HTL Biotechnology’s Premium Services: A Trusted Partner in Innovation

Innovation in biopolymers today requires the convergence of scientific expertise, advanced technologies, and a clear regulatory pathway. At HTL Biotechnology, this understanding has shaped our Premium Services, a suite of research and regulatory capabilities designed to support our partners throughout different stages of their projects.

More than a supplier of premium quality, pharmaceutical-grade biopolymers, HTL Biotechnology acts as a collaborative partner, helping innovators turn promising concepts into viable solutions for unmet medical needs.

Innovation support: Shaping Biopolymers for Tomorrow’s Therapies

Developing new biopolymer-based solutions often requires both technical expertise and a robust environment for the development of these solutions.

Our Innovation Support provides this framework, offering:

• Expertise in biopolymers with a customized, co-development approach

With more than 30 years of experience, our expertise in the development and production of biopolymers is recognized by leading pharmaceutical companies, as well as by key opinion leaders worldwide. Beyond our expertise, we design our innovation strategies to meet specific unmet needs in medical applications, taking you from initial development through to the clinical or commercial phase and beyond of tailor-made biopolymers.

• State-of-the-art infrastructure

Advanced laboratories and research facilities, equipped with state-of-the-art equipment and technologies ensure the highest standards of quality and innovation in every project, whether it’s perfecting the properties of existing biopolymers or paving the way for the development of new ones.

Regulatory Support: Navigating Global Regulatory Landscapes with Confidence

Bringing innovative solutions to market requires navigating diverse and evolving regulatory landscapes. HTL Biotechnology’s Premium Services includes regulatory support designed to help partners progress smoothly and efficiently through:

• Personalized assistance with regulatory affairs on a global level

We have a team of dedicated regulatory professionals with expertise and in-depth knowledge of regulatory affairs on a global and regional level, with a team dedicated specifically to support our customers in Asia.  As every product is unique, our team offers personalized assistance to our customers, adapted to the products and the regulatory standards of the market they operate in.

• Case management support with concerned health authorities

We offer personalized case management support for regulatory file submissions with concerned health authorities, to minimize the risks of refusal or delay. Our aim is to help you get approval quickly and smoothly.

• Regulatory surveillance

Going beyond regulatory approval, we continuously monitor regulatory developments so that we can provide you with post-commercialization support to help you manage any necessary updates.

A Robust Industrial Platform

Behind each innovation supported by HTL Biotechnology lies a robust industrial platform dedicated to the innovation and development, production and quality control of pharmaceutical-grade biopolymers.

At the industrial site in Brittany, France, manufacturing units operate with the highest standards of pharmaceutical quality and are structured to ensure both consistency and quality. The platform integrates:

• Controlled fermentation and purification processes
• Two independent production lines for both hyaluronic acid and polynucleotides
• Ongoing expansions to anticipate future demand

Advancing Therapeutic Innovation Together

Our Premium Services support the development of solutions across multiple biomedical applications, including ophthalmology, aesthetics, rheumatology, and regenerative medicine. Whether through a co-development approach, regulatory support, or industrial reliability, our objective remains consistent:

to help our partners bring safe, effective, and reliable solutions to patients worldwide.

As a trusted partner in innovation, HTL Biotechnology continues to strengthen its capabilities to support the next generation of biopolymer-based technologies, today and in the future.