Protein Sciences

Uniting Drug Development Expertise with Antibody & Protein Production Services

Beyond Protein Production: WuXi Biologics’ Protein Sciences Accelerates the Path to CMC

Focused on the research stage of the drug development process, the Protein Sciences (PS) Department is one of the main entry points for future CMC projects at WuXi Biologics.

Not just another protein maker

Some companies just need an outsourcing partner to produce proteins, and WuXi Biologics’ Protein Sciences (PS) Department certainly stands out as a reputable option. However, for organizations who need more than protein production and want to develop a molecule for therapeutic purpose, it’s important to find a partner with drug development experience.

“As a CRDMO, WuXi Biologics has advanced more than 600 molecules into Chemistry, Manufacturing, and Controls (CMC) projects,” says Jiansheng Wu, Ph.D., head of the Protein Sciences. “Many CROs exists, but most can’t claim to be drug developers like we can.”

That’s why the key message within WuXi Biologics’ PS Department is: Not just another protein maker. With extensive drug development experience, Protein Sciences is well-equipped to help partners progress their molecules into CMC.

Protein and antibody production services—with an eye on CMC

This blog article is about how WuXi Biologics’ Protein Sciences Department goes beyond protein production to accelerate the path to CMC for customers.

In order to help clients advance a molecule from the research stage to CMC, experienced teams within PS Department offer guidance and advice on how to create a drug-like molecule.

The process involves addressing the three important questions during the research phase. How well is your molecule being expressed? How well does your molecule perform during purification and scale-up? And how stable is your molecule?

“We provide valuable insights and guidance to clients throughout the entire protein and antibody production process, enabling clients to avoid common pitfalls and overcome challenges,” says Dr. Wu. “Our comprehensive end-to-end approach to protein production helps ensure a seamless and successful journey from concept to market.”

Offering solutions to overcome protein production challenges

Recently, a client came to PS with concerns about the stability of an enzyme-fused antibody. Teams within the department produced the client’s protein, but there were degradation issues that resulted in poor quality. To solve the issue, the teams used Mass spectrometry to locate the cleavage site. They also advised on how to solve low productivity issues by optimizing the protein’s construct. The solutions helped the enzyme survive in harsh production conditions.

“After a year of work, the client’s molecule is now ready for CMC,” says Dr. Wu. “The protein has no cleaving, good stability, and we increased its expression level by more than 30-fold. This is what separates WuXi Biologics from other CROs. We produce proteins in the context of knowing what’s feasible to progress to CMC in a high-quality, efficient, and cost-effective manner.”

Chengdu Facility in China

In 2022, the PS Department helped another client go from early R&D to GMP manufacturing. The client had a recombinant protein that expressed at 5 mg/L in a shake flask. They contracted PS to produce it, intending to go into CMC. Teams optimized the shake flask expression conditions and increased the expression levels from 5 mg/L to more than 80 mg/L. They also made changes to the construct to enhance protein productivity and optimized the purification process. The project successfully advanced to GMP manufacturing.

Meeting clients’ “burning needs” with innovation

Innovation is essential in the competitive biopharmaceutical industry. That’s why we foster a culture of innovative thinking among its team members.

“Every year, I visit the sites of more than 100 clients, because I want to understand their burning needs,” says Dr. Wu. “During a particular client meeting, the group said their burning need was to find the best pairings in the production of bispecific antibodies. So, we invented the Quick ‘n’ Clean platform to meet their need. Our goal is to offer exclusive services that no other CRO offers.”

Since that meeting, the Quick ‘n’ Clean service has been used to produce thousands of bispecific molecules for clients around the world. So innovative was the Quick ‘n’ Clean platform, it was named a finalist in the Novel Product Award at the 2023 Merck Technology Symposium.

With more than 600 integrated projects, and 22 in clinical or commercial manufacturing, WuXi Biologics stands out as a reliable partner in antibody drug development. Equipped with such extensive drug development experience, the PS Department goes beyond protein production, offering a holistic approach to accelerate the path from molecule to therapeutic drug.

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