The Digital Transformation of CDMOs for Cell and Gene Therapies

Innovative Technologies The Digital Transformation of CDMOs for Cell and Gene Therapies

27.04.2023 Source: Ahlam Rais Reading Time: 6 min

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The rising demand of cell and gene therapies across the globe has forced life science, pharma companies and even research institutes to turn to Contract Development and Manufacturing Organizations (CDMOs) for developing and delivering treatments quickly to patients in need. Digital transformation is one area that is being explored by CDMOs to accelerate this pace.

Since cell and gene therapies are still evolving, require extensive resources and expertise for its development and manufacturing, life science, pharma companies and even research institutes are turning to CDMOs to help them out.
(Source: Anusorn - stock.adobe.com)

Cell and gene therapies (CGTs) are gaining prominence in the healthcare sector as there is an increasing need to treat patients with life threatening diseases such as cancer and other genetic diseases for which cures are not readily available in the market. In CGTs, cells can be taken from a patient’s body, be engineered with a new gene and infused back into the patient’s body to treat their illness or immune cells can also be upgraded to better detect and kill harmful cells.

According to a press release by market research firm Straits Research, the global cell and gene therapy market share was estimated to be worth 4.32 billion dollars in 2021 and is expected to reach 54.19 billion dollars by 2030, expanding at a CAGR of 32.45 % from 2021 to 2030. These figures showcase the accelerated growth of this segment.

The key role of CDMOs

Since CGTs are still evolving, require extensive resources, expertise for its development and manufacturing as well as a lot of coordination between the suppliers and manufacturers, life science, pharma companies and even research institutes are turning to Contract Development and Manufacturing Organizations to help them out, thus increasing the demand for them. Nonetheless, CDMOs also help these companies to lower production costs.

Automation and AI are trending

Contract Development and Manufacturing Organizations are also realizing that digital transformation is now crucial for business i.e. developing and delivering treatments quickly to patients in need. “Automation technologies and Artificial Intelligence (AI) in the Advanced Therapy Medicinal Products (ATMP) industry is an emerging trend and recognized as an absolute requirement,” says Yatindra Tirunagari, Head of Process Development from Rentschler ATMP, a leading global CDMO based in Germany. “They reduce user errors. With reduced errors comes increased confidence from regulatory authorities. Furthermore, automation and AI allow for the integration of disruptive technologies while maintaining compliance. This highlights the connection between compliance and the never-ending process of innovation. They both complement one another.”

Yatindra Tirunagari, Head of Process Development from Rentschler ATMP.
(Source: Rentschler ATMP)

He further mentions that automation and AI are also an important part of Quality by Design (QbD). The QbD approach in ATMP means integrating scientific knowledge and risk assessment into designing and building the product development life cycle. The benefit of this approach is the opportunity to implement manufacturing processes that have a pre-defined level of quality. This is a critical requirement for the licensing and marketing of any CGT product.

Tirunagari elaborates, “Automation and AI greatly impact the development of components according to chemistry, manufacturing, and controls (CMC) standards. Introducing AI and digital platforms allows fully digital data capture, providing insights for process characterization and effective root cause analysis. This reduces the time and cost of process development, and it seamlessly feeds into tech transfer and the CMC evidence required for regulatory approval.”

On the path to digital transformation

In this background, CDMOs are acquiring technology companies or building long-term partnerships with diverse technology developers to help them reach their goal. For instance, Lonza, one of the leading CDMOs in the world, acquired Moda Technology Partners, a software firm that specializes in paperless quality control solutions. The company introduced the Lonza Moda-ES solution, a Manufacturing Execution System (MES) which bridges the gap that currently exists between manufacturing and quality control to provide a single electronic batch record with an intuitive review and approval interface. The platform combines data capture and error prevention with the flexibility to capture and trend key quality and performance metrics, both in the lab and on the production floor, mentions the Lonza website.

Lonza has also collaborated with Trakcel, a renowned supplier of cellular orchestration solutions for clinical trials and commercial therapies to the CGT sector. Under this partnership, Trakcel’s cell orchestration platform Ocellos (a platform developed to facilitate the end-to-end journey of advanced therapies for both the clinical trial and commercial settings) and Lonza’s manufacturing Moda-ES platform will be combined. The merger is expected to ensure that critical manufacturing steps, checks and data flow directly into the Chain of Custody and Chain of Identity within the CGT supply chain, without the opportunity of being missed or not connecting with the patient journey, states a press release by Trakcel. It further adds that this will help developers gain additional visibility and control whilst reducing product loss, delayed treatment, recalls and poor-quality product.

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In addition to this, Charles River Laboratories International, a cell and gene therapy CDMO solutions provider, acquired the cell and gene therapy CDMO Cognate Bioservices in 2021. In the previous year, Cognate collaborated with L7 Informatics to deploy the L7 ESP (Enterprise Science Platform), a unified data and process automation platform covering manufacturing, quality control, clinical operations, and real-time process intelligence products powered by Microsoft PowerBI, and implement an integrated manufacturing and lab system. The platform offers an end-to-end solution for the regulatory compliant automation of ATMP manufacturing and quality control operations from original source samples to final Drug Products including the integration of bio-process equipment and quality control instruments, shares a release by L7 Informatics.

Tirunagari goes on to share that automation technologies and AI are also a key to advances in capsid engineering, which can improve drug safety and give us better clinical outcomes. AI can be used to select optimal capsids from large libraries based on safety data from clinics. Simulation models can be run to inform optimal selection, which means higher infectivity, which consequently allows for smaller batches and reduced COGs.

The Switzerland-based pharma company Novartis recently announced its decision to expand and strengthen its CDMO business. In 2020, the pharma firm entered into a partnership with Dyno Therapeutics, a biotechnology company that uses AI for gene therapy. Under the partnership, both the firms committed to work together to develop novel Adeno-Associated Virus (AAV) capsids, the cell-targeting protein shell of viral vectors, with improved functional properties for gene therapy, according to a press release by Dyno Therapeutics. Novartis will use its expertise in gene therapy development and global commercialization while Dyno’s will utilise its Capsidmap artificial intelligence platform to deliver innovative gene therapies to patients with serious diseases of the eye, mentions the release.

“Defining critical process parameters early in development will define the critical quality attributes of the process, which is a huge benefit of AI and automation. Well-chosen partnerships can be very helpful in the incorporation of these technologies, given that the required levels of specialized AI and bioinformatics expertise are quite high. By working with the right partners, these requirements can change from obstacles to advantages,” concludes Tirunagari.

CDMOs are leaving no stone unturned to make their mark in the cell and gene therapy industry as they know that digital transformation can change the dynamics for the sector and that this is just the beginning of a revolutionary change in healthcare.

Key takeaways on streamlining data management and analytics for CGT production

Yatindra Tirunagari, Head of Process Development from Rentschler ATMP shares the following points:

First make sure to reduce the process variability to a minimum so that the relation between Critical Process Parameters and Critical Quality Attributes are as clear as possible.

Choose wisely which data to collect and focus on meaningful data to make sure the collected data correlates to the Critical Quality Attributes in a direct or indirect way.

Move away from paper-based systems and aim to implement an integrated data management platform that automatically collects and centralizes data, assures data integrity and enforces appropriate regulation while being aware of the ongoing processes.

Algorithms for data analysis of which the internal working is interpretable by physical concepts and that guide a human operator to take better decisions in less time (instead of autonomously intervening in the process itself), will be normal in the foreseeable future.

Improves monitoring, control and optimization of the production process.

Faster (and potentially real-time and on-line) assessment of release criteria and potency testing

Cost of goods reduction through automation and efficiency gains in the manufacturing process

More effective scaling of manufacturing since changes in Critical Quality Attributes are understood earlier in the development process.

Improved quality assurance

Reduction of administrative workload through automated traceability and audit trails

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