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    Arkema Grants an Exclusive Technology License to SEQENS to manufacture PEKK

    25 Jun 2024

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    Biophytis Announces Successful Industrial Transfer Of BIO101 Production To Seqens

    12 Jun 2024

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    Pierre Luzeau, Seqens CEO Joins 73 Leaders For European Industrial Deal

    21 Feb 2024

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    Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.

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    INTERVIEW #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. — 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. .  

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    Product List 2024

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    Products Under Development 2023

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    Intermediates Product List 2023

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    GMP Certificate 2022

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    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

    The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   
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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technol