PharmaLex

In an interview with Pharma Tech Outlook, Patrick Nieuwenhuizen, director and senior consultant at PharmaLex, sheds light on the key strategies and technological advancements driving success in the ever-evolving pharma tech landscape.

What did your illustrious career prior to joining PharmaLex look like?

I started my career in 1994 as a microbiological analyst at a regional hospital in my hometown in the Netherlands. To my surprise, after completing my mandatory army service, I transitioned into the pharmaceutical industry and began working as a microbiological analyst for a biotech company. This unplanned move marked the beginning of a successful career trajectory.

I later joined another company where I played a crucial role in setting up and expanding their microbiology department, and over time took on various positions as a microbiological expert and gained experience in quality assurance. In due course, I moved on to a biotech and sterile manufacturing company, where I assumed the role of a microbiological QC manager and was later promoted to general QC manager.

In 2011, I moved to Ireland with my wife, where I accepted a position as a QC microbiological manager at a global sterile finishing company. Working for a company with a worldwide presence was particularly stimulating, and I became increasingly involved in corporate responsibilities and took on the additional role of stability assurance lead. I remained with the company for a total of nine years.

In 2021, amidst the COVID-19 pandemic, I took up a consulting role in the pharmaceutical industry, specializing in manufacturing, biotech, and pharmaceutical microbiology. With my educational background in pharmaceutical microbiology and extensive experience, this role was a natural fit for me.

I have also contributed to various publications, including the PDA technical report number 90, which focused on examination control strategy in response to the newly published Annex One. This report was a collaborative effort with industry peers and addressed the integration of combination control strategies and quality risk management.

Throughout my career in the pharmaceutical industry, I have delivered numerous presentations on topics such as aseptic and sterile manufacturing, as well as Annex One and its implications. In my current position, I have been involved in diverse projects, ranging from providing training on pharmaceuticals and good manufacturing practices to leading remediation programs for regulatory inspections.

As the director and senior consultant of PharmaLex, what roles and responsibilities do you have to cater to on a daily basis, and what are some of the challenges you encounter?

As the Director and Senior Consultant at PharmaLex, my role involves providing consultancy services in the areas of good manufacturing practice, quality management compliance, data integrity, and aseptic and sterile manufacturing. I leverage my expertise in microbiology, biotech, and ATMP to address client requests for background knowledge in the pharmaceutical industry. If I don't possess the required expertise myself, I tap into the PharmaLex network to find the right person who can assist the client. One significant area of focus is ATMP or Cell & Gene therapy, which entails various projects where we offer support, which includes cell manipulation technology to encompass product stability, contamination control, and beyond.

My colleagues and I provide expertise on Quality Management and Compliance in the broadest sense, managing and controlling contamination and optimizing quality management systems in laboratory and production settings. We also provide QP and RP support and provide expertise in good distribution practices (GDP) regulatory filings. Overall, quality and compliance consultancy in the pharmaceutical world, such as sterile manufacturing, biotechnology, and cell gene therapy, forms a significant part of our services.

"Collaboration and knowledge sharing play a vital role in the world of aseptic manufacturing. Rather than reinventing the wheel, it is important for companies to collaborate, share information, and learn from one another."

Businesses have their own systems, expertise, and capabilities. Identifying gaps and developing a remediation plan requires considering the company's specific needs. Remediation plans may involve financial investments, such as updating outdated production facilities, or personnel investments, such as training employees to enhance compliance. However, limited resources, both in terms of finances and headcount, can pose challenges to implementing these plans. Obtaining adequate support from the company is crucial. At PharmaLex, we not only identify improvement areas but also assist in implementing solutions. However, we cannot do it alone and rely on the company's cooperation. Balancing routine and commercial activities while allocating resources for remediation can be quite a struggle.

What are some of the technological advancements that PharmaLex leverages in the pharma tech landscape?

With the publication of Annex 1, the focus on implementing new technology has become increasingly important. The use of barrier and isolation technology, for example, is now an essential expectation. It is no longer acceptable to rely solely on aseptic manufacturing processes without these technologies. Upgrades to existing lines are expected to incorporate these advancements.

Accessing various systems or utilizing isolation technology is necessary to meet these expectations. Robotics has become a particularly interesting area of development, especially for smaller batch capabilities. By removing human involvement and relying on robotics for sterilization, the impact of human error can be eliminated.

In the field of cell and gene therapy, the emphasis is on ensuring robust processes that prevent microbial or extraneous contamination. This is crucial to guaranteeing the quality and safety of the final product for patients.

In light of the growing popularity of robotics, how do you envision the future of the pharma tech industry?

PharmaLex leverages technological advancements to overcome limitations and improve manufacturing processes. One such trend in the pharmaceutical industry is the installation of multiple isolators instead of a single fill line with high throughput. This allows for simultaneous filling and finishing of different batches, even at different locations. While throughput may be limited, this approach offers increased flexibility and efficiency.

Another significant aspect is the adoption of novel technologies. Rapid microbiological methods, such as real-time detection of environmental monitoring samples and inline measurement of water monitoring, are being increasingly utilized. These methods can detect and differentiate living cells, enhancing the efficiency and accuracy of monitoring processes. Rapid sterility testing is another major development that significantly reduces the time required for sterility testing, potentially shortening the lead time from 14 days to just a few hours. This advancement holds particular promise in the field of cell and gene therapy.

Do you have any words of advice for your peers on how to navigate the complexities of the ever-evolving pharma tech space?

Collaboration and knowledge sharing plays a vital role in the world of aseptic manufacturing. Rather than reinventing the wheel, it is important for companies to collaborate, share information, and learn from one another. This can be achieved through various means, such as reading articles, participating in forums, attending conferences, and engaging in open discussions. By working together and exchanging insights, companies can learn from each other's experiences and avoid repeating mistakes that have already been made.

In cases where additional guidance is needed, companies can seek the assistance of consulting firms like PharmaLex that can provide independent perspectives and expertise to help address specific issues or challenges in the field of aseptic manufacturing.