Celltrion

Most of today’s developments in the pharmaceutical sector have been driven by technology. Relative to what we can see now with current orthogonal methods, the approaches we utilized in the laboratories around 20 years ago were not particularly sophisticated. Currently, things that we previously did not understand have become considerably clearer. That makes it easier for researchers to look beyond what they expect to see and see things they could not have noticed a few years ago.

In your general experience, what would you say are some of the new objectives in the research field regarding the pharma industry?

I consider that recognizing the data gathering capabilities along with artificial intelligence and the IoT will play a key role in how the pharmaceutical industry evolves. Now, the pharmaceutical is a work-focused environment. What you have done in the past has to remain the same because of regulatory requirements. However, once you recognize that there are new approaches that can enhance and improve what you've been doing in the past, and that these improvements can be safely implemented and defended, I believe that many more organizations will adopt these new technologies to be nimbler in how they progress in the manufacturing of the products or product discovery.

As a vice president at Celltrion for global drug product expansion, what would you say are some of the best practices you have employed to stay ahead of the many new challenges the industry is witnessing?

Keeping up with the basics of what Good Manufacturing Practices (GMPs) are about, understanding the regulatory guidelines, and adhering to those guidelines are some of the best practices. Even if new technologies offer benefits, if they have not been proven, we will likely opt not to utilize them because they will demand more scrutiny from regulatory agencies. As a result, we stick to the basics while incorporating new technologies that have been demonstrated in the field, such as isolation technology, which many companies have avoided for many years and now is becoming the new standard due to regulatory requirements, requiring that products are protected from exposure to the external environment. Many companies are moving in that direction, which, once again, goes back to the basic principles of protecting the product and ensuring that aseptic operations are not jeopardized by exposure to the personnel performing aseptic manipulations. The key elements that have contributed to our success are understanding and implementing regulatory requirements, albeit with strategic investments, for safeguarding the products and employing proven technologies already vetted by regulators.

What advice would you share with budding entrepreneurs within the pharma industry? 

Entrepreneurs should know that the pharmaceutical industry is a fundamentally distinct field. What appears to be common sense does not always apply to the sector. As a result, they must make a mind shift in terms of how they develop their manufacturing operations. For instance, one of the features of regular manufacturing work is that people are required to be efficient which relates to operational speed. Not so in the aseptic environment. Fast movements go against good aseptic practices. Swift movements or walking at a quick pace can cause turbulence in the area disturbing particles that could potentially affect the product; therefore, operators are trained to move slowly, which in the normal mfg. environment will be considered inefficient.

Also, the pharmaceutical environment is very bureaucratic and highly regulated, so if we say we're going to perform a process requiring several steps, which may include multiple decisions points, we cannot deviate from these steps even if we find short cuts that could be applied, the approved steps must be always executed. If we deviate from the process, it will result in deviations, which will be questioned by regulatory agencies and will have to be justified, rectified, potentially affecting product already released in the market, leading to recalls affecting the company’s reputation. As a result, budding entrepreneurs need to clearly understand the pharma industry requirements, its GMPs, GDPs, GEPs, qualification protocols, regulatory expectations, etc. and how these will impact the growth of their companies, their day-to-day operations, no withstanding future preventive maintenance and prospective upgrades/changes that they may need or wish to implement to improve their manufacturing operations.

Would you like to share something from your personal experience or a story of yours that could add value?

For many years, drug product (DP) mfg. was not well understood by the local Korean pharma industry. Companies with aseptic filling processes mistakenly thought that DP mfg. was only filling vials or syringes, with minimal procedures to control the process. This behavior led to failed regulatory inspections. This caused companies to outsource their DP mfg. operations to foreign regulatory approved contract manufacturing organizations (CMOs). Although outsourcing allowed them to sell product internationally it also came with inherent challenges. The absence of local regulatory approved DP facilities combined with the use of international CMOs impacted the investment in local DP mfg. facilities and technologies. For instance, commercial isolators which have been in use in Western companies since the eighties, were not even considered in Korea until recently. Celltrion, on the other hand, recognizing that investments in proven technologies are key to growth, begun preparations for a new PFS pre-filled-syringe facility in 2018 implementing state-of-the-art technology and in 2021 attained MFDS and EMA regulatory approvals of the first commercial Isolator on a pre-filled syringe (PFS) line, and the first high-throughput automatic auto injector assembly machine. Celltrion’s DP mfg. operations international regulatory approval track record started in 2013 leading the way on this field.

Our success in the DP area opened the pathway for other companies to invest in DP mfg. operations and now we see new companies strengthening their understanding of regulatory expectations, investing in hiring experts to help them navigate the dynamics of complying with existing regulations while implementing new technologies. To date, more companies are exhibiting compliant DP operations, and many more are developing programs to help them go through the intricate process of implementing regulatory compliant DP mfg. operations.