Empowering Biotech Innovations Through Automation: A Guide to Strategy Development & Implementation

Co-authored by Cory Proctor, Sr. Director, and Nicholas Weinreich, Sr. Manager

In biotech, automation and digitization are now essential in drug production. But with so many automation options, creating a strategy that fits your company's unique needs can be tough. This guide aims to provide a comprehensive method for designing and implementing an effective and tailored automation strategy.

Automation Systems

When developing an automation strategy, it’s essential to pinpoint specific areas where automation can optimize control, monitoring, data management, and reporting. By thoroughly assessing these areas, manufacturers can effectively leverage automation to streamline operations, enhance data accuracy, and boost overall efficiency.

Focusing on key opportunities for automation improves process control and operational performance while maintaining data integrity. Partnering with experienced automation experts ensures that companies create strategies tailored to their unique needs, achieving both regulatory compliance and a competitive edge in the fast-evolving biotech landscape.

Considerations for Defining an Automation Strategy

Automation has become an integral part of manufacturing, enabling companies to enhance efficiency, accuracy, and compliance in their processes. However, developing an effective automation strategy requires careful consideration of the company’s current phase as well as the specific requirements of their products. In today’s competitive landscape, companies are increasingly turning to automation solutions to optimize their manufacturing processes. Phase-appropriate investments and an understanding of speed to market, cost-cutting, process definition, and validation play crucial roles in shaping a company’s automation strategy.

A well-designed automation strategy, driven by a deep understanding of Part 11 requirements, not only helps developers streamline their processes but also enhances quality, traceability, and overall efficiency. By partnering with automation experts well-versed in the nuances of manufacturing, companies can navigate the complexities of Part 11 compliance and create a future-ready automation strategy that aligns with their unique needs and regulatory obligations.

Embracing the Therapeutic Revolution: Developing a Flexible Automation Strategy

The biotech industry is experiencing a therapeutic revolution, marked by rapidly evolving market conditions and technological advancements. This dynamic landscape poses unique challenges for manufacturers, requiring them to adapt their automation strategies to keep pace with innovation. It is therefore critical to develop a flexible approach that can seamlessly integrate emerging technologies while minimizing the impact of system changes and validation efforts.

A flexible automation strategy should be able to accommodate future technological upgrades and seamlessly integrate new systems and equipment. By considering modularity, scalability, and interoperability in the design phase, manufacturers can ensure that their automation solutions are adaptable and future-proof. To take full advantage of new technologies, it is essential to minimize change impact to existing or planned engineering and validation efforts.

Employing standardization and harmonization principles in automation design helps minimize the impact of changes. Industry best practices help manufacturers ensure compatibility and interoperability between different systems and processes. Which, in turn, simplifies the integration of new technologies and facilitates efficient engineering and validation activities. This approach not only enables manufacturers to stay competitive but also enhances agility, efficiency, and product quality.

Balancing Current Automation Needs with Future Circumstance

It is crucial to consider both the current circumstances of the company and its future goals of the facility. The automation strategy should provide a solid foundation that accommodates the existing manufacturing processes while also being adaptable to future expansions, changes, or advancements.

The first step is assessing the ideal level of automation for the manufacturing process. This involves evaluating various factors such as process complexity, product volume, regulatory requirements, and operational efficiency. Several automation options exist, including islands of automation, centralized batch reporting, and electronic batch records, each offering unique advantages and challenges.

Assessing Future Facility Needs and Purpose

In addition to assessing the ideal level of automation, it is essential to consider the future purpose of the facility when defining the strategy. This includes evaluating factors such as the potential for a single process or multiple/changing processes, additional laboratories, or future expansions.

For a facility focusing on a single process, the automation strategy should be designed to optimize and streamline that specific process. It should incorporate automation solutions tailored to the unique requirements of that process, ensuring efficiency, quality, and regulatory compliance. In contrast, facilities with multiple or changing processes require a more flexible automation strategy. Such strategies should accommodate the diverse needs of different processes, allowing for seamless transitions, equipment reconfigurations, and data integration. A modular automation approach can facilitate the integration and scalability of new processes, accommodating future expansions or changes.

To create an initial automation strategy that encompasses the company’s current circumstances and future goals, the following steps should be taken:

By following these steps, companies can establish a strong foundation for automation that not only enhances current operations but also remains adaptable to future needs and growth.

Comparing Islands of Automation vs Centrally Controlled Facilities

When developing an automation strategy, companies must decide between adopting islands of automation or a centrally controlled facility. Each approach has distinct advantages and considerations. A clear understanding of the ideal use cases, benefits, and limitations of both models is key to making an informed decision that aligns with a company’s operational needs and long-term goals.

Islands of Automation

Islands of automation involve leveraging original equipment manufacturer (OEM) automation solutions for control, monitoring, and reporting allowing for targeted optimization and control. Under this strategy, each system operates independently, with its own controls, recipes, and reports.

Centrally Controlled Facilities

Centrally controlled facilities rely on a central control system or process control system for comprehensive control, monitoring, and reporting of the entire manufacturing process.

Combining Strategies for a Hybrid Approach

Companies may also combine different strategies to create a hybrid approach tailored to their specific needs. Understanding how a hybrid approach could be integrated can optimize their automation investments and achieve synergy in their manufacturing processes.

Whichever you choose, collaboration with automation experts and thorough testing is key to a smooth implementation. Ensure seamless operation of the combined automation solution by prioritizing thorough documentation, testing, and validation processes.

About Project Farma

Project Farma, a Precision for Medicine company, specializes in providing comprehensive biomanufacturing strategies and execution services. We have successfully industrialized over 10 commercial cell, gene, and novel therapies, executed 60+ facility builds and capital expansions, and managed $6B+ in technical operations capital investments.

With expertise spanning startups, leading life science corporations, advanced therapy organizations, universities, hospitals, government agencies, and more, our team delivers proven technical operations and manufacturing solutions that shorten time-to-market, helping patients in need.

Visit our website to learn more about Project Farma and how Precision for Medicine’s integrated capabilities—across labs, clinical trials, manufacturing, and data intelligence—can help your organization bring therapies to life.