1. FDA Software Solution born in Puerto Rico 



2. 2015 19th Americas Food and Bevarage Show and Conference

Miami, Florida November 1, 2015 - San Juan based Pharmaceutical Systems International "PSI"attended the Americas Food and Bevarage Convention and presented a seminar on FDA Compliance in the Food Industry. Also we are expanding to the Florida region signing partnership and distribution contract of the product PSI/Pharmaway 1.0 with Optimus a leading provider of Enterprise Business Solutions, Mobility, Business Transformation Consulting Services. 


3. PSI-Pharmaway 1.0™ 2015 Client Use Case


Tres Monjitas (Puerto Rico Milkmaid Industry) is a food and beverage manufacturing facility. Tracking the laboratory testing and inventory components of the process is critical to identifying the root cause and for rapid resolution of many items. This is the rationale for the implementation in Tres Monjitas of PSI-Pharmaway 1.0 laboratory and inventory modules and it remains the driving force behind the selection of what laboratory and quality testing information is being tracked in the facility. The selection of PSI-Pharmaway 1.0 laboratory and inventory modules to implement was driven by many factors but with the laboratory testing volume of the Facility steadily increasing along with the work load make the need for a laboratory and inventory tracking system was obvious.


The first step in implementing the system was to determine responsibility for the hardware and software. To remove the hardware and software support burden from Tres Monjitas, the system is hosted by PSI on servers in two separate high-security facilities accessible via the Internet. This ensured that access would not be interrupted by local events. The most sensitive data stayed behind the firewall at the faciltiy for security reasons. To date there have been no access or response time problems associated with this arrangement. There is always the option to move the system to an on-site server if it is ever deemed desirable.

The system has been in use at Tres Monjitas since 4/2015 and almost all modifications to the system have been handled by the PSI staff. The staff at PSI has been available when new or complex situations have arisen that are beyond the scope of the staff. Changes are implemented rapidly and without added programming costs because it is done in-house by people who actually use the system as part of their work. The lab supervisor and the PSI-Pharmaway 1.0 laboratory and inventory developers meet regularly to discuss tracking requirements, etc. The client programming and configuration changes are made, tested, and are ready well before they are needed.  

The normal processes of modifying software are eliminated. For anyone who has experienced this time-consuming and frustrating process comprising endless meetings (1) to define the scope of work, (2) to draw up contracts, (3) to explain to programmers what is needed, and (4) to review what was done and to repeat steps 3 and 4 endlessly, the benefits of this system are obvious. When a change is required, it is discussed briefly by people involved in and knowledgeable about the work, it is executed promptly, reviewed and implemented in hours or days not weeks or months and it is right the first time. This improves efficiency, reduces frustration, reduces implementation time, and reduces cost. The system keeps pace with the ever-changing process in the laboratory. The information gathered helps to prevent errors during a screen, or failing that, aids in quickly identify the source of the problem for rapid resolution. The Validation Package it keep at the PSI faciltity. 



4. PSI Brings Pharmaway 1.0 Novel Solutions for biopharma, food & others manufacturing sectors - Interphex Conf 2014


*Life Sciences Qualification Guideline for the Microsoft Cloud Services - Thu. October 16 2014| 6:00 PM - 7:00 PM | Room 202A

 Novel Solutions for biopharma and manufacturing



5. What is Biotechnology and Life Sciences?


We love technology in general: computing technology, telecommunications, nanotechnology and all developments aimed to augment the human productivity and quality of life. However, the founding members of PSI have a combined experience of almost 35 years in the biopharmaceutical industry and thus, we reserve a special place to it in our hearts.


The medicnines of today versus medicines of the future

Most medicines in the market are based on simple chemical compounds found in nature, or made in a laboratory out of simple compounds. They are generally known as small molecules. The exception to these are antibiotics, which are produced by a living organism (like penicillin and erythromycin) or synthetized from substances produced by a living organism (clarithromycin is made by performing some changes to the erythromycin molecule). While somewhat bigger, antibiotics are still considered to be in the group of small molecules.
Biotechnology is generally about producing extremely big and complex protein moleules which are only produced by living organisms. This size and complexity makes this molecule very delicate and difficult to process. Sometimes a biotechnology product which is succesfully made in a laboratory, is very challenging to produce in large scale.

The benefits of biotechnology therapy

In the past, the insulin aministered to diabetics was produced by animals. Given its source, the human body did not react to it very well. Thanks to biotechnology it has been possible to have bacteria generate human insulin out of human DNA. This human insulin is perfectly compatible with humans and thus, generally well accepted and effective.

Harnessing the abilities of the bacteria

Bacteria has two types of DNA. The regular one is in the nucleous. However the one that give it superpowers is outside the nucleous and is called Plasmid DNA. This DNA is very simple, in the shape of a ring, and can be transferred from one bacteria to other bacterias (even different type) by simple contact. This DNA stores the genetic code that gives the bacteria its adaptive abilities like antibiotic-resistance.
What the scientifics do is that they split this ring and insert in the middle a chunk of human DNA. Then they insert the ring back in the bacteria, and place the bacteria in liquid full of food for the bacteria to reproduce into a colony. Each of these bacteria will produce, among other things, the protein that the inserted human DNA was programmed to produce. However, the desired protein is still inside the celular wall of the bacteria.The tricky part is opening the bacteria to extract its content, and then separating the desired protein from all the other substances inside the bacteria, without damaging it.
Notice that all this process must be performed in a perfectly sterile environment, as it is not possible to use heat or chemicals to kill viruses or other germs without damaging the desired protein. So, after the bacteria is opened, the desired protein is separated using different filter types (some of them are similar to the filters used to process beer). The rest of the process is to formulate the drug to correct concentration and package it. The final product is stored at very low temperatures to protect it from damage. 

What else in the industry?

Well, the process explained above is the core of the concept. However, this fall shorts of understanding the whole process for creating a new biotechnology drug. R&D departments in biotechnology companies dedicate millions of dollars to investigate and explore potential candidates for new drugs. This process is lead by biotechnology scientifics but is also supported by Information Technology analysts dedicated to bioinformatics. These bioinformatics professionals apply Data Mining techniques to the DNA sequences being analyzed to try to find patterns on the genoma associated to specific human conditions.
There is also huge crews of scientifics and supporting personnel dedicated to support phase one, two and three clinical trials. And, there are also other teams with scientifics and engineers dedicated to transform the laboratory process into a industial level factory that will produce exactly the same product developed in the laboratory.



6. Guayacan Group select PSI-Pharmaway 1.0™ as a semifianalist of the 2014 Enterprize Competetion!

San Juan, PR, -- San Juan based Pharmaceutical Systems International announced today that the Guayacan group selected Pharmaway 1.0 as a semifinalist of the EnterPrize competetion. 

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