HTL Biotechnology DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

HTL Biotechnology got the new certification ISO 13485

24 Jan 2025

// PRESS RELEASE

HTL Biotech Release of our first CSR Report!

10 Jan 2025

// PRESS RELEASE

New Certification for HTL Biotechnology

01 Oct 2024

// PRESS RELEASE

DATA COMPILATION
#PharmaFlow

Contact Supplier

Website

CPhI Korea

Exhibiting

Book a meeting

envelop Contact Supplier

DIGITAL CONTENT

1 Interview #SpeakPharma, 12 Corporate Content #SupplierSpotlight, 22 News #PharmaBuzz

media
1 Interview #SpeakPharma
12 Corporate Content #SupplierSpotlight
22 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

7 All APIs, 3 USDMF, 4 CEP/COS, 2 JDMF, 6 KDMF, 2 NDC API, 3 Listed APIs

7 All APIs
3 USDMF
4 CEP/COS
2 JDMF
6 KDMF
2 NDC API
3 Listed APIs

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

KEY PRODUCTS

Hyaluronic Acid, Sodium DNA, Sodium Hyaluronate

Hyaluronic Acid
Sodium DNA
Sodium Hyaluronate

SERVICES

API Manufacturing

pharmaServices
API Manufacturing
- 1 Biopolymers

KEY SERVICES

Functionalized Biopolymers Services

Functionalized Biopolymers Services

INSPECTIONS & REGISTRATIONS

7 FDA, 8 EDQM

inspections
7 FDA
8 EDQM

HTL Biotechnology is a French biotech & a global leader in the responsible development & production of pharma-grade biopolymers.

About

HTL is a biotechnology company pioneering the development and production of pharmaceutical-grade Hyaluronic Acid (Sodium Hyaluronate) and other functional biopolymers such as PDRN and PN, designed to improve people's lives. HTL is the only Hyaluronic Acid producer exclusively producing injectable grade. Our premium quality biopolymers are used by healthcare companies for the development of treatments in various cutting-edge therapeutic areas such as ophthalmology, dermatology, medical aesthetics and rheumatology.

CPhI North America CPhI North America

Industry Trade Show

Not Confirmed

20-22 May, 2025

Pennsylvania Conv Center, Philadelphia
CPhI KoreaCPhI Korea

Industry Trade Show

Exhibiting

26-28 August, 2025

COEX, Seoul, Korea
STLE Annual MeetingSTLE Annual Meeting

Industry Trade Show

Not Confirmed

18-22 May, 2025

Atlanta, Georgia

CONTACT DETAILS

Click the arrow to open the dropdown

Country

France

Address

7 Rue Alfred Kastler - ZI de l’Aumaillerie 35133 Javene

Telephone

+33 0299993737

contact@htlbiotech.com

Website

https://htlbiotech.com/

https://www.linkedin.com/company/htl-biotechnology/

YouTube

https://www.youtube.com/@htl7143/videos

Digital content

Explore the latest content creation from this company

INTERVIEW #SpeakPharma

“Through innovation, we’ve emerged as world leaders in biopolymers”

This week, SpeakPharma interviews Anne-Laure Gaudry, Head of Innovation and R&D at HTL Biotechnology, a global producer and developer of pharmaceutical-grade biopolymers. Anne-Laure Gaudry discusses the story of HTL Biotechnology, the evolution of the biopolymer market, and HTL’s innovation and R&D strategy. 🔑 HIGHLIGHTS// pharmaceutical-grade biopolymers/ CDMO Can you briefly take us through the history of HTL Biotechnology? From the very beginning, HTL Biotechnology distinguished itself from the rest through its bacterial fermentation manufacturing method, as also its hyaluronic acid produced in fiber form. These are proof of our uniqueness, very high product quality, experience and the unique know-how of our teams. For over 30 years, HTL Biotechnology has been producing hyaluronic acid (HA) for some of the biggest names in the pharmaceutical industry. World-renowned expertise and unwavering commitment of HTL Biotechnology’s teams has helped the company grow significantly over the years. Since 2003, HTL Biotechnology has embarked on a process of improving its manufacturing facilities and final purification stages. This has significantly increased the purity of the pharmaceutical grade HA that we produce. To consolidate the laboratory’s lead in the market in terms of product quality, HTL Biotechnology invested heavily in training, quality control and better equipment. In 2014, to keep pace with demand and to ensure HTL Biotechnology’s long-term growth, the Javené site (Brittany, France) was considerably expanded. At the same time, HTL Biotechnology continued to strengthen its teams, infrastructure, and equipment, notably through the acquisition of new fermenters with greater capacities. Over the years, HTL Biotechnology has become the world leader in pharmaceutical grade biopolymers and a unique force in innovation. To bring innovation for its customers in historical applications (aesthetics, rheumatology, ophthalmology) and to pave the way in new therapeutic applications (drug delivery, regenerative medicine, microneedling, ocular drug delivery and bioprinting), HTL Biotechnology decided to invest in the construction of an R&D laboratory, called HTL3, in Javené, France. Inaugurated in 2018, this state-of-the-art laboratory symbolizes the company’s R&D ambitions, to push the boundaries of the use of HA to meet unmet medical needs. 🔑 HIGHLIGHTS// manufacturing HA for 30 years/ hyaluronic acid in fiber form/ Javené site expansion/ regenerative medicine, microneedling, ocular drug delivery and bioprinting How has the market for biopolymers evolved over the years? As the world became more aware of the environment and began moving towards sustainability, the demand for biopolymers increased. In the pharma sector, biopolymers began to see substantial use in drug delivery methods to finetune efficacy. Biopolymers are an important class of materials because of their biodegradability — they work well with the body, are safe, don’t trigger immune responses, stay in the bloodstream for a long time, and can carry a high amount of both large and small drug molecules. The quality of hyaluronic acid has always been a priority for HTL. The first few years of our activity in biotechnology — i.e. between 1992 and 1998 — were a period of finetuning the methods for producing HA by bacterial fermentation, in order to find the parameters that would ensure the best possible quality for use by the pharmaceutical industry. Since then, HTL Biotechnology’s quality teams have set up a quality management system. Today, we are ISO 14001 certified. Over the past few decades, various methods and procedures for producing biomaterials have emerged that aim to understand and replicate the crucial structural and compositional features of natural tissues. We’ve been using bacterial fermentation to produce HA since the early 1990s and are one of the most experienced companies in this space. Today, raw materials of animal origin are no longer needed to produce HA, thereby preserving natural resources. Over the last few decades, our HA has changed the lives of millions of people around the world. 🔑 HIGHLIGHTS// DDS/ biodegradability/ don’t trigger immune response In 2021, the company opened a new bioproduction unit in France. Tell us how the market for HA is growing, and how the new unit has contributed to growth. We have unparalleled expertise in producing premium quality HA. We had been experiencing double-digit growth and international expansion prior to setting up of the new bioproduction unit in France. Therefore, we strategically made the largest investment ever for a biopolymer production unit. The over €50 million (US$ 53.52 million) investment in HTL4 signifies the culmination of HTL Biotechnology’s biomanufacturing expertise, setting a new standard for innovation and infrastructure quality. Cutting-edge technologies at the plant enable production lines to be automated and digitized, guaranteeing historic quality of production. From the outset, we took a strategic decision to reduce the environmental impact of our activities while guaranteeing reliability. This unit has more than doubled our production capacity, allowed us to accelerate international development and emerge as the world’s largest producer of pharmaceutical-grade HA. Finally, HTL4 has secured the supply of our customers in over 30 countries and helped many leading pharma companies offer innovative therapeutic solutions to their patients worldwide. 🔑 HIGHLIGHTS// double-digit growth/customers in over 30 countries/ €50 million investment HTL Biotechnology also has a 45-year track record in producing DNAs. Which applications require DNAs? And what goes behind DNA production? We are identified with our quality, safety and efficacy. The market has recognized us for being able to provide pharmaceutical-grade DNA for both topical and injectable applications, with a high level of purity, biocompatibility and efficacy, owing to our gentle production process designed to protect the double-strand structure of a DNA. All our products are GMP compliant. Polynucleotides have pharmaceutical uses in aesthetics. They help increase collagen production in the skin and maintain its elasticity. Polynucleotides also promote fibroblasts proliferation that are essential for wound healing. PDRN is a drug used to reduce inflammation caused by UVA and UVB, and it also reduces oxidative stress in cells. We also produce sodium DNA, our cosmetic grade DNA used in products like regenerating mask, serum, cream and repairing cream. 🔑 HIGHLIGHTS// topical and injectable applications/ high level of purity/ help increase collagen production in skin and maintain its elasticity What are some of the objectives of your R&D strategy? Innovation is at the heart of our strategy. Our specialist teams work seamlessly to drive innovation. We believe biopolymers are central to tomorrow’s therapeutic innovations and have the potential for infinite applications in many therapeutic areas. Our strategy is to innovate for the benefit of our customers and their patients through the development of increasingly avant-garde and high-performance biopolymer platforms. Today, HTL Biotechnology produces over a hundred ‘custom-made’ HAs for its customers. We have developed several new products, such as silanized HA and methacrylate HA. With chemical functionalization, new properties and characteristics can be added to the polymer. HTL Biotechnology’s functionalized biopolymers business enables the development of tailor-made products that can be manufactured on an exclusive basis, from process development to GMP production. These processes can be used to create the HAs of tomorrow. 🔑 HIGHLIGHTS// development of increasingly avant-garde and high-performance biopolymer platforms What are some of the new growth areas HTL Biotechnology is looking at ? There are some very exciting possibilities for HA in a few rapidly developing technologies like bioprinting and microneedle patches. Today, one million people in the world are awaiting transplants. Can you imagine the possibility of creating organs? Bioprinting is the biological equivalent of 3D printing. HA is one of the substances used for bioprinting. The technology allows us to imagine a fantastic area for expansion. Moreover, we are looking at intradermal vaccine delivery, thanks to dissolvable needles that are barely visible to the naked eye and are made of HA. We are also working on innovation in other areas such as oncology, rheumatology and odontology. 🔑 HIGHLIGHTS// possibility of creating organs?/ 3D printing/ intradermal vaccine delivery/ Over the last few years, HTL Biotechnology has set up an affiliate in Asia. How have these affiliates contributed to the growth of HTL Biotechnology? In 2022, we established an Asian subsidiary, and this can be seen as a mark of the company’s ongoing global expansion and dedication to serving healthcare customers across all Asian countries. Operating from Singapore, HTL Biotechnology Asia will bring the company closer to its clients and ensure unparalleled support. Also, our teams in Korea and China are focused on engaging with our existing clients, forging new business relationships, and exploring opportunities for expanding our market presence in these regions. 🔑 HIGHLIGHTS// Asian subsidiary, in Singapore What are the company’s long-term growth plans? Are you looking at expanding your global presence? Our story has only just begun. By 2030, we expect our innovative biopolymer platform to benefit over 500 million patients worldwide suffering from ocular, rheumatological, aging diseases and other diseases with the development of new applications. Our future involves a global expansion, from the United States to Asia, with stronger teams in France, an ever-increasing number of applications for our biopolymers, and the constant creation of new and innovative biopolymers, thanks to our R&D investments. We look at HTL Biotechnology as a global company with a heart in Brittany, France. 🔑 HIGHLIGHTS// 500 million patients/ ocular, rheumatological and aging diseases/ global expansion to the US and Asia/

Impressions: 1660