Meet the CDMO of the future

30-Sep-2021

What does it take to be a CDMO of the future? It takes a solid foundation of expertise. An unwavering commitment to optimisation. And perhaps most importantly, the experience and willingness to balance one against the other. Here at Asymchem we realise that as strong and reliable as our current solutions are today, tomorrow’s successful partnerships and healthcare breakthroughs rely on new technologies and improved methodologies

Today’s solutions. Tomorrow’s innovations.

We’ve gained our knowledge over 20 years helping the world’s top pharma companies launch new therapeutics and secured that reputation through an unrivaled compliance record. Our culture of continual improvement is deep and underpinned by substantial investment in new technologies. The result? We’re positioned to leverage big pharma experience to assist smaller, specialty therapeutic developers and emerging biotech companies — tomorrow’s innovators.

Seeking answers, dedicating resources

Our one-stop CMC services support the full lifecycle of drug development — from early clinical stage to commercial stage, including R&D and cGMP production of advanced intermediates, APIs, formulations, as well as clinical research services.

Through deliberate investment and strategic partnerships, we’ve made numerous advances in novel technology and green chemistry, including the commercial-sized application of flow chemistry in API manufacturing. Beyond the obvious ability to meet — or exceed global environmental regulations — these green initiatives have proven to deliver short-term efficiencies and long-term cost savings for our customers.

Three-pronged approach to sustainable innovation

It’s true that developing and manufacturing the drugs we need to cure or treat diseases, improve care, and decrease suffering can have unintended environmental impacts and hefty price tags. Today, both the US and Europe require pharmaceutical companies to take responsibility for environmental impacts across their entire drug development lifecycle and environmental standards have become more stringent everywhere.

As a forward-looking CDMO, we anticipated this shift years ago and began intensive investment in three key areas: green chemistry, process efficiencies, and strategic collaborations.

First, lead the way with green chemistry

For nearly a decade, we’ve been exploring and applying green chemistry advances for our customers’ benefit. Today those efforts fall into four key areas: flow chemistry, electrochemistry, enzymes, and photochemistry.

Our dozens of international patents attest to our success as pioneers in the application of flow chemistry to drug production. But it’s the inherent efficiencies of flow that we’re most proud of. For certain processes, flow offers the ability to scale up production safely and cost- effectively and has become the cornerstone to our commitment to waste reduction and sustainability.

We were intrigued by the challenge faced by discovery chemists. While they continue to make great strides using electrochemistry to synthesise new molecules, scaling their results beyond a few hundred grams of product has proven tough. By marrying electrochemistry with flow chemistry, however, we’ve overcome that challenge to support this often highly chemoselective methodology.

In recent years, enzymes as biocatalysts have caught our attention and fuelled additional innovation. We’ve built our own enzyme library, developed fast enzyme screening and evolution, enlarged fermentative production, and even discovered the possible applications of immobilised enzymes in this industry. Our high-throughput screening tools — robotics — increase the number of enzymes we produce in house and take advantage of new methods for engineering new catalysts.

Our most recent area of green chemistry focus is photochemistry production. We’re watching as pioneers in this area access new structures and chemical entities in novel ways. As their candidates progress through assays and show potential on a larger scale, these chemists are looking for partners to help them take their drug to market. We’re investing today in practically and sustainably scaling photoredox technology and are prepared to help our customers do the same.

Second, optimise production through process efficiencies

Like many of our customers, we’re chemists and engineers. Guided by science we not only seek answers, we search for innovative, often overlooked, approaches to save our customers time and money while increasing the safety and sustainability of each process. Today our core process efficiencies centre on these five areas:

Catalyst Screening: Our catalyst screening capability tackles problematic synthetic conversions without going to outside specialty companies, leading to more efficient processes, more control, and ultimately cost savings.
Non-Precious Metal Catalysis (NPMC): The precious metals typically used as catalysts in pharmaceutical manufacturing keep costs high and efficiencies low. Working in-house and in collaboration with industry and academic leaders, we joined the NPMC Consortium and developed procedures that use non-precious metal catalysis to challenge cost, abundance, sustainability, and waste inefficiencies.
PPQ Readiness: Before NDA filing, Asymchem works with customers on the process validation (PV) enabling work (pre-PPQ) that will deliver a robust commercial process. Using our extensive experience, we recommend starting materials, intermediate specifications, proven acceptable range (PAR) parameters, and CPP identification that all work together to smooth the process down the road.
Process Intensification: Asymchem innovations in Process Intensification (PI) result in reduced production time, improved yields, and safer processes. Our dedicated team of engineers and chemists can perform modelling supported by lab experiments and data to ultimately use fewer inputs to get more output.
Solvent Recovery: Because solvent is almost always the single biggest input in the drug manufacturing process, we’ve focused on optimising solvent recovery. By capturing, recycling, or reusing solvents, we’re increasing process intensification and reducing the environmental impact from operations — even eliminating the need for solvent incineration.

Third, collaborate for a brighter future

At Asymchem we believe that collaborating with our colleagues around the world — joining with them to share ideas and learn about new innovations — is how we’ll grow our business and help to make the world a healthier, safer place. To that end, we consistently engage in strategic relationships with industry colleagues and academic researchers.

We’ve joined the Non-Precious Metal Catalysts (NPMC) Consortium, bringing together those who share a common interest in developing more sustainable alternatives to common metal- catalyzed cross coupling reactions, and encouraging rapid uptake of greener technology by placing all results in the public domain.

We’re also a highly engaged member of the ACS GCI Pharmaceutical Roundtable, working to stimulate innovation and integration of green chemistry practices in the pharmaceutical industry.

In addition, we’ve initiated external research collaborations and have hosted several green chemistry symposiums.

Balancing what works ... with what’s next

While some CDMOs may be content to rest on their proverbial laurels, counting on what’s worked in the past to propel them to success in the future, here at Asymchem, that’s just not in our nature.

Whether we’re supporting emerging biotech companies or smaller, specialty pharma, our mission remains to accelerate the launch of new drugs, providing one-stop CMC services for the full lifecycle of drug development. And that requires going beyond what’s tried and true to innovate for what’s around the corner. Our dedication to green chemistry, more efficient processes, and strategic collaborations are working together to meet tomorrow’s challenges.