Biologics Firm Receives FDA Warning Letter
Envita Natural Centers of America (Scottsdale, AZ, www.behealthyamerica.com) received a warning letter from the FDA on June 14 that states that the firm's manufacturing process violates the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.
Envita Natural Centers of America (Scottsdale, AZ, www.behealthyamerica.com) received a warning letter from the FDA on June 14 that states that the firm’s manufacturing process violates the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.
Envita produces cancer treatments by extracting cells from cancer patients and manipulating them to increase the T-cell count, with the aim of enabling the body to kill off tumor cells. Based on an inspection conducted March 1, 2006, FDA concluded that the company’s process rises above the agency’s threshold of “minimum manipulation” of cells.
According to the warning letter, Envita’s treated cell cultures are both a biological product and a drug, for which the company must have a valid biologics license (BLA) or new drug application (NDA) in effect before commercial distribution. Prior to approval, biological and drug products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect. Envita does not have an IND in effect for this product, and neither a BLA nor an NDA has been filed.
The agency says that the company’s treated cell cultures do not meet the definition of human cells, tissues, and cellular- and tissue-based products (HCT/Ps). Under 21 CFR Part 1271, HCT/Ps are not subject to license or IND requirements if certain criteria are met. In this case, says the agency, those conditions are not met because the cells are more than minimally manipulated.
The warning letter also says Envita violated regulations governing the proper conduct of clinical studies by failing to submit an IND and to meet the general requirements of an IND.
In addition, FDA says Envita’s product appears to be misbranded within the parameters set by the Food, Drug & Cosmetic Act because the labeling fails to clearly state adequate directions for the drug’s intended use.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Kyron.bio Raises €5.5M to Advance Precision Glycan Engineering for Safer Antibody Therapeutics
May 28th 2025Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.
