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INTERVIEW #SpeakPharma

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“Over 500 million syringes of our hyaluronic acid have been safely used worldwide”

This week, SpeakPharma interviews Marie-Armelle Floc’h, Chief of Quality and Regulatory Affairs at HTL Biotechnology, a global leader in the development and the manufacturing of pharmaceutical-grade biopolymers headquartered in Javené, Brittany (France). Since 1992, HTL has pioneered the production of hyaluronic acid (HA) through proprietary biofermentation, achieving unmatched purity and consistency for applications in ophthalmology, dermatology and rheumatology. Floc’h highlights how HTL Biotechnology’s compelling portfolio of pharmaceutical-grade biopolymers is built on uncompromising quality standards. These standards have enabled the company to supply biopolymers for over 30 years without a single batch recall, firmly establishing its reputation for reliability and excellence. She also discusses the inauguration of HTL Biotechnology’s new sterile hyaluronic acid production unit — a major milestone that reinforces the company’s leadership in biopolymer manufacturing and enables the development of innovative formulations combining hyaluronic acid with thermo-sensitive active ingredients. This new capability opens the door to advanced biomedical applications where safety, stability and efficacy must be preserved without compromising the integrity of delicate molecules and which requires the highest quality standards. What distinguishes HTL Biotechnology’s biopolymer platforms in the market today? HTL Biotechnology has built its reputation on delivering pharmaceutical‑grade biopolymers (hyaluronic acid, polynucleotides and recombinant collagen) with unmatched purity and consistency. Since its founding in 1992, the company has focused on premium quality positioning. With more than 30 years of experience, HTL Biotechnology guarantees pharmaceutical-grade biopolymers of exceptional purity and exemplary consistency to our clients. We have had no batch recalls in 30 years, a record that underlines the rigor and reliability embedded in our processes. This was made possible by our fully-integrated site in France, where R&D laboratories, GMP manufacturing, quality control, and regulatory expertise are brought together under one roof. Such integration allows us to support our clients seamlessly throughout their product development journey, from early innovation through to global commercialization.Also, the inauguration of our new sterile hyaluronic acid production unit expands the possibilities for our HA to be used in advanced formulations with thermo-sensitive active ingredients, while upholding the uncompromising quality that defines HTL Biotechnology.Our operations are guided by internationally recognized standards, including ISO 13485 certification, which ensures the quality and safety required by medical device manufacturers worldwide.In addition, our Halal certification provides our customers with a significant advantage in accessing and expanding into markets where these requirements are essential for commercialization.Beyond certifications, our commitment to supporting global growth is reflected in the Drug Master Files we maintain across five continents, enabling our clients to accelerate product registration and bring innovative therapies to markets across the world more efficiently. By combining craftsmanship with pharmaceutical rigor, supported by state-of-the-art equipment and advanced bio-production methods, we ensure that every batch produced not only meets the strictest standards, but also delivers the reliability and consistency needed across the entire healthcare ecosystem. HIGHLIGHTS// Biopolymers with unmatched purity/record of no batch recalls/integrated facility in France/operations guided by global standards/new sterile HA unit for advanced formulations Navigating the complex and evolving regulatory frameworks across global markets can be challenging for healthcare companies. Can you tell us more about how HTL Biotechnology supports its partners in this area? Regulatory support is part of our core premium services offer. We provide pharmaceutical regulatory support to ensure products meet the necessary compliance standards, so our partners can focus on their growth. Our dedicated regulatory professionals bring global and regional expertise, with a team specifically supporting customers in Asia. We offer personalized assistance adapted to their products and to the compliance standards of the target market. This includes personalized case-management support for regulatory file submissions with the concerned health authorities to minimize risks of refusal or delay, with the aim of achieving approval quickly and smoothly.Our offer for regulatory support continues beyond approval. We continuously monitor updates to regulations and provide post-commercialization support to our partners to help them manage any necessary regulatory updates.HIGHLIGHTS// Regulatory support offered as premium service/global and regional expertise/personalized case management for faster approvals/continuous regulatory support How does HTL Biotechnology integrate sustainability and corporate responsibility into its operations? Sustainability is embedded in HTL Biotechnology’s strategic vision and day-to-day operations. In 2024, the company renewed its commitment to environmental responsibility by reinforcing its corporate social responsibility (CSR) roadmap. Tangible progress was made across multiple fronts: a 27 percent reduction in greenhouse gas emissions per kilogram of HA produced between 2021 and 2024, and a 34 percent reduction in water consumption per kilogram of HA since 2020. In 2024, we renewed the ISO 14001:2015 certification for its environmental management system, reflecting rigorous audit protocols and continual improvement cycles. All employees have been trained in the ISO 14001-certified environmental management system, and 78 percent of critical suppliers have signed HTL Biotechnology’s Responsible Purchasing Charter.These results reflect HTL Biotechnology’s structured and proactive approach to reducing its environmental footprint while maintaining the highest standards of quality and compliance.HIGHLIGHTS// Sustainability embedded in strategic vision/strong CSR roadmap with measurable progress/reduction in greenhouse gas emissions/responsible sourcing

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VLOG #PharmaReel

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Partnering with nature to grow foundational medicines

This PharmaReel showcases Centrient Pharmaceuticals, a global leader in sustainable enzymatic antibiotics, antifungals and next-gen statins, with integrated capabilities across intermediates, APIs & finished dosages, with a vision to be the leading, diversified partner for generics marketers.

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DATA COMPILATION #PharmaFlow

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CDMO Activity Tracker: Lupin’s CDMO commissions oncology block in India; Cambrex, Axplora, Hovione expand operations

The global contract development and manufacturing organization (CDMO) market has been growing at a healthy compound annual growth rate (CAGR) of 9 percent, and is poised to attain a size of US$ 465.24 billion by 2032 from US$ 255.01 billion in 2025.During the current quarter, the sector has witnessed increase in manufacturing capacities and a rapid expansion in specialized modalities. CDMOs are gearing up for higher growth. The global antibody and antibody-drug conjugate (ADC) CDMO market, for instance, was estimated at US$ 21.1 billion in 2024 and is projected to reach US$ 45.8 billion by 2033, growing at a CAGR of 9.38 percent. Similarly, the peptide and oligonucleotide CDMO market was valued at US$ 2.8 billion in 2024, and is expected to grow at 12.8 percent CAGR, attaining a size of US$ 8.14 billion by 2033.Even though cell and gene therapies (CGTs) have been facing considerable challenges in recent years, the CDMO market for CGTs is estimated to witness a very high growth rate of 27.92 percent CAGR — catapulting it from an estimated US$ 6.31 billion in 2024 to US$ 74.03 billion by 2034. According to a report by Precedence Research, the integration of artificial intelligence in CGT manufacturing is playing an important role in optimizing cell selection, predicting treatment results and analyzing large datasets that help identify potential issues.With the world facing a growing burden of chronic diseases, and the pharmaceutical industry facing a shortage of in-house manufacturing and R&D capabilities, CDMOs in the global small-molecule market are also witnessing high growth. Currently valued at around US$ 78.01 billion, the market for small molecule CDMOs is growing at 7.14 percent CAGR and is expected to reach US$ 145.12 billion by 2034.Some of the key players in the CDMO space include Lonza, Axplora, Mission CDMO, LGM Pharma, Veranova, EUROAPI, Evonik, Thermo Fisher, Lupin Manufacturing Solutions, Bora Pharmaceuticals, Samsung Biologics, and Syngene. View CDMO Activity Tracker for Q4 2025 (Free Excel Available)Lupin Manufacturing Solutions, Serán BioScience, Alcami Simtra expand capacitiesCDMOs across the globe are increasing capacities. Lupin Manufacturing Solutions (LMS), a wholly owned subsidiary of Lupin Limited, commissioned a dedicated oncology Block at its Vizag (India) facility. The high-containment unit enhances LMS’ end-to-end CDMO capabilities for high potent active pharmaceutical ingredients (HPAPIs), supporting oncology programs from preclinical development through commercial manufacturing. American CDMO Serán BioScience completed two of the three new buildings and commenced the construction of a third facility at its new 100,000-square-foot commercial manufacturing campus in Oregon (US). The campus includes a 50,000-square-foot facility dedicated to specialized packaging and supply chain operations.Similarly, Texas-based Mission CDMO has added new large-scale equipment for the production of oral solutions and semi-solids, thereby increasing its annual capacity to 13 million liters.New Jersey-based CDMO Simtra is expanding manufacturing operations in both the US and Germany. In Halle/Westfalen, Germany, Simtra commissioned a conjugation and purification suite and inaugurated a new building equipped with two high-speed isolator lines for syringes and vials. And American CDMO Alcami Corporation has expanded its laboratory services at its Creekstone Drive facility in Durham, North Carolina. View CDMO Activity Tracker for Q4 2025 (Free Excel Available) Cambrex, Axplora, Hovione expand operations; India’s Syngene upgrades its sitesIn other capacity expansion news, US-based CDMO Cambrex has announced a US$ 120 million investment to expand its manufacturing operations in the US. The investment increases the large-scale manufacturing capacity at its Charles City, Iowa site, by 40 percent, taking total capacity close to one million liters.European CDMO Axplora has stated that total investments initiated across its global network in 2025 will exceed €100 million (US$ 117 million). This includes €60 million (US$ 70.4 million) allocated to the ongoing expansion of its Mourenx (France) site, along with €35 million (US$ 41 million) at its Gropello (Italy) facility and €8.5 million (US$ 9.9 million) at its Vizag (India) site, both announced earlier in the year. In addition, Axplora has expanded its ADC manufacturing capabilities at its Le Mans (France) site.India-based Syngene International has announced site upgrades aimed at accelerating drug discovery and development timelines for its clients. The investments include a dedicated peptide laboratory at its Bengaluru site and the introduction of advanced automation across drug metabolism and pharmacokinetics and direct-to-biology workflows in Hyderabad.Portugal-headquartered Hovione has completed an initial US$ 100 million investment cycle to expand its manufacturing site in East Windsor, New Jersey. The expansion supports Hovione’s strategy to grow its US operations and strengthen its integrated capabilities across drug substance, drug product intermediates, and finished drug products. View CDMO Activity Tracker for Q4 2025 (Free Excel Available) Lonza buys microbial testing firm, launches two products for manufacturing CGTsSwiss CDMO Lonza has launched two products — TheraPEAK AmpliCell Cytokines and TheraPEAK 293-GT Medium —to expand its GMP-grade solutions for CGT manufacturing. TheraPEAK products are used in FDA-approved therapies and over 130 clinical trials globally. The expanded portfolio provides scalable, regulatory-ready solutions to support workflows from discovery through clinical development.Lonza has also signed an agreement to acquire Redberry SAS, a France-based microbial testing technology company. The acquisition adds Redberry’s Red One rapid microbial detection platform to Lonza’s portfolio.Separately, Oxford Biomedica has signed and closed an asset purchase agreement to acquire a custom-built viral vector manufacturing facility for CGTs in North Carolina (US) from RTP Operating, LLC, a subsidiary of National Resilience Holdco. OXB paid £3.4 million (US$ 4.5 million) for the assets. View CDMO Activity Tracker for Q4 2025 (Free Excel Available) Bora partners Corealis for oral drugs; Piramal, IntoCell join hands for bioconjugates Bora Pharmaceuticals and Corealis Pharma have entered into a strategic alliance to provide end-to-end services for oral soild dose (OSD) development and manufacturing. The collaboration offers a scalable pathway from early development to commercial production for pharmaceutical and biotech companies.Piramal Pharma Solutions has signed a non-exclusive and non-binding MoU with IntoCell. The collaboration combines IntoCell’s proprietary drug-linker technologies with Piramal’s experience in developing and manufacturing ADCs through its ADCelerate platform.In other deals, UK-based eXmoor Pharma has entered into two collaborations to support the development of CGTs. The first is with University College London’s Translational Research Office, while the second is with Royal Free London NHS Foundation Trust’s Cell and Vector Innovation Centre. View CDMO Activity Tracker for Q4 2025 (Free Excel Available) Our viewThe current spate of investments underscores how the CDMO sector is emerging as a capability-driven ecosystem. While incremental capacity additions continue across small molecules and OSD forms, the sharper strategic focus is clearly on high-growth, high-complexity areas such as ADCs, CGTs, peptides and oligonucleotides.

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NEWS #PharmaBuzz

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Health Canada Issues Recall of AX Pharmaceutical's Diclofenac Sodium Micronized Powder

21 Mar 2023

// HEALTH CANADA

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