Good Manufacturing Practice (GMP): What it means, why it matters

America celebrated her 250^th anniversary of independence this year. As Hope Bio marked the occasion with family, friends, and community, the flags waving and fireworks in the air served as a reminder of how grateful we are to be in America (specifically in Texas, and in Sugar Land (west of Houston), but more on that in future discussions).

Pride in the red, white, and blue is more than emotive sentiment. Cellular therapeutics are produced all over the world, but headquartering in the United States (U.S.) profoundly shapes how Hope Bio contributes to healthcare and pushes science forward for communal benefit. The decision to make treatments exclusively in America, for access in America, according to U.S regulatory standards, is a deliberate one with specific and lasting effects for healthcare technologies you may one day access. Let’s talk about it:

Manufacturing Standards

Ever come across a video, podcast, or well-meaning friend who tells you that your personal life will improve when you get some standards? Whether the sentiment pertains to dating, fitness, or anything else, well…. Manufacturing is like that, too.

Manufacturing is better (safer, cleaner, more responsible) with standards. In the U.S., those standards are called “Good Manufacturing Practice” (GMP). Sometimes patients, families, and community members express surprise when they visit Hope Bio’s labs and realize that production of a leading-edge biotechnology is in a foundational sense the same as producing anything else – there are physical spaces that must be established and upkept, equipment to be maintained, processes to be in put in place and upheld, personnel standards to institute and enforce. Specifically challenging in biomanufacturing, which can involve variable or individualized production, are considerations such as product safety, identity, and quality. Even more specialized to cell therapies are product consistency and potency when the treatment is administered to patients, which can sometimes be a complex process involving academic, hospital, or other research partner organizations and an array of variables that must be controlled for.

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Optimal standards in each operating area of a manufacturing business are enforced through regulation. In drug production in the U.S., such regulation is the realm of the Food and Drug Administration (FDA). The FDA’s Center for Biologics Evaluation and Research (CBER) oversees biologics-specific compliance, with an eye toward both regulatory objectives and adherence to a quality assurance framework. Specialized guidance exists for cell and gene therapies, including of the type manufactured at Hope Biosciences. The phrase “21 CFR” can be commonly thrown around in biologics-related circles; it is shorthand for “Code of Federal Regulations Title 21,” the portion of the federal regulations that interprets the Federal Food, Drug and Cosmetic Act and related statutes. Though Europe and Asia have their own regulatory standards, and foreign companies who want to do business in the U.S. often adhere to GMP, the U.S. standard is the most mature, well-articulated, and arguably the most well enforced.

GMP certification exists in a continuum of quality standards from bench to bedside; that is, in the process of getting a drug or technology from a laboratory bench and bedside, to a person in need. Good Laboratory Practice (GLP) governs early work, GMP is the realm of manufacturing, and Good Clinical Practice (GCP) mandates requirements for clinical research and treating patients. GMP assessment is lengthy, specialized, and multi-process. The total undertaking can be up to eighteen months for a new biologics facility, and as many as six months for an existing facility undergoing change. On-site inspection by regulators can range from one- to four- weeks.

Thinking of GMP as a “certification” is a bit misleading. Though commonly used terminology, GMP is not a static accreditation, and no true certificate is ever awarded. Rather, GMP validation is a continual process that requires regular reassessment, including on-going on-site inspections by CBER and the FDA’s Office of Inspections and Investigations (formerly structured as the Office of Regulatory Affairs (ORA)). The dynamic, ongoing nature acknowledges that regulatory expectations for biologics are constantly evolving, not only as the drugs themselves push technology forward, but also in areas such as data integrity and digital records. GMP compliance requires ongoing adaptation and demonstrated capacity to maintain high, consistent standards at all times, including in the face of industry change.

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The 1938 Federal Food, Drug, and Cosmetic Act made GMP a legal requirement to produce regulated products, such as biologics. Failure to comply with GMP requirements carries potentially profound implications not only for the people who will eventually use a manufacturer’s product, but for the viability of the business. Building labs, training personnel, maintaining equipment, and all the other considerations required of GMP can be expensive, and there may be manufacturers who simply forego certification from the beginning. More common, however, are manufacturers who fail to maintain the GMP standard once accredited. In either case, consumers are wise to complete due diligence on the company whose products they consider accessing, and dive deep into any instance of noncompliance.

At Hope Bio, all procedures are performed in compliance with current GMP and current GLP regulations. All processing for stem cell banking and therapeutic manufacturing takes place in ISO 7 and 8 cleanrooms designed, certified and monitored in accordance with ISO 14644-1 & 14644-2 standards. Hope Bio’s quality management system operates in accordance with ISO 9001:2015.

Why stem cell banking services matter to access

High manufacturing standards are vital to patient safety, but upholding them undeniably slows production and raises costs, compared to theoretical production models in which no such regulation was in place. As interest in cellular therapeutics has grown in many facets of science and the general public, the manufacturing industry has struggled to meet demand. Additional gaps in time, money, and sometimes quality exist between entities that harvest and preserve stem cells, and companies that manufacture therapeutics from those cells. In a foundational sense, no matter how top-tier the manufacturer, they can only create a product as effective as their raw materials. How cells are banked, matters.

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Addressing these voids in the cellular therapeutics chain is precisely how Hope Biosciences entered into stem cell banking. Hope Biosciences began offering stem cell banking services to adults and newborns as a direct response to manufacturing bottlenecks that slow technology delivery to people in need and inhibit scalability. Banking stem cells at the same place technology is manufactured from those cells dramatically increases efficiency, reducing costs and slashing manufacturing timelines, while ensuring the highest levels of quality in all stages of production and quality assurance.

When Hope Biosciences is proclaimed “the only clinical-grade banking service for adults and newborns in the U.S.,” that means that Hope Bio is the only GMP-compliant company offering services to both populations. Now, you know more about what that means, and why it matters to you. It remains Hope’s privilege to serve.