Automation & Digitisation
Cell Therapy
CMC
Gene Therapy
Regulatory & Standards
Supply Chain

Identifying Gaps in Vein-to-Vein Tracking and Supply Chain Digitisation

Phacilitate
19 October 2021
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In this Event Report, we explore the data and system gaps in clinical development and commercial therapies, as well as gaps and opportunities in processes, regulations and standards.

This second meeting of Working Group 2 included diverse experience in biotechs, data science, tech tools, manufacturing, academia, vein-to-vein processes, and more. Those present split into two groups to review gaps and opportunities across patient scheduling, apheresis, transport to manufacture, manufacturing, quality assurance & release, transport to clinic, and infusion.

Data and System Gaps in Clinical Development and Commercial Therapies

In their breakout meeting and summary, group one analysed data and system gaps in clinical development and commercial therapy.

Patient scheduling: Can we plan better around patient data and dependability? Patient data is rarely standardised and is commonly stored in disparate systems which are often paper-based.

Finding slots in hospitals and scheduling manufacturing is challenging and can be disrupted by outside variables such as extreme weather reports.

Apheresis: How do we address the number of systems involved? For documents, you need a source document for your COCCI. EMRs and forms are written differently, which causes problems when you compare them to source documents. While disparate custom systems can be effective, they still lead to gaps and inconsistencies at scale and between entities.

Transport to manufacture: What can we do to improve packaging? Varying packaging used by couriers and shipping providers can be problematic, along with complexity and variance in quality in packaging. An example of this is packaging that may or may not be pre-conditioned.

Couriers are an ongoing concern that must be addressed. Many companies aren’t medically trained, and services are often sub-contracted to general logistics providers who handle general goods. Temperature tracking in real-time is also lacking, which commonly risks expired samples.

Manufacturing: Can we improve forms for apheresis? There is an opportunity to streamline and standardise here; having information on markers ahead of time would be an improvement.

Slot management and long-term storage are challenging. In autologous therapy, apheresis is scheduled at the same time as manufacturing, but the patient can’t always come back at an ideal time. This is a storage difficulty and a data and system gap.

Standardisation between steps is also an issue; standards for system, sample, and integration are poor. Currently, the newness of tools makes integration difficult; middleware is often used, and configuration varies between customers.

In manufacturing itself, delays and terminations are heavily disruptive and hard to manage. Duplicated data entry is also a challenge for consistency, particularly where contract vendors are concerned.

QA & release: How do we address release criteria and deadbands? While these tend towards uniformity, it’s still a gap.

Understanding the state and progress of manufacturing, schedule shipment, and infusion dates is difficult. Tools, tech, and processes must come together to solve this. Right now, we’re always reactive.

Transport to clinic: Can we improve standardization in returned documents? Often, the level of detail provided or required in release criteria is inconsistent.

Similar issues exist here as do in the transport to manufacture stage: issues with weather, scheduling, system tracking, and courier experience and quality.

Infusion: Is there a better way to obtain data on success and challenges from patients? For infusion, measurements vary, and understanding lead times to drive continuous improvement is tough. We often must hunt down the information we need across disparate systems.

Systems: How do we handle standardisation software? It’s desired universally in some form, and everyone thinks they have the best solution! This makes it hard to weigh up options.

Finally, the financial reality of integration and standardisation varies. Opportunities exist for more efficiency and scalability. Right now, we have numerous systems including case management, orchestration, clinical, inventory management, and ERP.

Gaps and Opportunities in Processes, Regulations and Standards

With clinical development and commercial therapy covered, group two focused discussion on the analysis of gaps and opportunities in processes, regulations, and standards.

Patient scheduling: We must analyse the regulations and standards governing the flow of a patient journey. Upfront, scheduling and enrolment lack governing guidance. There are also differences between clinical and commercial, which varies from country to country and in how patient data collection is managed.

Apheresis: This is still a serious challenge we should address. Apheresis standardisation may be coming, but scientific reasons exist as to why companies take their own paths around this. What is being collected in data? We see lots of variation, such as in what manufacturers think they need to drive consistent manufacturing processes.

Transport to manufacture: Moving items across borders is a serious subject for us to review. There are varying GMO standards in Europe, and we think there should be more exceptions in material shipping for patients to help minimize barriers and delays, which pose a risk to both patients and material.

Manufacturing: We see gaps here around labelling and material standards, which also vary geographically. Courier systems are often offshoots that are subcontracted and come with their own data pieces, which allow for more gaps to occur.

QA & release: The group agrees there are gaps in quality procedures, serialisation requirements, and the need for Qualified Person (QP) releases in Europe, which complicates supply chains.

Products from America go to BMP manufacturing, where professionals check and pack items out into cryogenic storage before manually doing paperwork. This causes a delay of several days, which is often critical for patients.

Within hospitals, not much is defined and is often determined on a per-therapy basis. Sealing and managing material varies region by region and storage is an issue. Capabilities vary, which makes it hard for manufacturers to organise supply chains. Standards are taking hold to minimize the complexity present in some areas, but results so far are patchy.

The PDA is working on standardisation and is issuing papers and publications. These offer guidance on harmonising labelling, and it’s hoped that regulators pick these up and aid in implementation.

Transport back to clinic: The amount of information on autologous products, such as traceability numbers and barcodes, is a longstanding issue. Every vendor has its own system and identifier numbers vary. It’s hoped that new labelling standards such as ISBT 128 will address this.

Infusion: Standards exist in America for single portal access scheduling via a centralised repository for serialised products. Every country will approach this differently. In Europe, for example, tamper-evident seals are required. Many entities need access to information to trace back such as identify cell price, return dates, and more.


This session was moderated by:

This session was hosted in partnership with AmerisourceBergen on Tuesday 14th September 2021.

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