Microbiological Evaluation & Testing

Non-pharmacopeial molecule evaluation:

Research Programs undertaken in Biotechnology and Pharmaceutical companies include looking out for innovative products or modifying the existing ones for better properties and spectrum. Such New Chemical Entities (NCEs) or products require extensive study before they could considered as promising molecules or products.

Neither any pharmacopeial methodology nor any standard testing method is normally available for such type of innovative products.

Many of these molecules or products have to prove their efficacy microbiologically in addition to physico-chemical test. In fact, most of the time, the crucial and deciding evaluations are microbiological.

We have the required expertise to design and conduct these difficult evaluations and provide experimental evidence on their performance. Some of the studies that we have conducted are on lactic acid bacteria, anti-fungal compounds, anti-bacterial compounds, screening for spectrum of bactericidal agents, microbiological response for special rDNA protein, designing biological assays, etc.

Microbiological Investigations:

Having expertise in the sterile dosage requirements of pharmaceutical and biotechnology facilities and understanding the low bioburden requirement in Nutraceutical production facilities, we offer consultancy services on the following aspects:

To find out reasons for Media Fill Failures. To find out reasons for Product Failures. Handle and investigate market complaint of microbiological nature. Finding contamination source and suggest corrective measures. To address failure to comply with Environmental Monitoring program. Identifying the type of contamination and tackling the same.

Identification of Microorganisms:

One of the serious concerns of the pharmaceutical, biotechnology and nutraceutical industry is correct identification of the microorganism of interest. Be it a dangerous organism or repetitive contaminant or a precious isolate that you are interested in - correct identification up to species or even subspecies level is a must.

We undertake such identification of microorganisms by varying degree of necessity as per your requirements. From basic biochemical tests to using specialized kits and finally up to genetic analysis. A report is submitted at the end of the testing.



Pharmaceutical Microbiological Testing:

We provide guidance on and also undertake the following:

Biotechnological Testing:

In the revolutionary field of biotechnology, there are always situations where, in addition to the in-house expertise, one needs to counter check the quality or evaluate the process steps designed for purification. It is here that we fill the gap for you. On one hand we have the prerequisite understanding about the subject and on the other hand we have the necessary tie-ups with reputed institutes where they have the infrastructure to carry out the work. With this combination, we undertake your external testing work and technically liaise with you as well as the institute to give you the much needed back-up.

To name some of the tests that we undertake: