Decide, for GeneDia, to produce application kits of Molecular Biology in Italy beginning, back in 1992, from virtually nothing, it was not an easy choice, indeed, very painful.
Why did we do it?
We were pretty much forced, because, realizing to have ideas and expertise in the field of molecular diagnostics such as to enable us to develop and design innovative approaches and solutions, we have not been able, despite having tried, tried again and invested with a couple of production realities of pharmaceutical products, to obtain the desired results.
The objective difficulties in the production of Molecular Biology kits at that time there have appeared, therefore, obvious enough to make us decide that the only chance of success resided in the in-house production; and we chose this road.
Today, in 2001, we feel confident when we decide to start production of a new kit, but, at that time, and for a few years only we (and some customers in search of innovative solutions) remember how many and what problems we faced, how many sleepless nights, how many unexpected surprises that more and reopening new problems, even after months of successful use of the solution in use at customer sites.
And today, when we draw the specifications of a new product to be launched on the market and we put the item "Stability" the phrase "over 12 months if properly stored" we feel not only peaceful, but also proud.
We are pleased, therefore, to explain briefly, before there inoltriate in knowledge and assessment of our products, the process that underlies the market launch of a new application kit GD.
- Identification of the need in the market
- Acquisition of specific knowledge of the need and found the same framework with respect to the framework, through an appropriate literature search
- Practical, hands on application of the methodology for drawing up a working protocol
- Analysis of the working protocol developed and feasibility study of an application kit (LINK)
- If considered "feasible" we will produce some prototypes that are transmitted to the production that studies and implements engineering, packaging and with them the "practicality" constructive
- The R & D department, based on the positive opinion of Production, begins an appropriate set of user tests on real samples
- After the final which produces technical specifications on the basis of which the production started to produce a lot "experimental".
- This batch is normally used on two fronts: externally at a laboratory which evaluates the characteristics and produces data for the validation and internally for the development of an internal protocol of Quality Control, is essential from the beginning of the production phase for the marketing.
- The production phase and distribution takes place in certified quality system ISO 9002
Feasibility study of an application kit
The development of an application starts from the study of the available literature on the topic chosen by following two different directions: the first addressed to the understanding of the diagnostic implications that may ensue, while the second revolt, the methodology already in use and that potentially can be used to get the result.
The first milestone is represented, therefore, the ability to profitably apply the results of the proposed test. This stage, despite having a huge value because it defines the potential distribution of the kits, is defined largely by the contribution of the scientific context that deals with the subject in question.
As it competes more properly to research and development of a company that designs kits for distribution, it is the study of the most suitable methodology and protocols, so that we can assemble the reagents needed to perform the test.
The guidelines that are followed are easily imaginable; It is in fact hopes to achieve a situation where the reagents in use have, consistent with ensuring the success of the test, the following main characteristics:
1) Long-term stability in the simplest possible storage conditions;
2) Assembled in non-dedicated operating conditions;
3) Number of reagents minimized;
4) Standardization of the results obtained;
5) Simplicity of use of the method;
6) Low cost.
These features are of a general nature, that is to say, apply to any type of analytic investigation you want to develop; next to them the philosophy of the company and the manufacturer of the individual members, are the essential components that give the kit the peculiarities which link it to a particular manufacturer.
We like to bring the philosophy that has guided us so far in the design of all GeneDia systems. It was above all to always respect the nature of the survey that you do, without depriving itself of the cultural bases necessary for the execution of the test itself. We mean that we have tried to simplify and standardize the methodology without hiding the difficulties related to its implementation in end-user laboratory, and emphasizing the advantages and problems related to the execution of the survey.
This is done for the exclusive benefit of the end user, with the study of open protocols and versatile, with the distribution of modular systems and helping even with an effective and real application support, in order to involve all the way in related to 'problems test execution, because he does not remain relegated to the position of mere executor.