The Overlooked Role of Cannabis Drug Manufacturing

Over the last six months, Vitality Biopharma has made a number of breakthroughs enabling us to develop a proprietary new class of cannabinoid pharmaceuticals, file for international patent protection covering these compounds, obtain DEA approval for our research facilities, and most recently to announce our production of novel varieties of THC that have eliminated psychoactivity.

The Company has made significant progress, and the number of initiatives our small team has underway currently leads me to believe the next six months will be even more productive.  Last week, we obtained the latest signal of support from investors with a new financing of $1.5 million through a common stock purchase.  This new cash infusion also puts us clearly on track to achieve clinical development milestones we’ve set forth for 2017.

But one aspect of our operations I’d like to highlight is our capabilities in drug manufacturing itself.  We are a very uncommon drug development company due to our roots in the stevia industry, where we have been refining and optimizing a biosynthetic production process for a sweetener ingredient over the last several years.  This work included designing industrial-scale production processes that were safe enough to meet the FDA’s GRAS requirements.  We built our own facilities to implement GMP production processes.    Because of this, unlike many other drug development companies, we already have a high degree of internal control and confidence in our production methods, which ensures we can move quickly as well as control costs.

Though much of the manufacturing processes we’re using now were developed over the past several years, we continue to optimize them.  As one example, our team was able to recently reduce by more than half the time it takes to produce enzyme biocatalysts for our glycosylation platform.   These are the enzymes that we discovered are able to modify cannabinoids and that are critical for the production of cannabosides.  We will continue to optimize this process as we scale-up production for clinical trials, and especially as we move into Phase 2 and beyond.

Drug manufacturing in biotech is like being an offensive linemen in football; it’s a critical role but they usually only get recognized when the quarterback is sacked.   There are manufacturing scenarios like this in biotech more often than people realize, especially in early-stage companies.  It’s unfortunate because no one wants the lofty goals of a biotech to be shattered by mundane issues related to manufacturing or logistics.

Thankfully, with our recent DEA approval to enable manufacturing scale-up in California, the process optimization work we’ve been conducting since 2013, and our recent breakthroughs in efficiency, it’s clear we are unusually strong in this department.  I expect it will continue to be a strength that keeps driving us ahead in 2017, and that our expertise in drug manufacturing will play no small role in helping us deliver on our mission.

Please don’t hesitate to contact us to find out more, or connect with us on social media through Twitter, Facebook, or LinkedIn.

Best regards,

Robert Brooke, CEO

 

Notice Regarding Forward-Looking Statements

This document contains “forward-looking statements” as that term is defined in Section 27(a) of the United States Securities Act of 1933, as amended and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this document which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the online publication date of this document, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this document are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

 


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