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PharmaCompass
2020-01-01
Impressions: 43
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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