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ONCOLOGY CONTRACT WITH ONCOGEN PHARMA IN MALAYSIA. In an industry first for the company, GEA signed a memorandum of understanding (MoU) with Oncogen Pharma (Malaysia) Sdn Bhd in 2019 and shook hands on a multi-million Euro contract to supply a suite of equipment for the production of oral solid dosage (OSD) forms to treat cancer.

ONCOGEN PHARMA.

Based in Malaysia, it is one of the fastest growing pharmaceutical companies in the country and has a large portfolio of oncology products under development. The deal represents GEA’s first ever oncology/anti-cancer reference in Malaysia and comprises a GEA rotary tablet press, a granulation line, downstream processing and containment equipment — an end-to-end solution.

CELSUS plant is strategically located near the Kuala Lumpur International Airport at Enstek Park, Malaysia, and includes some unique features:

• completely automated, respirator-free, OEB 5 category high-containment plant

• designed by international engineering firm according to CbD

• (containment by design) principles • environmentally friendly, 100% zero-discharge facility • target accreditations: USFDA, EMA, PIC/s, WHO, GMP, etc.

• Multi-product, versatile facility with flexibility to handle varied batch sizes (grams to kilograms).

A vertically integrated research-based pharmaceutical company with a global outlook for cancer treatment.

2 Oncogen Pharma.

Having designed and built the integrated line with a PharmaConnect unit equipped for both small- and pilot- scale applications, further discussions between Navin Lakhanpaul, Vice President, Solid Dosage BU Pharma & Health, and Oncogen’s CEO, Rahil Mahmood, suggested that there may be scope for expansion in the future to align with growing capacity. The company has further plans to expand its manufacturing footprint in many countries to reach cancer patients across the globe.

However, the project was put in jeopardy when the COVID-19 lockdown threatened to prevent key milestones being reached. “Although the Project Management and Execution teams had been doing an excellent job, and both fabrication and assembly had been completed, there were hurdles to overcome in the workshop,” notes Raman Singh, Pharma Sales responsible for Asia-Pacific, GEA: “We needed to be able to complete the Factory Acceptance Test (FAT) to remain on schedule.”

Given the social distancing measures that had to be enforced, that travel was almost impossible and no external people were allowed on the shop floor, a solution needed to be found. “Fortunately, the customer was able to engage a local third-party agency to represent them, who was granted access to witness the FAT, and we employed a remote system of video conferencing, digital images and online communication,” says Raman.

“Our staff worked very long hours to complete the task,” he adds, “which sometimes involved up to 7 hours of actual labor followed by 3 hours of video calls. The Quality Assurance (QA) people were very thorough and we had to provide not just a visual update, but documentation as well. We tried our very best to remain on schedule, but there were a lot of questions to answer, especially as the visitor needed to become familiar with our machinery and the current state of the project, so there was an educational and coaching aspect of what we had to do. This all added both time and complexity to the process.”

“It was, however, an enlightening experience,” continues Raman, “and means that we’re now well prepared to implement a similar solution should another remote FAT be required. In fact, it’s now part of our new normal and something we’ll be offering as standard. And, despite the delayed FAT, the customer is happy with the outcome and the progress that GEA was able to make — even during lockdown — especially in terms of compliance, documentation and our ability to deliver high quality machinery in unprecedented times.” The equipment is now ready to be dispatched and operational by the end of the year.

With Pioneer status in Malaysia, Oncogen expects to hold more than 50% market share with its robust product pipeline, which is due to be commercialized after 2022.

We are well known as experts in this field and recognized as a preferred supplier and an authority when it comes to designing and constructing top-of-the-range equipment. Raman Singh – Pharma Sales responsible for Asia-Pacific, GEA.

3 Oncogen Pharma.

Navin Lakhanpaul, commented: “We look forward to partnering even more closely with Oncogen Pharma in the future and building on this first key oncology reference in the Malaysian market. The long-term agreement we have fostered is testament to the quality, reliability and flexibility of our technology, and is further recognition of our unparalleled reputation in the global pharmaceutical market.”

“The pharmerging market will be an important area of growth for GEA. To succeed in that market, local process assistance, end-to- end solutions and a strong service network to address the requirements of seamless high-volume production will be critical,” added Navin: “GEA’s trusted batch and continuous processing OSD solutions and

process know-how will have a major role to play, complemented by our regionalized supply chains delivering world-class price- performance solutions.”

“It’s never easy to secure a contract like this one,” observes Raman, “which involved a lot of work. As it happens, Oncogen’s current Vice President of Operations, Mr Sandeep Mhetre, played an instrumental role in procuring the order. Having previously worked with GEA on an oncology project for his former company, Biocon, he was already familiar with our technology and enthusiastically shared his trust and confidence in us.”

“We are well known as experts in this field and recognized as a preferred supplier and

an authority when it comes to designing and constructing top-of-the-range equipment. Yes, there’s a premium to pay for robust, reliable and cutting-edge technologies, but the old adage about getting what you pay for is an excellent metaphor and most customers understand that their systems are much more than the sum of their parts,” he added.

He concludes: “We’ve now established excellent relationships with Oncogen’s management, at the very highest level, and hope to capitalize on this burgeoning association as we expand our oncology remit in Asia. We look forward to collaborating with Oncogen as they increase their capacity and global footprint in the near future.”

Further information GEA Pharma & Healthcare pharma@gea.com gea.com/contact

We look forward to collaborating with Oncogen as they increase their capacity and global footprint in the near future.

4 Oncogen Pharma.

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