Cali OKs Stemedica to manufacture stem cells for trials

By Gareth Macdonald

- Last updated on GMT

Related tags: Stem cells, Stem cell

Stemedica Cell Technologies’ new license to make stem cells for trials positions the firm as a “valuable resource for front line researchers,” according to VP of business development Dave McGuigan.

He told Outsourcing-pharma the license, which was issued by California State authorities, grants Stemedica the right to make any of its 15 stem lines and propriety cell products for pharma and biotechnology clients’ clinical trial applications.

McGuigan explained that potential customers need to provide testing protocols and, in the case of clinical trials, all the necessary regulatory approvals “for the importation and clinical use of allogeneically-based adult stem cells​.”

He added that: “We’re seeing a growing interest in the value proposition that stem cells and stem cell factors are bringing to the pharmaceutical and biotech business model.

From using stem cells to create new drug compounds to incorporating [them] into treatment regimens where the dosage level of an otherwise toxic drug can be reduced to tolerable levels, stem cells can play a myriad of roles in the future of the biotech and pharmaceutical industry​.”

However, despite the growth in demand and the obvious potential of stem cells in preclinical development and clinical trials, to date, very few contract manufacturing organizations (CMO) have started offering this type of service.

McGugan said that, to the best of his knowledge, less than six other companies worldwide have been cleared to make clinical grade stem cells and, he continued, none of these have Stemedica’s level of manufacturing experience.

Manufacturing stem cells isn’t the hard part of the technical exercise. Manufacturing stem cells that migrate, engraft and provide action potential in a clinical setting is what will allow companies like Stemedica to stand out.”

Less stigma after removal of US research ban

The US stem cell sector has been the subject of considerable media and public attention this year, primarily as a result of the Obama Administration’s decision to overturn the ban on embryonic stem cell research.

While Stemedica’s focus on allogenic stem cells meant that law change had little impact on its day to day operations, the firm did welcome the ruling as indicative of a change in attitude to this type of research.

As McGuigan explained “our government’s willingness to pro-actively support stem cell research has had a very positive overall impact on the world’s attitude about the potential use of stem cells in treatment.

There is much less of a ‘stigma’ about stem cells and their use when you talk about to people about what we do. Overall, we see our government’s willingness to support stem cell research as good for the future growth of the entire industry; therefore, it can have a positive impact on companies like ours​.”

Regulatory support a key market driver

McGuigan also offered his opinions on what factors will impact the development of the stem cell manufacturing industry, both contract and in-house, over the next few years

He suggested that Governments worldwide are likely continue increasing funding for pre-clinical stem cell research and that success in this type of work will inevitably lead to more clinical work.

The second key driver McGuigan highlighted was growing regulatory support for Phase I and II trials, adding that: “We’re seeing more and more approvals for early phase clinical trials each and every day.

Everywhere you travel in the world, the medical community is talking about what role stem cells can play in treating patients, this will translate in a significant uptick in clinical trials​.”

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