In process development and production, making a molecule in the lab is only the beginning. What comes next is turning that initial synthetic route into a robust, scalable process that can advance into clinical phases and beyond, batch after batch, year after year. What it demands is an uncompromising commitment to quality in each and every batch, because quality is designed into the process upfront, not inspected into the product later.
Qixuan Lu has spent nearly twenty years at BioDuro, now as Senior Vice President of Process Development and Production. That commitment to quality has long become something closer to instinct, the most concrete expression of his pursuit of excellence. He found a place where he could immerse himself in the work he loves, with the room to pursue the best, and let that commitment to quality take root.
Qixuan's commitment to quality shows up far beyond the lab.
There is a corner of Qixuan's house that his colleagues would find immediately familiar. The scale. The timer. The variables, tracked and adjusted until the result is exactly right. The only difference is that here, the product is coffee.
With a pour-over, one wrong variable can throw off the whole cup, and Qixuan has them all dialed in. Different beans, different roasts, different water temperatures, and a different rhythm of pour. "You can’t get a great cup by accident," he says, "Every variable has to be right, and you have to know why."
The same goes for the gym. He lifts, he swims, and lately he's taken up Hyrox, going deep on the nutrition science behind his training. It's not about bulking up. It's about control, knowing exactly what each variable does, and adjusting until everything finds its balance. There's badminton too. He picked up at his daughter's lessons, and then hired his own coach, got good, and before long was running the company's badminton club.
Outside the lab, he’s still running his experiments — life is where he runs them. For Qixuan, the commitment to quality runs through everything: a pour-over, a workout plan, a badminton hobby, a synthetic route. Quality isn’t something he aims for. It’s something he lives by.
Before joining BioDuro, Qixuan had spent several years in the generics drug industry, on the CMC side. The molecules were already on the market with their patents expired. The specifications were established, and the job was to develop a reliable, cost-effective process for a known molecule and file it. Steady, predictable work, and over the years, a way of thinking he’d grown used to.
Then, he joined BioDuro in 2007, but the CMC for innovative drugs worked nothing like the generics. The regulatory and quality bar was completely different, and he had to build a robust, scalable process from the ground up, batch after batch, all the way from the pre-clinical toward commercial production. The fundamentals of CMC hadn't changed, but the mindset had. Qixuan had to recalibrate his own thinking, the way he'd later dial in a pour-over or a training plan.
"Moving from generics to innovative drug CMC changed the way I think," Qixuan says. "The deeper I dug into what quality really means, the more it changed how I see things, not just in CMC, but in everything. Quality can be an attitude, a mindset, or something built into who you are." He's been at BioDuro ever since, building a team that carries the same devotion to quality he holds himself, no matter how challenging the molecule is.
So, what does that uncompromising quality actually look like in practice?
Ask Qixuan, he talks about a river. He grew up in Hubei, China, along the middle reaches of the Yangtze River — Asia's longest river and a cradle of Chinese civilization. A river that has carried what matters, steadily and without interruption, for thousands of years. “Picture that river,” he says, “and a boat moving downstream, carrying its cargo safely to port. But getting there is never straightforward. Even when the surface looks calm, there are rocks beneath it.”
"In my CMC work, my job is to deliver products that meet the quality standard," Qixuan says. "Those rocks are what put the quality at risk. They might be a reaction temperature drifting, a side reaction that didn't raise a flag in the first few runs, or an intermediate degrading while sitting between steps. And above all, there is impurity control. At lab scale, an impurity might sit well within specs. But at larger scale, the process behaves differently. What was never a concern in the lab can rise to levels that fail a much larger batch.”
It’s about quality mindset being built into process design from the very beginning, shaping how the process is developed rather than tested at the end. Yield, cost, and robustness are part of that quality mindset from the start, so the process delivers consistent outcomes across scale, from a few grams in the lab through clinical and commercial production.
There’s always a port waiting at the end of the line. Among countless projects over years, one stays with him. A company had come to them with a challenging molecule — one that other CDMOs had walked away from. But for pediatric patients with a rare disease, that therapy was never optional. It could mean the difference between life and death.
Qixuan and his team took it on. He remembers that one of the most challenging parts involved a key starting material. The chemistry was demanding, impurity control posed a constant challenge, and the client was moving against an exceptionally tight timeline.
But getting the chemistry right was only the beginning. What mattered more was whether those early decisions would hold downstream. Was the starting material clean enough to control impurities later in the route? Would the process stay robust as it scaled? Could supply and cost hold over the long run? These are the kinds of questions Qixuan and his team gravitates toward, shaped by years of work in which quality thinking has become instinct rather than a formal framework.
The therapeutic finally reached the market. More than a decade later, Qixuan's team is still part of how the medicine stays on the shelf. None of this was ever just chemistry.
Qixuan was born along the middle reaches of the Yangtze River and now works in Shanghai, where the river meets the sea on its way to the Pacific. For centuries, the river carried people, goods, and ideas across China, connecting places, and lives along its course. Over nearly two decades at BioDuro, Shanghai has become the place where Qixuan built both a career and a life, and where BioDuro helps carry scientific innovation to clients around the world.
For Qixuan, quality is no longer something that requires conscious effort. It has become instinct, shaping how he approaches a project long before risks emerge and helping ensure that good science can keep moving forward, both in work and beyond it.
That instinct can be seen in how his team works and, more broadly, in how the company delivers science. Being rooted in science only matters if science can be delivered. Quality is what helps move science forward, precisely and reliably, from discovery through development and ultimately to the patients in need.
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