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    InterviewAll #SpeakPharma
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    “We’ve quadrupled our production and added new customers during the pandemic”

    “We’ve quadrupled our production and added new customers during the pandemic”

    This week, Ilan Avni, Vice President, Business Development, Wavelength Pharmaceuticals is back on SpeakPharma. He talks about Wavelength’s imminent merger with SEQENS (slated to close later this year), the company’s performance during the pandemic and its various interesting technological capabilities, such as those in enzymatic chemistry, spray drying and particle engineering solutions. In particular, Avni talks about how the merger with SEQENS will make Wavelength a global leader in the API and CDMO space with 22 production sites and 10 R&D centers across the world. Excerpts: — A year back, we had discussed how Wavelength’s investments in its supply chain has helped the company during the pandemic. Where do things stand today? How has the market changed? Reflecting on the past year and the ongoing Covid-19 crisis, I can say with confidence that our many years of investment in supply chain assurance has paid off. Not only have we been able to reliably supply critical drugs to our customers during the global crisis, we were also able to quadruple our production and supply to many additional new customers and territories, where other players did not have the capability to deliver. Times are changing — more and more pharmaceutical manufacturers and governments are coming to the conclusion that reliable supply is a critical investment for long-term sustainable growth. — How is Wavelength’s merger with SEQENS (slated to close later this year) likely to benefit the company? Do you expect Wavelength’s global standing and market share in the API CDMO space to improve considerably? We are extremely excited about the upcoming merger with SEQENS. We share the same values, focus on quality, regulatory compliance, and exceptional customer service. The merger will create a global leader in the API and CDMO space with 22 production sites and 10 R&D centers across the world, and a backward-integrated leader offering a broader portfolio of generic APIs and intermediates as well as custom development and manufacturing services across a wide range of added complementary pharmaceutical technologies.    — Wavelength has some interesting technologies. What capabilities have you developed in enzymatic chemistry? And what is Wavelength’s strength in this field? Enzymatic chemistry is an incredibly powerful tool for organic synthesis. It increases conversion efficiency for significantly higher yields with fewer by-products, equating to faster and more cost-effective production. This is largely due to its superior enantio-, regio-, and stereoselectivity under milder conditions, compared to using conventional metal catalysts. We have recently completed validation of a new commercial scale enzymatic process for a leading high-volume type 2 diabetes product with results by far superior to any other process in the market. Our customers are getting ready for commercial launch, and we are confident our product is going to provide them with a game changing advantage in this highly competitive market.   We already have several additional products in our pipeline developed using enzymatic chemistry and I believe that with SEQENS’ expertise in developing new tailor-made enzymes and with Wavelength’s expertise in scaling up such processes, we are going to see many more of these products in the market in the very near future. — Tell us about Wavelength’s strength in spray drying. How have customers benefitted from your capabilities? Low aqueous solubility of APIs often translates into poor bioavailability that can be a cause of failure during drug development. As such, improved aqueous solubility is a primary objective of formulation development, especially for oral, inhaled, and topical drugs. The number of poorly soluble small molecule drugs has significantly increased over the years and the demand for spray drying capacity is on the rise. Production slots are booked well in advance, creating bottlenecks that threaten to prolong time-to-market. Wavelength has more than 30 years of proven track record in spray drying and we continue to invest in particle engineering technologies, including current and next-generation spray drying technologies to address solubility and bioavailability challenges for a broad range of therapeutics. We believe this is one of the advanced skills an experienced API CDMO should be able to offer to its customers, especially those looking to develop BCS Class 2 (low solubility and high permeability) and BCS Class 4 (low solubility and low permeability) drugs. — What additional particle engineering solutions have you developed and how is Wavelength using these technologies to solve drug design challenges? We have in-house expertise in various micronization techniques, both for high volume APIs as well as corticosteroids and other highly potent APIs up to OEB5 (OEL<1 μg/m3). Our unique micronization equipment can reduce particle size from 5mm to <5μm in a single pass using ultra-low energy technology with minimum mechanical or heat impact. Therefore, there is no impact on crystalline properties or increase in amorphous content, which is a huge advantage.  Wavelength has been supplying various inhalation grade APIs for dry powder inhalers and metered dose nasals for more than 20 years now and many of our customers have selected Wavelength for particle design expertise, although they have the same API produced in-house.   — Are there any new technologies you are looking to implement in the near future? Our CDMO business is expanding very rapidly. We continue to focus on complex chemistry and are moving into GMP production of oligonucleotides. We see more and more therapeutic oligonucleotides reaching the market, offering effective treatment to many unmet needs.  These are quite large and extremely complex molecules, though still considered “small molecules” from a regulatory perspective. Processes include multiple synthesis steps, protection, cleavage and de-protection, purification, ultrafiltration and lyophilization, which are very much aligned with our manufacturing track record and also a perfect match with our complex analytics expertise. We already have six novel oligonucleotides being tech transferred to commercial scale GMP production, so we are extremely excited about this new field and are looking forward to further expand production capacity to support our customers’ demand. .  

    Impressions: 1150

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    https://www.pharmacompass.com/speak-pharma/we-ve-quadrupled-our-production-and-added-new-customers-during-the-pandemic-speakpharma-with-wavelength-pharmaceuticals

    #SpeakPharma With Wavelength Pharmaceuticals
    26 Oct 2021
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    “Wavelength’s strategy to continuously invest in its supply chain has proven itself during the Covid-19 pandemic”

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

    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.  

    Impressions: 4069

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    https://www.pharmacompass.com/speak-pharma/wavelength-s-strategy-to-continuously-invest-in-its-supply-chain-has-proven-itself-during-the-covid-19-pandemic-speakpharma-with-wavelength-pharmaceuticals

    #SpeakPharma With Wavelength Pharmaceuticals
    06 Aug 2020
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