Advanced Transformation

Digital transformation is a key phrase buzzing among modern pharma companies. Although there can be benefits for any enterprise, cell and gene therapy manufacturing is, arguably, where companies stand to gain the most. This area of the industry continues to mature and needs every edge it can get to optimize manufacturing. However, the digital journey is not an easy one, which is why many companies turn to partnerships. Here, we speak with software expert Alexander Seyf, CEO and co-founder of Autolomous, and David Smith, VP of Development at CDMO BioCentriq, to get their take on the digital future of the sector and tips for success in choosing the right technologies and partnerships. 

How can advanced digital platforms benefit manufacturers?
 

David Smith (DS): There are a number of points to highlight including reduced cost, faster response time, improved communication across stakeholders, robust chains of identity and custody, and improved efficiency and visibility on delivery times. Supply chain management interfacing digitally to the warehouse ensures stock levels are maintained based on usage – and even supplier stock levels. 

The difficult part is that these benefits are often not fully realized until organizations are fully digitized, where logistics is talking to warehousing, supply chain, operations, quality control and quality assurance – all the way up to management (and even to the patient). But even without full digital integration throughout, there are still wins to be made by dividing the entire vein-to-vein process into small bites and tackling individual focus areas to improve consistency and reduce costs. Introducing automation in certain areas, for example, can reduce the cost of labor by removing operators from manual, open processes. On the manufacturing floor, there can be a lack of communication between equipment and other departments. The ability to move data from a local instrument to a batch record electronically immediately opens up greater insight into how the manufacturing process is performing, where we stand in the manufacturing process, and the potential to predict what will happen next, such as maintenance requirements or long-term trends.

Alexander Seyf (AS): Digital platforms offer real-time monitoring for process control, automated data collection for ironclad audit trails, and insights that can help drive continuous improvement. These tools are essential for both efficiency and scalability. They should – and do – exist to revolutionize how partners book, manufacture, and deliver vein-to-vein cell and gene therapy treatments. 

What factors should companies consider when choosing the appropriate tech?
 

DS: The first point of call is to look at the critical quality attributes and critical process parameters of your product. Does the technology have the ability to provide a service within those limits? From there, a user requirement specification (URS) can be drawn to highlight the key requirements of the technology. It’s important that this URS be future-proof based on your needs. Is the technology needed for a pipeline of therapeutics or just one? The answer to this question can vastly change the URS. Also, when generating the URS make sure that someone with a GMP background has reviewed it. A 21CFR Part 11 compliant technology, for example, is not required in development but will be for GMP manufacturing.

Your URS should look specifically at the problem you are trying to solve. Remember: digitization is not the only answer to many problems faced by manufacturers today, indeed there are often far simpler, less time-extensive ventures that can be undertaken. Digitization can help, but it is important to not discount other options too early.

AS: Adopting digital solutions comes with a unique set of challenges. I advise manufacturers to prioritize flexibility and scalability, process optimization, automation potential, quality and regulatory rigor, and an open technology ecosystem. Also, look for a partner that will champion a partnership-first ethos across all endeavors – and one that will remain steadfast in their conviction that the full promise of cell and gene therapies is realized not in solitude but in unity. It is by forging strong partnerships that we will unlock the transformative power of cell and gene therapies. 

And what about when choosing a CDMO?
 

AS: For therapy developers at any stage, choosing a collaborative partnership with a CDMO is a pivotal decision. It’s not just about planning for success; it’s about being equipped to navigate the unforeseen. Choose a CDMO with a demonstrated track record in your therapy area. Look for strong process development capabilities to optimize your manufacturing and accelerate your path to market. You also want them to have a true understanding of the regulatory landscape to smooth the path to approval. 

A forward-thinking CDMO should either be capable of scaling with you to commercial production or have a reliable network to support your growth. If a CDMO can’t take you all the way to commercial scale, they should have an established network that can. The right CDMO convinces you to stay through unparalleled value, not through the inconvenience of change.

DS: The CDMO market today is stronger than ever in terms of available capacity, which used to be a key determining factor in who to choose. Now the gears have shifted, so too have CDMOs. Experience is my leading metric. A CDMO that has done it before can leverage their knowledge to keep things on track and succeed. But it’s not just about management, it’s also about the team on the ground, including material handlers, operators, quality control, and quality assurance. These are the personnel that will directly impact the success of your therapeutic, so visit them, ask them questions, and find out if they have the background to manufacture your therapeutic. Also, identify turnover rate and the likelihood of that team still being your team in nine months’ time. The role the therapeutic company can take in praising the team for successes is often overlooked. Making them feel part of the company can improve the success of a project. 

Beyond experience, flexibility and quality are crucial. During the process, the entire team will be learning about the therapeutic, so it’s vital to find a CDMO that can be flexible to your changing needs – not only for the services rendered, but also in how to communicate with your stakeholders. Ensure you visit the site and speak with the manufacturing team. Although flexibility is crucial, it has to be conducted within the confines of quality, so ensure the CDMO has the appropriate knowledge, documentation, and protocols to identify the rigidity of the quality system.

Autolomous and BioCentriq will be working together to streamline development and manufacturing using digital technologies. How will both companies benefit?
 

AS: True innovation cannot happen in isolation. Our partnership with BioCentriq will provide us with insights that will allow us to continuously refine our digital platform. This collaborative approach helps ensure that our platform remains fit-for-purpose and supports our partners as their requirements change.

With a focus on data capture, operational logistics, quality release by exception, instant tech transfer, and powerful data analytics, what we bring is a solid foundation upon which BioCentriq can operate. Capabilities such as automated batch release, integrated inventory management, patient support, and AI-driven insights align perfectly with BioCentriq’s vision for the future. We have a shared goal of making transformative therapies accessible to every patient in need.

DS: As a CDMO, we are keen to reduce the timeline and cost of technology transfers. We want to digitize a large proportion of the technology transfer process, starting with electronic batch records (eBR). Suppliers today provide eBR software to build records for use within GMP manufacturing. The aim of this work is to move the process upstream and into a development scenario, so building off executed protocols, data collection, and process knowledge that will already have been written in development. By creating protocol-based eBR for use in development, Autolomous can increase its market share by working with researchers as well as manufacturers in deploying their system. This move is crucial to help standardize processes and gain valuable insights into how manufacturing processes are developed. Armed with this information, the partnership will help provide knowledge and enhanced tools into the industry to increase patient access through improved manufacturing.

Give us a bold prediction of the near future of cell and gene therapies…
 

DS: Therapies are moving towards first-line treatment for larger indications. I expect this trend will continue with the need to manufacture more lots than ever before. This trend will once again put a constraint on manufacturing expertise, but can be offset with more automation and digital solutions.

AS: The future is where a fully automated, regulatory-compliant manufacturing and release process becomes a reality, ensuring that life-changing therapies can be delivered swiftly and safely. 

The future of CGT manufacturing is intrinsically linked to the industry’s ability to continually innovate, merging cutting-edge scientific research with the latest technological advancements. By proactively aligning scientific endeavors with emerging technologies, we can enhance the precision, efficiency, and scalability of therapies. This commitment to innovation ensures that, as we move forward, our journey is illuminated by the brightest minds and the most advanced tools at our disposal, driving the evolution of therapies that can transform lives.