September 13, 2013
Establishing a Good Manufacturing Practices Facility
Serves as a Catalyst for Nuvilex
One of the key catalysts in the near term for Nuvilex Inc. (OTCQB – NVLX - $0.146 – Spec Buy) is the establishment of a GMP (Good Manufacturing Practices) facility. The facility will be used to encapsulate the live cells that are part of the Company’s pancreatic cancer treatment necessary for future clinical trials. While on the surface it may appear that the GMP term is esoteric, the success of many firms in the health care sector depends upon it.
GMP involves a series of complex and specific documentation of production and testing procedures to ensure the production of quality products. Before a facility can be blessed with the GMP moniker, it is overseen and regulated by government agencies, such as the FDA in the United States. Many other industries like the automotive and electronics sector have similar standards including ISO (International Standards Organization). However, the key point is that a drug or device company may develop and pass all phases of the clinical trials for a new drug or technology but may not be able to produce it if conditions violate GMP; this is different from ISO in that the latter is a quality differentiator but not a requirement for production.
The oversight agencies do not necessarily provide a prescriptive list, but a general list of basic principles a company must adhere to in order to comply with GMP. Here is a short summary:
- Controlled and defined manufacturing processes that are validated to ensure consistency.
- Controlled change processes that are validated and documented.
- Clearly written instructions and procedures at manufacturing stations
- Fully-trained operators
- Records of the manufacturing process taken during production and any deviations documented.
- Documentation and history of an entire batch of products
- A system in place for recalling any batch of drugs from sale or the supply chain
- Documented steps and procedures for analysis of complaints about products on the market and recorded measures taken to prevent recurrence.
Clearly, developing the manufacturing and testing processes and procedures to meet GMP is one of the critical next steps for the Company as the final clinical trial stages for its advanced pancreatic cancer treatment commence.
In establishing the GMP facility and standards for the production of the encapsulated cancer-drug-activating cells required for Nuvilex’s future clinical trials in patients with advanced, inoperable pancreatic cancer, the in-house expertise within the Company may be coupled with that of experts from SG Austria, the company from whom the pancreatic cancer treatment was acquired. The latter are those who developed the treatment and who have already produced the encapsulated cancer-drug-activating live cells that are part of the overall treatment according to GMP standards. By virtue of this unique relationship between Nuvilex and SG Austria, GMP production of the encapsulated cells that are part of Nuvilex’s pancreatic cancer treatment should be significantly facilitated and expedited and the Company should avoid the pitfalls often experienced by early-stage biotech firms in producing their products according to GMP standards.
Completing the GMP facility construction and establishing GMP standards for production of the encapsulated cells that are part of its pancreatic cancer treatment serves as a catalyst for the Company and brings Nuvilex one step closer to advanced clinical trials.
For more information, refer to our previous NVLX Reports, Updates and Hot Topics by visiting www.GoldmanResearch.com
Senior Analyst: Robert Goldman
Rob Goldman has over 20 years of investment and company research experience as a senior research analyst and as a portfolio and mutual fund manager. During his tenure as a sell side analyst, Rob was a senior member of Piper Jaffray's Technology and Communications teams. Prior to joining Piper, Rob led Josephthal & Co.'s Washington-based Emerging Growth Research Group. In addition to his sell-side experience Rob served as Chief Investment Officer of a boutique investment management firm and Blue and White Investment Management, where he managed Small Cap Growth portfolios and The Blue and White Fund.
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