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Adjuvants are chemical or biological products that make vaccines more effective and efficient. When included in a vaccine, an adjuvant will stimulate the recipient’s immune system to generate antibodies or induce cell-mediated immunity against the simultaneously administered antigen.

Production Distribution

Around the world, medicinal products are manufactured using different standards called “good manufacturing practices” (GMP). Some countries have their own GMPs and their own regulatory agencies; the EU shares one common standard. In the United States, not all adjuvants fall in the category of medicinal products that must comply with GMP standards. In these cases, the manufacturer blends an antigen produced under GMP with an adjuvant produced without any standards, thus potentially decreasing the product’s overall quality. What is more, under GMP, there is also a focus on preventing cross contamination of a product from supplier to customer.

Due to these inconsistent manufacturing standards, the quality of adjuvants produced and distributed in the United States varies.

Proposed Changes for Consideration

In order to ensure proper safety, the USDA should consider:

* Requiring animal vaccine related adjuvants to be manufactured in accordance with GMPs

* Classifying animal vaccine related adjuvants as Active Pharmaceutical Ingredients (APIs), as the impact of the antigen on the immune response depends on the adjuvant

* Regulating animal vaccine related adjuvants like other active ingredient in a pharmaceutical product

Making these changes would ensure that the same quality of adjuvant is used in the production of veterinary and human vaccines. A population’s overall health is, after all, based on many factors, including the people with whom we interact (herd immunity), the animal-based products we consume, our co-existence with domestic pets in the home (zoonotic considerations), and our exposure to pathogens.

Combating cross contamination and emphasizing product purity from supplier to customer would enhance safety in each of these areas. Prophylactic vaccines in which adjuvants are used are intended for healthy individuals, necessitating the highest possible standards in order to prevent needless side effects and ensure the end product functions as intended.

About Brenntag

Brenntag Biosector, a division of Brenntag Group based in Denmark, is the leading global vaccine adjuvant manufacturer. The company manufactures its adjuvants in accordance with Denmark’s GMP (which is based on EU GMP Vol. 4 Part 1).

Brenntag’s manufacturing process is managed and monitored from supplier to customer, with all suppliers (of ingredients, packaging, and lab services) fully audited, and personnel trained to work according to pharmacological standards. Another of Brenntag’s unique features is the full traceability of all raw materials used in the product. The manufacturing process also uses heat (autoclavation) instead of electron beam irradiation to sterilize the adjuvants.

Brenntag Biosector meets the standards in some – but not all – of the proposed reforms. The company wishes to assist the U.S. federal government in better understanding the benefits of an enhanced regulatory approach for adjuvants.

Brenntag is committed to a level playing field on which all manufacturers follow one set of rules. In contrast, the lack of a regulatory framework for operations makes obtaining funding for investments and research difficult.