By Bachem AG
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AMW counts benefits of collaboration with Bachem in development of anti-cancer implants
Bubendorf, Switzerland: – Specialist in biodegradable slow-release drug delivery implants AMW has paid tribute to its collaboration with leading CDMO partner Bachem AG in enabling development of innovative cancer treatments.
In an interview, AMW GmbH Chief Operating Officer and Chief Financial Officer Philipp Karbach explained that partnership with Bachem and access to its active pharmaceutical ingredients (APIs) had been a key advantage in allowing his company to scale up development of its innovative implants for treatment of prostate and breast cancers and establish secure supply chains, even during the worst of the COVID-19 pandemic.
“Bachem has always been a reliable production partner, who has helped us secure supply and also scale up significantly, which is key in generic markets where you can rapidly gain market share,” Mr. Karbach reflected.
“We could always count on Bachem to comply with our needs in supply to achieve our demand, during the pandemic and in other challenging situations. Thanks to the team supplying us with the requested quantities, we can ensure that adequate supply reaches the patients,” said Mr. Karbach.
AMW has now produced and sold more than 650,000 implants worldwide.
“Throughout the development process, Bachem’s expert teams have supported us in any possible way and in a timely manner to answer open questions or to overcome challenges. When it comes to opening up new markets, especially those with high entry barriers, Bachem has been very supportive, using their experience in a straightforward manner throughout the process,” Philipp Karbach explained.
Overcoming regulatory challenges
He noted that one of the main challenges facing AMW in developing innovative drug delivery platforms was to stay in step with continuous changes in the regulatory framework and incorporating APIs that achieve the sustained release that meets the requirements of the drug profile.
Sourcing APIs from Bachem for two key products meant that significant part of the regulatory burden could effectively be outsourced.
“By providing the appropriate documentation level and with the responsiveness of experts for additional questions, Bachem is the right partner for us to mitigate any risk within the regulatory process. The typical challenges throughout the regulatory process are questions being raised and additional data requested, which is usually to be supplied within a very short timeframe. Having response rates that are very short is therefore key in this process, and we could always count on Bachem to meet these timeframes imposed by the regulatory bodies,” said Mr. Karbach.
Bachem expertise had also been a huge plus factor.
“Since AMW is developing complex drugs / combination products, we come to a point where expert knowledge is key, especially when it comes to difficult technologies like biodegradable implants. Also, during the manufacturing of market goods, it is of great advantage for us to have access to Bachem’s experts,” said Mr. Karbach, noting that the biggest single benefit of working with Bachem was high level of trust in the relationship.
“It’s a true partnership in all areas of business. From the start, we found a very supportive environment, being invited to make use of Bachem’s expert knowledge, also in terms of regulatory documentation throughout the whole process, among others. We also experienced Bachem as a reliable partner you can count on for securing the supply of market goods, also in times of upscaling,” he concluded.
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.
Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
For further information, see www.bachem.com.
Founded in 2008 at Warngau in Southern Germany, AMW GmbH has become a leader in the development and manufacture of biodegradable slow-release drug delivery systems such as implants as well as first-to-market generics.
AMW also uses its leading edge galenic formulation expertise to support partners in the development of new products based on its proprietary technology platforms, with particular focus on indications such as oncology, neurology, endocrinology, ophthalmology, and pain treatment.
The company has become the largest employer in Warngau, with more than 100 staff. It is now one of the largest developers and manufacturers of biodegradable implants worldwide.
To learn more, visit AMW at https://a-m-w.eu/en/