Gattefossé is a key provider of specialty excipients and drug delivery solutions based on lipid chemistry, transforming naturally occurring raw materials like vegetable oils into sophisticated, well-defined, fully characterized, safe, and functional ingredients. These include highly purified glycerides, polyoxylglycerides, and polyglyceryl esters of fatty acids.
Founded in France and privately held since 1880, Gattefossé is a committed and fully vested partner to health care industries worldwide. The culture of the company remains true to its founders’ deep values and beliefs, which are the pillars of its business model.
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These include knowledge sharing, collaboration toward innovation, quality, sustainability, and excellence in customer service. With offices around the world to service its growing customer base, Gattefossé continues to add to its manufacturing, R&D, and applied research capabilities, and has recently opened its fourth Technical Center of Excellence, located in Paramus, New Jersey.
Dedication to Excipients
Gattefossé’s lipid-derived products include lubricants for tablets; sustained/controlled release matrix formers; solubility and bioavailability enhancers; protective coatings or taste masking agents for actives; enhancers for skin penetration and permeation; emulsifiers for creams, lotions, and ointments; and carriers for suppository and vaginal pessaries.
Ron Permutt, Gattefossé USA’s Senior Director, Pharmaceutical Division, explains how the company became the world’s leading supplier and innovator of lipid-derived products: “Why lipids? That’s our history which goes back to France in 1880 in aromatherapy operations. The company had technology that revolutionized the extraction of lavender oil, enabling its incorporation into medicinal preparations. At the time there was no cosmetic-pharma industry—it was a brand new field.”
Permutt continues, “We started out with the extraction process. Through extraction one obtains natural oily based materials - and it grew from there into personal care and pharmaceutical products. That’s why lipids are really our history and our stronghold in both industries.”
Currently Gattefossé offers hundreds of products for pharmaceutical applications such as the Gelucire®, Labrasol®, and Suppocire® lines. The company also offers other products like diethylene glycol monoethylether, highly purified to meet pharmaceutical standards. Along with providing exceptional excipients to the market, Gattefossé prides itself on offering superior support for its products.
It includes characterization, purity, quality, safety, and regulatory aspects, notably conforming to compendia in the USA, Europe, Japan and China. Equally important, Gattefossé supports its clients in all aspects of drug development – from early screening to late stage phase IV clinical. Gattefossé’s Technical Centers of Excellence located in France, India, China, and as mentioned above the new Technical Center in Paramus, NJ, provide formulation design and development support, which is much needed to advance customer projects and drug pipelines.
Formulation Expertise
As the pharmaceutical industry struggles to bring new products to market, innovator companies are looking for suppliers to help them counter an increasing number of product development hurdles. These challenges include drug molecules with poor solubility, burgeoning molecular sizes, and poor oral absorption properties. These factors are driving the need for high quality excipients with well-defined attributes. As the regulatory pathway for new excipients has become increasingly challenging, Gattefossé has concentrated its expertise on novel uses for existing excipients, new formulation and/or processing technologies, and/or alternative routes of administration.
Further, there is now the collective affirmation that excipients are not always inert or inactive. Combined, these developments have given Gattefossé the opportunity to show the industry its expertise in defining, characterizing, and better understanding the role of each excipient; exploring new combinations of excipients; and using new processing technologies for the development of appropriate drug delivery systems.
Inayet Ellis, Gattefossé USA’s Scientific Affairs Manager, Pharmaceutical Division, explains how the company works with innovator companies who might have a difficult compound. “When it comes to innovator companies, like the oral delivery companies especially, they approach us because they have poorly soluble or poorly available compounds.”
Ellis continues, “From early discovery through final phases of development, we offer support at every step including regulatory filing support for products manufactured for US and global use.”
Speaking to the issue of meeting global regulatory requirements, Ellis offers, “we are a multinational company so we align ourselves well with those who require global support for their filings. Our experts actively contribute to the development of monographs and ongoing discussions on global harmonization of excipient monographs. This not only paves the path for us but more importantly, for our clients; allowing them to innovate and develop products using excipients that uniformly comply with US, European and Asian compendia requirements.”
Technical Centers Of Excellence
The newest Technical Center of Excellence in Paramus, NJ, brings together pharmaceutical and personal care application laboratories in a 5,300 ft² (492 m²) space with state-of-the-art equipment. This enables Gattefossé and its technical team to offer an essential interface with both pharmaceutical and personal care customers throughout North America by providing formulation troubleshooting, inspiration, and technical support. For pharmaceuticals, high priority is given to oral bioavailability enhancement and formulation applications as well as (trans)dermal formulation development.
In the 30’s, Gattefossé established its first R&D and applications laboratories at its French headquarters. Since then, three new Technical Centers of Excellence were opened in key pharmaceutical markets:
Shanghai, China (2007)
Mumbai, India (2008)
Paramus, New Jersey (2017)
The main objectives of these centers are to:
- provide customer technical support;
- characterize and optimize the performance of excipients in drug delivery systems and processes;
- share knowledge through education and training.
The Gattefossé Technical Centers affirm the company’s position and values by:
- Being a committed and fully vested excipient manufacturer actively involved with pharmaceutical development
- Providing evidence for excipient functionality, safety, quality, and regulatory acceptance
- Offering a dedicated technical team to guide and support clients throughout the development cycle, including analytical, preclinical, stability, and formulation characterization
- Providing assistance for regulatory filings in other countries; quality by design initiatives; and flexibility of supply
- Demonstrating reliable and ethical manufacturing practices
Business Strategy – Looking Forward
With a worldwide presence and four Technical Centers of Excellence, Gattefossé is poised to grow its business.
Eric Brun, Ph.D., Gattefossé USA’s President and CEO, attributes the company’s current position in the market and future success to two main pillars: innovation and geographical expansion. Brun explains, “Innovation, why? Because our customers, whether they are in pharmaceuticals or cosmetics, are always looking for new things. In pharmaceuticals, that could be a new delivery/drug release mechanism, or a new technology.”
“In pharmaceuticals, innovation often means different, because the industry is cautious against ‘novelty’ and potential safety risks. Companies are always concerned with new products and ask: Will they be well tolerated? Will you have a good batch to batch reproducibility? Is it safe? Is it efficient? Therefore, innovation in pharmaceutical excipients is less about new excipients than about new applications and improved formulations. At Gattefossé, we invest a lot in areas such as bioavailability improvement and modified release.”
Brun continues, “The second pillar of our success is geographical expansion. Over the past 10 years, we opened Gattefossé in India, China, and Singapore for the Asia-Pacific area; we opened Gattefossé in Tunisia to cover the North African and Middle Eastern markets; there is also Gattefossé Brazil to coordinate activities in South America.”
“We are a mid-sized company, but becoming a global player is essential for us to grow and thrive. But geographical expansion does not mean moving away from our base. It means to be closer to our customers”.
“At Gattefossé, we say ‘People Make Our Name’. Our personnel are highly dedicated experts who work with the customer to solve their formulation and technical issues. With the incorporation of our Technical Centers of Excellence, we bring expertise wherever it is needed so customers can innovate and bring new solutions to the market.”
Laboratory Capabilities
The Technical Center of Excellence is a full service laboratory dedicated to the development of oral, injectable, topical, and transdermal formulations focusing on lipid-based solutions. Our capabilities range from solubility screening to formulation design and characterization.
Below is a short list of support services offered:
- Drug solubility screening in liquid and solid excipients
- Excipient compatibility testing
- Formulation design and optimization for oral bioavailability enhancement
- Conventional dissolution testing
- Dissolution in digestion and biorelevant media for oral delivery
- Particle size measurement of micellar, self-micro emulsifying, and microemulsion dispersions
- Analytical and physico-chemical characterization
- Topical formulation development
- Penetration / permeation (diffusion) testing of topical formulations
- Characterization of topical formulations
- Thermo-rheological testing and characterization
- Hot stage microscopy, imaging and particle sizing
- Physical, chemical, and oxidative stability testing/optimization
- Processing capabilities include milling, mixing, hot melt extrusion and melt granulation
Gattefossé S.A.S.
36 Chemin de Genas CS 70070 - 69804
Saint-Priest Cedex
FRANCE
+33 4 72 22 98 00
www.gattefosse.com
Gattefossé USA
Plaza I, 115 West Century Road, Suite 340
Paramus, NJ
USA, 07652
Tel: +1 201 265 4800
[email protected]