“Wavelength’s strategy to continuously invest in its supply chain has proven itself during the Covid-19 pandemic”

#SpeakPharma with Wavelength Pharmaceuticals

2020-08-06

Impressions: 4168

This week, SpeakPharma interviews Ilan Avni, Vice President, Business Development at Wavelength Pharmaceuticals, an independent API company supplying the world’s surging demand for Covid-19 respiratory critical care products. Avni tells us about Wavelength’s strategy of continuously enhancing its supply chain, including backward integration, to control production of advanced intermediates and key starting materials. And how this strategy has helped the company better address the ongoing Covid-19 crisis.

— Tell us about your company, its genesis and how it has advanced over the years.

We are a world-class developer and manufacturer of active pharmaceutical ingredients (APIs) with a long heritage of excellence and an impeccable regulatory track record. The company was founded in 1987 as Chemagis. In 2005, the company became a part of Perrigo and then in 2017, it was acquired by SK Capital Partners and was renamed Wavelength Pharmaceuticals.

SK Capital is a New York-based private investment firm focused on pharmaceuticals and specialty chemicals. It manages a US$ 4.6 billion portfolio comprising 12 companies.

The name Wavelength was selected to highlight the company’s customer focus. We feel the name and our “Always Aligned” approach symbolize what we are — on the same wavelength as our customers and always aligned with their needs.

— What are some of the advances made by Wavelength Pharma in the field of custom synthesis? In which formulations is this process used?

Wavelength has more than 33 years of exceptional regulatory track record with all leading global regulatory authorities and has had over 100 audits in the past five years to confirm its spotless reputation.

More than 250 drug manufacturers across the world rely on Wavelength for the development, production and reliable supply of APIs. Our portfolio comprises of 36 commercial APIs including complex injectables, inhalables, highly potent, cytotoxic and controlled substances. Overall, we produce more than 250 metric tons of APIs every year.

We are experts in complex chemistry, innovative process development, crystalline forms and particle design. We offer customized solutions to meet individual customer requirements including full spectrum API CDMO services, from pre-clinical grams to multi-ton commercial scale, with complete regulatory support. The same strong culture of quality, regulatory compliance, robust supply chain, development and scale up methodologies, that has served Wavelength’s API business for decades, is implemented in our API CDMO services. And our customers are well assured of continuous regulatory compliance and uninterrupted supply.

Our API CDMO customers know that when they come to us, we have all the required capabilities and the flexibility to accommodate their growth.

— What has been the impact of Covid-19 on CDMOs?

The recent Covid-19 pandemic has re-emphasized the need for all drug manufacturers to continuously enhance their supply chain for strategic products. This includes prioritizing suppliers with a spotless regulatory compliance track record and a firm quality culture, who are continuously investing in improving and strengthening their own supply chain.

While working with contract manufacturing organizations (CMOs), it is extremely important to make sure your CMO not only has available capacity to match your future demand, but also has the development expertise and experience to quickly scale up production and further optimize your production process to swiftly expand capacity and throughput at times of increased demands. This strategy has allowed Wavelength to continue uninterrupted supplies and even triple and quadruple its production of Covid-19 related products during this global crisis.

— How is Wavelength Pharma coping with the pandemic? Can you speak about your Covid preparedness?

Over the years, Wavelength has continuously invested in enhancing its supply chain through backward integration. This has helped us develop better control over production of advanced intermediates and key starting materials. Having the option to apply these earlier steps in-house, if required, or to transfer the knowhow for quick implementation by an alternate supplier, is an important contingency with proven utility across many different projects. Moreover, we are also making sure to qualify additional, reliable suppliers from different geographies, and carefully plan and maintain sufficient inventory levels.

This strategy has greatly contributed to our preparedness for the Covid-19 crisis. Together with our team’s vast experience in process optimizations and scale-ups, we were able to substantially expand production of APIs for products needed to manage respiratory critical care of Covid patients. Demand for products like Midazolam, Cisatracurium, and Rocuronium has skyrocketed as a result of the global coronavirus pandemic.

The commitment of always being aligned with our customers’ changing needs is what drove Wavelength to invest in the required capabilities and expertise. As a result, we are able to respond very promptly to the urgent need for critical care respiratory drugs, required to treat Covid-19 patients.

— What does future (in the post-Covid world) look like for Wavelength Pharma?

We are proud of our highly experienced team that is working tirelessly to triple and quadruple our production and supply of essential APIs for Covid patients globally. Our commitment to being ‘always aligned’ with the needs of our customers drove us to invest in simplifying and de-risking our supply chain, as well as building the required capabilities and expertise that now allow us to respond quickly during these challenging times.

We believe the same strong culture of quality and regulatory compliance, together with our robust supply chain, development and scale up methodologies, can create tremendous value for our API CDMO customers. We have all the required capabilities and flexibility to reliably meet shifting customer needs. We are keen to help our customers bring their own products to market and provide them assured sustainable quality and regulatory compliance with uninterrupted supply to support their growth.

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— Tell us about your company, its genesis and how it has advanced over the years.

— What are some of the advances made by Wavelength Pharma in the field of custom synthesis? In which formulations is this process used?

— What has been the impact of Covid-19 on CDMOs?

— How is Wavelength Pharma coping with the pandemic? Can you speak about your Covid preparedness?

— What does future (in the post-Covid world) look like for Wavelength Pharma?