Digitizing advanced cell and gene therapies supply chains for scale

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Creating the perfect blueprint for cell & gene supply chain

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Learn how supply chains in pharmaceutical industry can leverage the best of technologies and make cell therapy affordable for a mass commercialization.    

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Learn how pharma companies can build an infinitely scalable cell & gene supply chain for a globalized market

 

 

Designing a Systematic and Industrialized Cell & Gene Supply Chain

We are entering the next generation of drugs and medicine. With the advanced cell and gene therapy, drugs have become highly complex and have completely changed the scope of what can be treated. The rate of progress is dramatically fast… but are the supply chains fully capable of adapting to a highly dynamic and variable cell therapy scenario? I think not, not yet.

With our inclination towards autologous cell and gene therapies, pharmaceutical companies are, for sure, acknowledging the major shift in regular supply chains… i.e., the inclusion of the patient itself! But this acknowledgment is not being matched with a full-scale re-design, that accounts for every factor involved in an ideal ‘vein-to-vein’ supply chain. There are lots of friction points that are holding us back in commercializing it.

Friction points that are holding us back

1. Single source of raw materials

The supply chain in pharmaceutical industry is not very flexible. From reagents to equipment, a huge proportion of the materials involved in the process are procured from a single supplier. This is a major reason for the disruptions of the supply chains as it involves complete dependability on a single supplier. 

2. Inefficient handling of Chain of Identity (COI) & Chain of Custody (COC)

The CAR T cell therapies come with a lot of intricacies that need to be dealt with accurately. The patient’s safety and product quality depend on the proper tracking of the T cells and making the entire COI/COC process scalable. Existing software systems are mostly standalone systems that are not modular enough for a patient-to-patient basis. This creates a lot of restraints in scaling and adaptability,  making information technology in supply chain management really cumbersome.

3. Shortcomings in cold-storage

Raw material and final drugs in advanced cell therapies are ultra-sensitive to temperature changes. The entire logistic and delivery chain needs to be monitored at all times for optimum temperatures, which is missing in today’s supply chains.

These friction points are not just mere catalysts for disruptions; they are the root causes of exacerbating problems and life-threatening situations. Fully personalized cell therapy will only see a viable future in mass commercialization if supply chains are re-thought and re-designed completely. 

The vision for industrializing the cell and gene supply chain

Advanced cell and gene therapy has been a revolution for us. And that means the supply chain digitization will have to be another industrial revolution, which involves leveraging the best of technologies and utilizing the most effective resources. 

The key to establishing versatile supply chains is shifting the manufacturing paradigm away from a Fordist type system to a decentralized system. Only this will enable a dynamic ecosystem that comes with infinite scalability and limitless configurability. 

Key innovations for future supply chains

1. Technologies to be leveraged 

Automation:

Autologous cell therapies come with a lot of risks in terms of variability and timing. Using Automation technologies like Robotic Process Automation (RPAs) and Machine Learning can eliminate the risk of human error and maintain consistency across the chain. Other benefits include;

• Scalability: Keep adding tools and instruments instead of new staff

• Reduced labor resources: Freeing up manpower

• Reduced need for expert staff: Training machines instead of people

An expert automation solutions provider and integrator, like Suyati, can help pharmaceutical companies set up custom-tailored automation environments. It can also help in integrating legacy systems and platforms into the new automation framework. 

Enterprise-grade Software:

Information technology in supply chain management is a core aspect.  Creating a safe and efficient COI/COC process requires enterprise-grade applications that are capable of processing large volumes of information at once.

Cloud-based infrastructure:

A cloud-based administrative infrastructure can be used to go beyond the traditional standards and set up decentralized supply chains for a patient-to-patient basis, and configure them as per the evolving cell therapy landscape. 

Internet of Things (IoT):

This is a critical technology to be leveraged in supply chain digitization. IoT tech allows for remote processing of data collected from various types of Bluetooth and internet sensors. This enables a fully-controlled logistics chain where temperatures can be monitored and controlled remotely. 

2. Becoming fully Interoperable

Using Blockchain Technology:

During the entire course of a vein-to-vein supply chain, various relationships are developed between suppliers, practitioners, researchers, and companies. To establish private online communities for enhanced exchange of resources and data, Blockchain technology can be leveraged for;

• Creating a virtual ledger: All digital data generated from transportation, manufacturing, and transactions can be easily accessed by all members using a decentralized digital ledger. This is an important aspect for supply chain digitization.

• Implementing serialization: A complete serialization can be implemented at the unit and item level, which, in conjunction with other data, provides a unique code for every product and patient.

• Implementing security: A completely secure community can be established where no information can be forged or manipulated in any way.

Building key partnerships:

We live in a globalized market where patients and manufacturing units are, many times, not present in the same region. This involves building global pharma supply chains that are free of any disruptions from procurement issues, clearance issues, or shipment issues.

• Partnering with peer organizations: Pharmaceutical companies can partner up with various peer organizations that can help them provide all the materials, reagents, and equipment in time, in case the primary supplier is unable.

• Partnering with compliance agencies: Building partnerships with customs agencies can enable a company to have pre-clearance capabilities worldwide so that time-sensitive shipments are not delayed by international borders.

• Partnering with review boards: Pharma companies can partner with review boards to help them review all the interim plans and results achieved, before looping in the patient and starting the drug manufacturing process. This allows for preplanning which, in turn, protects the patient.

Perfecting cell therapy designs with operational simulations

Regenerative medicine holds great hopes for stem cell development. The ability of stem cells to take up the functional roles of a specialized cell is immensely helpful in advancing cell therapy. 

A cell's identity is driven by which DNA is read or not read at one particular point in time. The signaling in the cell, to start or stop reading DNA, happens through proteins called transcription factors. This Identity undergoes many natural changes during development as cells transition from an undesignated cell to a specific cell type. One of the main proteins involved in stem cell generation is a transcription factor called Oct4. It induces the gene expression of the proteins that reset the adult cell into a stem cell. 

Computer simulations can depict how a pioneer transcription factor binds to nucleosomes to open chromatin and regulate gene expression. This is a great breakthrough in stem cell research, as more computer simulations can help us in identifying bottlenecks and visualize how DNA converts adult cells into stem cells. This creates a massive opportunity to pioneer transcription factors for efficient and reliable production of stem cells and other cells needed in regenerative medicine. 

If you're looking for an expert automation solutions provider that is well-versed with the latest pharmaceutical supply chain products, you can contact Suyati. Suyati is a pioneer in implementing cutting-edge automation solutions, offering both standalone and integrated solution packages. Visit Suyati to learn more about their offerings.