White Paper

Recombinant Collagen Made Via Fermentation Can Address Key Unmet Market Needs For Safety, Sustainability And Acceptability

By Balaji Prabhu, Director Strategic Marketing for Medical Devices, Evonik Health Care

Evonik

Collagen is one of the most commonly used biomaterials used in across health care due to its excellent biocompatibility, biodegradability, broad application ranges, well-defined structure and how it interacts with cells and tissues. It can be processed directly, or in some cases utilizing additional cross-linking technologies, into a variety of forms such as lyophilized powders, liquid solutions, hydrogels, films or meshes and sponges for use across a wide variety of health care applications.

However, the supply of collagen from traditional animal-based sources has several risks relating to safety, consistent reproducibility, sustainability and consumer acceptability.

Risk of Pathogen and Disease Transmission

Most medical collagen is derived from young cattle that are certified to be free of Bovine Spongiform Encephalopathy (BSE), more commonly known as Mad Cow Disease. The industry continues to express concerns that collagen sourced from cattle, and to a lesser extent pigs, may continue to carry the risk of transmission of BSE or other pathogens and infectious agents that may cause disease.

Risk of Immunogenic or Allergic Reactions

Clinical studies have found that between 2% and 4% of the population is allergic to collagen derived from pork or cows. A similar percentage of people are allergic to seafood. Other studies have shown that collagen from animal sources can evoke both a cellular and immune response in between 3% and 10% of patients. Premature degradation or impaired functionality of medical products utilizing collagen may require the treatment of patients, especially those who are hypersensitive, with immunosuppressants or the use of other non-collagen alternatives.

Sustainable Sourcing

The harvesting of collagen from animal, and to a lesser extent, marine sources, is unsustainable. One industry report recently predicted that the supply of collagen and other related products such as leather from cows may decline by as much as 90% by 2035 if alternative fermentation-based methods can become widely available.

Vegan, Cultural and Religious Acceptability

Around 8% of the world population are either vegetarian or vegan. In the U.S., around 3% of the population are vegetarian and 0.5% vegan. In addition to those who choose not to consume animal-based products for ethical, health or other personal reasons, many people who adhere to religions such as Hinduism, Sikhism and Buddhism may express a preference not to use collagen sourced from traditional sources. Furthermore, pork products are forbidden for consumption by people of Islamic and Jewish faiths. Products sourced from cattle or pork may also need to be kosher and halal certified. The use of medical- or pharmaceutical-grade collagen that is derived from animal sources represents a clear barrier for consumer acceptability and use of products within these life science markets.

Quality Reproducibility

For many medical and pharmaceutical applications, it is critical that collagen can be made in process by which its properties and characteristics and reproducible in every batch to ensure consistent interaction with cells and tissues. The industrial process to extract, sterilize, purify and supply traditional sources of collagen in a reproducible manner is extremely challenging and costly.  Many healthcare companies and regulatory agencies would typically favor a source of collagen than provides batch-to-batch reproducibility. A source of collagen with batch-to-batch reproducibility and consistent quality is one of the key unmet needs for the medical community and regulatory agencies.

Emerging opportunities for recombinant collagen

The production of recombinant collagen made via fermentation-based processes represents a significant opportunity to address these market needs for collagen that is safe, sustainable, reproducible and acceptable to consumers. A few companies to-date have sought to develop such fermentation-based recombinant collagens over the last decade. Some of these collagen products may have limited application opportunities within certain market segments. However, there is currently no known recombinant collagen that satisfies all core requirements for supply to health care customers including a triple helix structure, high solubility, and a high-purity process that is commercially scalable utilizing established fermentation processes.

That is why Evonik has developed a unique collagen platform technology that can address unmet market needs for the use of collagen across health care and other life science applications. The technology platform created by Evonik is devoid of all animal-and human origin materials and features a triple helix structure that enable it to mimic many of the attributes of natural collagen.

Evonik’s collagen is also designed to be highly soluble at physiological pH to make it suitable for enhanced cell interaction and adhesion. It is also designed for use with various cross-linking and technologies so that it can be processed into a variety of forms and shapes that are commonly used within the life sciences industry, such as hydrogels, coatings, and sponges. The fermentation-based process occurs under precisely defined conditions to enable the creation of collagen with a high level of purity that is reproducible at development or commercial scale. This consistent level of reproducibility and efficient scalability is difficult to achieve with other known collagen sources.

For further information about Evonik’s collagen platform or to request a sample, send the Company an email via healthcare@evonik.com

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ii RethinkX Report. Tubb, C and Seba, T. September 2019. Rethinking Food and Agriculture 2020 to 2030.

iii https://en.wikipedia.org/wiki/Vegetarianism_by_country