Supply Chain – VJRegenMed

OCELLOS: A novel advanced therapy orchestration platform

Simon Ng — Wed, 02 Mar 2022 11:58:16 +0000

Arturo Araya, MBA, TrakCel, Cardiff, UK, provides an overview of TrakCel’s OCELLOS platform and its role in the digitization of supply chain management. The cloud-based platform provides a scalable service that can be adaptable to different countries and their regulations and unlike a code-based system, OCELLOS provides the flexibility to respond to changes within the future via the partner MuleSoft platform. The modular nature of the platform additionally enables the system to be repaired more efficiently, as the whole platform does not need to be taken down for maintenance. He also highlights the potential integration of future technologies in OCELLOS, such as blockchain which may be utilized by healthcare systems. This interview took place at Advanced Therapies Week 2022.

How cell orchestration systems can assist advanced therapy developers

Simon Ng — Wed, 02 Mar 2022 11:58:15 +0000

Arturo Araya, MBA, TrakCel, Cardiff, UK, discusses the benefits of using cloud-based cell orchestration systems. For smaller companies, the use of such systems enables healthcare professionals and other relevant staff to efficiently carry out administrative tasks relating to patients in clinical trials, lowering the cost of conducing research. In the case of larger pharmaceuticals which may have multiple legacy systems in place, the use of cell orchestration systems enables all the legacy systems to be connected. This interview took place at Advanced Therapies Week 2022.

Patient-centric innovations in the supply chain

Simon Ng — Mon, 28 Feb 2022 17:56:21 +0000

Julia Tarasenko, MSc, Marken, Durham, NC, gives an overview of patient-centric approaches in improving the supply chain for advanced therapies, which usually cannot be administered at home. Long term storage of therapies will benefit patients who will need further doses and biobanking enables healthy cells to be retained if they are required for manufacturing new products. A decentralized approach is additionally required, especially for patients receiving chimeric antigen receptor (CAR) T-cell therapy, as they will benefit from long-term care from their own homes. This interview took place at Advanced Therapies Week 2022.

The effects of COVID-19 on the advanced therapy supply chain

Simon Ng — Mon, 28 Feb 2022 17:56:20 +0000

Julia Tarasenko, MSc, Marken, Durham, NC, comments on the impact of COVID-19 on the advanced therapy supply chain. Whilst the pandemic has caused great uncertainty within the sector, developers have had to consequently adapt to the changing circumstances and the supply chain has become more robust as a result. As people are now wary of potential setbacks, they are now more diligent in drawing up backup plans. This interview took place at Advanced Therapies Week 2022.

Differences in supply chains in the CGT industry

Simon Ng — Thu, 17 Feb 2022 12:05:00 +0000

Julia Tarasenko, MSc, Marken, Durham, NC, comments on the complexity of the supply chain in the cell and gene therapy (CGT) sector. Due to the nature of the products themselves, the manufacturing, storage and administration of these therapies require a supply chain more complicated than that of standard pharmaceutical products. She additionally emphasizes the need to create a robust supply chain, and adapt to the needs of patients who may have disease with limited treatment options. This interview took place at Advanced Therapies Week 2022.

The logistics of manufacturing allogeneic therapies on a large scale

Simon Ng — Thu, 17 Feb 2022 12:04:59 +0000

Julia Tarasenko, MSc, Marken, Durham, NC, discusses changes that are needed in the supply chain to adapt to an increasing demand in allogeneic therapies. Pivoting to a one-to-many supply chain is crucial to successfully manufacture allogeneic therapies on a larger scale, as well as focusing on local suppliers and storage, especially in the light of the COVID-19 pandemic. She additionally highlights the need to increase biobanking capabilities as the industry shifts to allogeneic therapies. This interview took place at Advanced Therapies Week 2022.

Novel supply chain changes in the advanced therapies space

Simon Ng — Thu, 17 Feb 2022 12:04:55 +0000

Julia Tarasenko, MSc, Marken, Durham, NC, describes recent trends in supply chains within the in the cell and gene therapy (CGT) industry. As COVID-19 has greatly disrupted the supply chain, just-in-time manufacturing has become more popular due to a dwindling supply of materials, and products can be produced in a matter of a few days from the procurement of the active pharmaceutical ingredient such as viral vectors. In spite of the pandemic, clinical trials are ongoing for advanced therapies, but the industry must consequently adapt to increased demand. This interview took place at Advanced Therapies Week 2022.

Addressing supply chain issues in clinical trials

Simon Ng — Tue, 15 Feb 2022 12:24:06 +0000

Arturo Araya, MBA, TrakCel, Cardiff, UK, describes challenges in supply chain management in the cell and gene therapy (CGT) sector. Due to the complexity of advanced therapies, there are multiple service providers contributing to each component of the product, resulting in a higher margin of error. A high cost of failure can also result in severe consequences if the therapy is administered to the wrong patient and manufacturing and supply chain capabilities can additionally be put under strain due to the sheer number of clinical trials occurring. This interview took place at Advanced Therapies Week 2022.

Supporting apheresis and manufacturing processes in the CGT space

Simon Ng — Mon, 07 Feb 2022 17:06:04 +0000

Delara Motlagh, PhD, MS, EMBA, Terumo Blood and Cell Technologies, Lakewood, CO, comments on the current activity of Terumo Blood and Cell Technologies within the cell and gene therapy (CGT) sector. The Spectra Optia system enables apheresis and cell collection from patients, an important process where a vast majority of advanced therapies begin with apheresis. Dr Motlagh additionally describes the Quantum Cell Expansion System, which provides a platform to scale-up cell expansion and modification in a sterile environment. This interview took place at Advanced Therapies Week 2022.

Regulatory challenges in automating CGT manufacturing

Simon Ng — Thu, 03 Feb 2022 10:27:41 +0000

Delara Motlagh, PhD, MS, EMBA, Terumo Blood and Cell Technologies, Lakewood, CO, discusses hurdles associated with automating processes within the cell and gene therapy (CGT) field. Despite collaborative efforts between manufacturers and regulatory authorities, supply chain issues persist. Dr Motlagh additionally highlights the need for companies to fully understand every aspect of their current and future products. This interview took place at Advanced Therapies Week 2022.