In this episode of Exceeding Your Benchmark, changes in drug delivery resulting from combining highly potent APIs and monoclonal antibodies into antibody drug conjugates (ADCs) are discussed as examples when considering how to pivot pharmaceutical manufacturing facilities. Lead process engineer at CRB, Ashley Harp, outlines the advance in synthesis and technology, making this shift possible. She emphasizes the need for a balance between containment and cleaning and the difficulty of testing products when rapid innovation is occurring. Manufacturing capacity is also discussed, drawing attention to the need for more specialized facilities and an understanding of outsourcing to CDMOs. Discussion of tight regulations ensure continued advancements while complying with accepted guidelines.
How Life Science Manufacturers Can Successfully Adapt to Change
Rapid innovation leads to challenges
Rapid innovation has led to a number of new changes in the manufacturing industry, such as the emergence of antibody drug conjugates (ADCs). These changes have allowed companies to provide targeted therapies and increase the therapeutic window by delivering drugs directly to target cells. Ashley Harp, lead process engineer at CRB, explains that these changes have created a number of challenges for companies to adapt to.
One challenge is the need for a balance between containment, cleaning and aseptic design. In the past, equipment and facilities were designed for either aseptic manufacturing or for containment and personnel protection, but recent advances have allowed for both product protection and personnel protection to be achieved. Additionally, there is a need for new test methods to allow for after cleaning to test for the presence or absence of new chemicals.
Another challenge is the lack of adequate manufacturing capacity. Facilities that have been designed for high speed, high throughput production are still focused on COVID-related products, meaning that new facilities need to be designed for the right products. This has led to an increased reliance on CMOs and CDMOs to fill the gap, but many people are not comfortable with this shift from large pharma manufacturing to outsourcing.
Finally, rapid development leads to a lag in regulatory guidance and requirements. This means that it is essential for companies to work closely with regulatory agencies and SMEs to ensure that they are meeting industry standards and expectations with rapid innovation.
Overall, rapid innovation has created a number of challenges for companies to adapt to. The need for a balance between containment and cleaning, the lack of adequate manufacturing capacity, and the lag in regulatory guidance are all issues that need to be addressed in order for companies to successfully adapt to these changes.
A hybrid approach to manufacturing
One of the solutions to these challenges is the hybrid approach for manufacturing. This approach involves a combination of both in-house and external manufacturing, allowing companies to benefit from both options. This approach is becoming increasingly popular as companies look for ways to reduce costs and increase efficiency.
When considering a hybrid approach for manufacturing, companies must evaluate their internal manufacturing expertise, scheduling, and robustness of internal quality systems. Companies need to assess their experience in the entire process, and whether they can manage some of the process internally. Scheduling is also a major factor, as the pandemic has caused lead times to increase significantly. Companies must also consider the cost of outsourcing, the experience of the personnel, and the manufacturing demand.
In addition, companies must consider their risk management and quality systems, as well as environmental and safety requirements. Companies must also ensure that they are partnering with a CDMO or CMO with experience, and that they can get into the partner’s schedule.
The hybrid approach for manufacturing offers a number of benefits for companies. It allows for a balance between in-house and external manufacturing, allowing companies to take advantage of both. It also allows companies to reduce costs and increase efficiency. Finally, it allows companies to take advantage of the expertise of external partners, while still maintaining control over their own processes.
In conclusion, the hybrid approach for manufacturing is becoming increasingly popular as companies look for ways to reduce costs and increase efficiency. Companies must evaluate their internal manufacturing expertise, scheduling, and robustness of internal quality systems. Companies must also consider their risk management and quality systems, as well as environmental and safety requirements. The hybrid approach for manufacturing offers a number of benefits for companies, and is a great way for them to take advantage of both in-house and external manufacturing.
Planning for flexibility
When designing new facilities, companies must take their future development goals into account. Flexibility is key, as it allows for expansion and process optimization. Companies must consider their pipeline and expected market demand, in order to determine how much flexibility they need. It is important to take a step back and evaluate what the goals are for the future, as this can save time in the design process.
The type of manufacturing equipment and systems recommended for companies to remain agile and compliant with GMP depends on the company’s requirements. A combination of both single-use technology and stainless equipment or alloy might be recommended, depending on the contamination control strategy and compatibility requirements. Additionally, there have been advancements in materials for cleaning and testing techniques, which can enable companies to use stainless and alloy equipment.
Overall, companies must plan for flexibility when designing new facilities. This involves taking into account future development goals, evaluating the pipeline and expected market demand, and selecting the right type of manufacturing equipment and systems. By planning for flexibility, companies can save time and money, while also ensuring that they remain agile and compliant with GMP.