Unpredictable. Uncertain. These adjectives have become par for the course in today’s conversations about planning and meeting essential healthcare goals of the world’s population. Closing gaps in unmet needs is one aspect. However, a less appreciated but paramount aspect is the supply of solutions.
The COVID-19 pandemic was a breakpoint moment in modern history – the realization that global change happens fast and unexpectedly and that effective responses require resilient supply chains. Roche’s nucleotide production is an example of the adaptive scaling and secured provision that forges resilience. It is a robust and flexible infrastructure that builds on longstanding expertise, cutting-edge technology, the highest standards of quality, and a team committed to making a difference.
Dr. Tobias Hausmann is the Head of the Department for Production of Biosubstances and Nucleotides. He’s the first to tell you how many pieces must come together to create an adaptable and reliable production.
Roche CustomBiotech is renowned for delivering high-quality reagents that meet stringent industry requirements.
Dr. Tobias Hausmann
Head of department for production of biosubstances and nucleotides
“But we also know that meeting those needs means more than having a good production scheme. We need to be reliable, we need to provide necessary documentation, we must ensure a stable process, and we must guarantee the utmost commitment to quality every single day.”
How does Roche CustomBiotech do that? “Well, it starts with truly committed people. The dedication and flexibility of our manufacturing team during the pandemic were unparalleled and remain a defining characteristic of our company culture,” explains Hausmann. “I am really proud of that.”
Dr. Steffen Gaali, the Head of Nucleotide Production agrees. He highlights the herculean efforts and personal dedication of his team during the pandemic response: “We needed to produce an enormous quantity of nucleotides in a very short time to enable PCR testing for SARS-CoV-2 worldwide. All employees were very aware of their responsibility and impact on society during this time. The nucleotide team showed full commitment, be it with flexible working hours, weekend work, accelerated process optimization, or the rapid "upscaling" of processes where possible.”
The human element behind Roche’s nucleotide production is coupled with a significant investment in modern infrastructure and an innovation pipeline to meet the ever-changing needs of biomanufacturers. “We are prepared for the future, whatever may come, because we consider customer requirements from the point of ideation forward,” says Hausmann.
“Today, the knowledge we have gained from almost 30 years of nucleotide manufacturing allows us to produce them animal-origin-free.”
That transition to animal-origin-free nucleotides meant transferring a new biotransformation process to large-scale production and building a 400-square-meter production facility. Expanding Roche CustomBiotech's commitment to environmentally friendly practices, the biotransformation of NTP production features a green enzymatic process that eliminates organic solvents from production.
“The production line is exclusive for animal-origin-free NTPs,” shares Gaali. “We’ve designed and constructed it specifically for active pharmaceutical ingredient production based on our decades of experience and following every quality standard that Roche strictly upholds. That includes our responsibility to the environment as we use green aqueous chemistry.”
The cutting-edge production facility is equipped with high-end, state-of-the-art instrumentation for customized automation, dedicated purification columns, and modules for ultrafiltration and nanofiltration of each nucleotide. Hausmann describes the impact of the entire production system: “With our team in these outstanding facilities operating a contained manufacturing process that spans every step, including precursors, we are able to flexibly, reliably, and quickly adapt production scale to more than double nucleotide output.”
Dr. Steffen Gaali
Head of nucleotide production
Roche CustomBiotech has three decades of experience and knowledge in designing and manufacturing NTPs. Our diverse portfolio covers a spectrum of chemistry and formulation features that meet the needs of various biomanufacturing applications. In fact, our experience in diagnostics and supplying dNTPs has been indispensable in delivering nucleotides worldwide in quantities and quality that attest to our supply capacity, whatever the need or scale.
As of today,” shares Gaali, “we have produced over 40,000 L of nucleotides, enough for over 100 billion standard PCR tests, and we take great pride in having maintained an average purity of 99.9% across the last 1000 lots of dNTPs.”
Today, our exclusive production line for animal-origin-free (AOF) NTPs is specially designed to meet the stringent requirements of biopharmaceutical manufacturing, including AOF and extended impurity testing as important key quality attributes. This ensures the highest standards of safety for any final product manufactured with them. Housed in our state-of-the-art facility, this dedicated production line demonstrates our technical expertise and unwavering dedication to environmental protection and quality.
Our commitment to providing a consistent and high-quality supply of these essential raw materials sets us apart in the biopharmaceutical industry. We strive to exceed expectations by maintaining an exemplary level of environmental stewardship and responsiveness, making us a trusted global partner for a brighter future.
