In general, how has microbiological quality control testing in pharmaceutical manufacturing evolved over the last 20 years and how has this evolution affected the industry as a whole?
Over the past 20 years, the pharmaceutical industry has undoubtedly seen an influx of mergers and acquisitions, coupled with rapid growth. At the same time, we’ve seen a decline in the number of qualified and experienced microbiologists in the talent pool for staffing pharmaceutical microbiology laboratories.
Perhaps linked to that, microbiologically-related recalls for both sterile and non-sterile pharmaceuticals have increased. This is particularly evident in the growing number of FDA citations regarding the absence of objectionable organisms and environmental isolates in laboratory Quality Control programs.
I think the combination of these factors has driven the demand for more rapid and simplified microbiological methods and quality control materials that are needed to meet regulatory requirements and ensure test accuracy.
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Over this same time period what has been Microbiologics’ mission? How has the company helped the pharmaceuticals industry bring safe and effective pharmaceuticals to market over the last 20 years?
Our mission is to provide the highest quality biomaterials for a safer, healthier world. The microbial controls we provide help laboratories ensure their methods, materials, equipment and personnel are consistently producing reliable results and can detect contaminants.
Laboratories adhering to regulations and standards such as CFR 21, USP, cGMP or ISO rely on Microbiologics biological controls for validation, verification and routine quality control of their microbiological methods and ultimately ensure their products are safe and effective for consumers.
Specifically, what biomaterials does Microbiologics currently offer to assist pharmaceutical laboratories to help them meet quality control regulations?
One example is our EZ-Accu Shot for Growth Promotion Testing, a method described in the USP for determining the suitability and acceptance of culture media used in the lab. EZ-Accu Shot is a quantitative microorganism preparation in the form of a lyophilized pellet. It’s manufactured to deliver a concentration of 10-100 CFU, as required by the USP.
The user simply rehydrates the pellet with diluent provided in the kit, vortexes the suspension to mix, then pipettes 0.1ml of the inoculum to the media they are testing and incubates accordingly. It’s one of our most popular products because it’s simple to use, reliable and saves labs the time and frustration of preparing serial dilutions at the required 10-100 CFU concentration.
For tracking and trending environmental microbial isolates, we offer a comprehensive Custom Solutions program where labs can have their environmental strains identified, characterized, preserved and manufactured into a test-ready control format for on-going QC and monitoring. To meet CFR21 and USP requirements, many laboratories include objectionable environmental isolates in their Growth Promotion, Antimicrobial Effectiveness, Suitability and Disinfectant Qualification testing procedures.
Our Custom Solutions program provides labs with a convenient, reliable control format that enables them to seamlessly incorporate environmental isolates into their routine QC procedures.
Looking ahead, are there any quality control testing technologies/services being developed now that will help pharma companies bring innovative products to the market? How is Microbiologics meeting this challenge for its current and future clients?
Currently, we’re focusing our pharmaceutical research and development investments on the emerging microbiome market. The processes, technologies and experience we have in developing advanced microbial controls for more than 45 years lends itself nicely to supporting the control needs of the microbiome research community.
Services and solutions we offer for microbiome research include:
- Isolate and sample analysis using the latest DNA sequencebased technology
- Live biotherapeutic material sourcing, storage and inventory management
- Expert biomaterial preservation, quantitated to desired concentrations
- Custom-designed biotherapeutic materials to provide study consistency