Amy Zhang, the Head of Supply Chain at Luye Pharma, recently spoke with us about her experience working with Bachem.
Could you give us a short introduction to the company?
Luye Pharma is an international pharmaceutical company. The headquarters is in China and our products are present in more than 80 countries worldwide. We are focused on the central nervous system and oncology therapeutic areas. Our strong technology is in innovative drugs, special for drug database delivery technology, including microsphere and liposome and transdermal drug delivery system. And we also have biological antibody cell therapies and gene therapies.
What are some of the challenges you face in filing new drug formulations for generic peptide APIs?
We think the biggest challenge is from the Chinese authority. Their request for APIs is stricter and stricter. The officer will combine the request of US and EU and Japan and China and select the highest standard. So now maybe China’s standard will be the strictest standard, if a company has a DMF, we cannot say, this company can pass that registration in China. That’s the big challenge.
What challenges are you facing in innovative drug development and delivery?
Luye Pharma is a finished product manufacturer. We have no API. So our API source is from our supplier and the CMO partner; if our innovative drug can be approved or not, it not only depends on ourselves, but also depends on our suppliers. If the suppliers stop the supply of API to us, we face a big risk. That’s also the challenge for us.
What criteria did you use to evaluate potential partners?
To avoid a supply risk Luye will do a comprehensive audit. It’s not only a GMP audit. We also audit the business conditions, EHS, finance, supply capacity, registration capability, API R&D capability, and so on.
Why did you decide to start working with Bachem?
Bachem is the most famous peptide company in the world. So when Luye was starting the peptides project, the first company we contacted was Bachem. Very fortunately Bachem also choose Luye and Bachem is very, very professional and has very good cooperation. Luye is very happy to work with Bachem.
How has the experience been collaborating with the team at Bachem?
Bachem is Luye’s true partner. Our first supply agreement was signed in 2011. It shows the cooperation between Bachem and Luye is for more than 10 years. During 10 years, employees change. For example, the first contact person was Hanspeter. He’s really a very nice person. Now he retired, but after Hanspeter, Gary, and Aya are also very kind supporters, they show very, very good company culture of Bachem, I think. Just can say Bachem is really is indeed the number one.
How has the experience been?
I was really impressed with their industry experience and expertise, especially the fact that they’re in multiple sites and we’ve actually worked with multiple people in multiple sites and everybody was very knowledgeable and very efficient in responding to our needs. We were very impressed. We’ve been working with some of their people in Switzerland and the US and in Japan, and everybody has been great in terms of coordinating and providing us feedback as soon as possible.
Working with Bachem definitely feels like a partnership. We are basically talking with them on a constant basis. Their response time is great. If there were specific needs we had, they were doing their best to accommodate. I would say that the team is phenomenal and I’m very happy working with them. I’m definitely considering working with them again if we have any future projects that require their expertise.
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