Digitization – 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.

Strategies to increase cell therapy manufacturing capabilities

Simon Ng — Mon, 28 Feb 2022 17:56:22 +0000

Shannon Eaker, PhD, Cytiva, Marlborough, MA, describes important considerations when aiming to expand the capabilities of cell therapy manufacturers, including the need to increase recruitment and training of highly skilled workers as well as retaining existing workers. Dr Eaker additionally highlights constraints in the supply chain, and factoring in the scalability of a product in its design. The advent of automation and digitization in the form of electronic batch records will also aim to address the aforementioned issues by streamlining the manufacturing process. This interview took place at Advanced Therapies Week 2022.

Digitization in the advanced therapy sector

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

Shannon Eaker, PhD, Cytiva, Marlborough, MA, provides an overview of the significance of digitization in cell and gene therapy (CGT) manufacturing. Scaling up manufacturing remains a major barrier and digitization may be a solution to the issue. Whilst digitized standard operating procedures (SOPs) and batch records can streamline the manufacturing process, the low adoption rate due to the need for increased staff training requires to be addressed, especially when other stakeholders including regulatory authorities will digitize their records. The use of artificial intelligence (AI) can additionally enable efficient data collection and mining, which will be of particular use in the autologous setting. This interview took place at Advanced Therapies Week 2022.

Digitization in the CGT sector

Simon Ng — Tue, 15 Feb 2022 12:24:05 +0000

Arturo Araya, MBA, TrakCel, Cardiff, UK, discusses the increasing significance of digitization in the advanced therapies industry. The advent of a centralized tracking system has resulted in data from different suppliers relating to the product to be efficiently audited, especially by regulators to assess safety. Whilst digitization has enabled specialized organizations to fulfil particular tasks, the data needs to be properly tracked to be processed and privacy policies may restrict access to patients from a certain region. This interview took place at Advanced Therapies Week 2022.

Standardizing digitization processes in the CGT industry

Simon Ng — Mon, 14 Feb 2022 17:40:24 +0000

Kwok Pang, COO, Autolomous, London, UK, gives an overview of digitization tools in the cell and gene therapy (CGT) industry. The advent of process analytics within the field of digitization has enabled the exchange of data between different systems, and integration of various platforms has brought many advantages. He additionally highlights the value of an integrated value chain for GCT developers. This interview took place at Advanced Therapies Week 2022.

Building collaborative relationships to overcome challenges in the CGT industry

Simon Ng — Thu, 03 Feb 2022 12:25:11 +0000

Sharon Brownlow, PhD, Cell and Gene Therapy Catapult, London, UK, talks on the importance of collaborating between different stakeholders across academia, healthcare and industry in order to overcome barriers in the cell and gene therapy (CGT) space. Dr Brownlow comments on a consortium created by Cell and Gene Therapy Catapult to help maintain confidentiality, and supporting companies in their manufacturing process. Dr Brownlow additionally highlights the benefits of harnessing the power of pre-competitive collaboration. This interview took place at Advanced Therapies Week 2022.

Optimizing CGT manufacturing processes with digitalization

Simon Ng — Thu, 03 Feb 2022 10:27:38 +0000

Kwok Pang, COO, Autolomous, London, UK, discusses the relevance of the concept of Industry 4.0 within the cell and gene therapy (CGT) space, highlighting the advantages of process analytical technologies (PAT). To scale up manufacturing in the CGT industry, it is critical to understand the data in order to optimize manufacturing processes. However, many technologies in the CGT space have limited data exchange capabilities. PATs enable monitoring the data in real-time, which allows us to have a better understanding of the process. This interview took place at Advanced Therapies Week 2022.

Achieving operational excellence in CGT through automation

Simon Ng — Mon, 31 Jan 2022 17:59:03 +0000

Sharon Brownlow, PhD, Cell and Gene Therapy Catapult, London, UK, discusses the challenges in achieving operational excellence in the cell and gene therapy (CGT) field and strategies to overcome these challenges. Achieving operational excellence is necessary as the timeframe to release a product is very limited, but is challenging due to the highly complex process of manufacturing CGTs. Whilst automation will have a dramatic impact in improving operational excellence, many of the systems currently used in CGT are not tailored to early product development. Dr Brownlow additionally highlights how many companies are integrating processes together and developing more configurable systems, as well as ‘factory-in-a-box’ technologies which can manufacture multiple CGTs simultaneously in a fully automated fashion. This interview took place at Advanced Therapies Week 2022.

Novel technologies for the digitization of the advanced therapy supply chain

admin_vjr_user — Sat, 06 Nov 2021 09:39:19 +0000

Kwok Pang, COO, Autolomous, London, UK, describes a range of digital supply chain technologies being developed by Autolomous that aim to help advanced therapy manufacturers to scale their operations. For example, AutoloMATE Assist supports the batch verification and review process for advanced therapies to drive efficiency and accelerate the release of manufactured products to patients. In addition, AutoloMATE Clock aims to utilize technologies such as geofencing to help digitise the many aspects of manufacturing scheduling, including manufacturing operator resource management, equipment validation and clean room availability. This interview took place at the Advanced Therapies Congress & Expo 2021.