant costs, logistical challenges, and delays from shipping samples across Europe. Waiting weeks or even months for results is simply not sustainable,” comments Pasetto.

The quality control laboratory will be located in the John Ugelstad Building, which is an extension of the existing Oslo Cancer Cluster Innovation Park. Photo: Sofia Linden

Quality control facility

Filling this gap, the funds from the Norwegian Research Council will be used primarily to build a national quality control laboratory, with rooms and equipment that can handle samples from all of Norway, including systems for storage, quarantine and tracking.

“We will also explore how to increase manufacturing capacity through adjusting laboratories for implementation of more automated processes. This is a very exciting development in the field with emergence of robotized systems that seamlessly connect devices through the manufacturing process,” Pasetto continues.

Expansion of Oslo Cancer Cluster

As a fortunate circumstance, Oslo Cancer Cluster is expanding with The John Ugelstad Building on the existing Innovation Park next door to the Radium Hospital, with the largest functioning GMP facility in Norway.

“This allowed us to custom design the new laboratory to meet all the requirements,” says Pasetto.

Thermo Fisher Scientific, one provider of technical solutions for ATMP, will also move into the new building section with four floors of labs and offices. The global biotech company has strong Norwegian roots since their acquisition of the Norwegian company Dynal and its product Dynabeads, which are used in CAR T cell therapies spearheading the clinical implementation of ATMPs.

“With the presence of Thermo Fisher and other companies in the Incubator, we foster a highly beneficial environment where all the scientists are exceptional, deeply motivated, and fully understand the urgency of our work,” says Pasetto.

Min kommentar

Här känns det som att PHI med HoloMonitor har en given plats. Med den avsaknad av ett labb med uppgift att sköta kontroll och kvalitetsgranskning av Reg Med produkter kommer nu Norge strax ha det på plats. 

Är PHI på fötter och snabba i vändningarna bör de ha en god chans att få in HoloMonitor-instrument i den utrustning som kommer upphandlas när bygget står klart. 

VD-Anders kan här fixa sin första PHI-triumf (försäljning) med lite flax. Bloggen håller tummarna.

                                               Mvh the99