Joining Alcami in 2015, Stacey Ramsey, a senior scientist specialized in microbiology, is a scientific expert on microbial retention. Ramsey’s work focuses on the clinical stages of a drug product which compliments her experience in process development and method development in microbiology. Being part of the development process goes beyond running tests on lab samples, which allows Ramsey to showcase her passion while being a fundamental member of the Alcami development process team.
How would you explain filter validation to someone outside of the pharmaceutical world?
From a big picture perspective, filter validation is filtering out microorganisms from a lab sample. In other words, it’s when you have a drug product that it is sterilized by means of a filter. In order to be able to filter out microorganisms, the filter has to have such small pores that it excludes bacteria and, therefore, you’re filtering out bacteria.What are common questions that clients have about your area of expertise and answers to those questions?
People are often surprised that microorganisms are different sizes. Brevundamonas dimuta is the most commonly used one at Alcami because it is one of the smaller organisms out there. It’s also well-characterized, well-known and well-standardized. The focus in the microbiology department is on microbial retention (MR). Most filters are .02 µm pore size. A sterilizing filter is capable of retaining b. dimunata.
What are the key risks involved in filter validations?
MR is well-defined and rarely erroneous. The risk is that it’s difficult and complex to execute. Contract labs are often utilized for these tests because of the great deal of time and expense for companies to perform the tests in-house. At Alcami, we have the experience, lab capabilities and expert scientists to perform these tests.
Why is filter validation important to drug development?
Filter validation plays an essential role in the drug development process. It’s required by the regulatory bodies in support of product submissions that require a sterilizing filter. My expertise is in the aseptic process – anything that is aseptically manufactured and goes through a sterilizing filter needs to be validated through my department.
Where I see the field progressing isn’t so much in the testing itself but the changes in the industry as far as what kinds of drug products come through the pipeline. The drug products are becoming more complex. The tendency to have filter fouling, which means that the flow through the filter slows it itself and stops, makes the process more difficult and increases with the complexity of the drug products themselves.
What is new/exciting/innovative in your field?
Efficient turnaround times for filter validations are really exciting at the Alcami labs. Alcami focuses on timelines and how to get the client’s drug product from development to the market in the best time scenario possible. Industry standards can range upwards to four to six months. Customized turnaround times at Alcami are generally eight weeks; yet our pricing is competitive with those of longer turnaround times. Additionally, we have an advantage in that we are supporting filter validations for our internal drug products. Having our own labs that are associated with our manufacturing sites creates more collaboration and fewer errors.
Are there any of Alcami’s capabilities within filter validations that stands out?
Alcami has the newest version of Flowstar from Pall Corporation, the Pall Flowstar IV, that performs integrity testing of filters. Our equipment has electronic printing abilities that integrate with our electronic laboratory notebook. This makes data review easier for regulatory bodies and for clients to perform and adds an extra assurance of data integrity.
Thank you for interest in microbial retention. Click here to learn more about microbiological testing.
An industry expert in the field of microbiology, especially in the division of sterile drug products, Stacey Ramsey, MS SM (NRCM) has over a decade of front-line laboratory experience in developing and validating microbiological test methodology, and in implementing new processes in the laboratory. Stacey constantly strives for innovation and process improvements, leading to an interest in providing the best possible quality deliverable to clients.