This blog can tell you all about measuring sterility during the drug development process!
While inactivated or live attenuated vaccines usually dominate the market, a newer generation of viral vaccines known as recombinant viral vectors, or VLPs (virus-like-particles, are in the pre-clinical and clinical development phases. Viral vectors are widely used for gene therapy and oncolytic applications. Read on to learn more about measuring sterility during the drug development process!
Mycoplasma Detection
It is possible to detect mycoplasma within three hours. Microstart Mycoplasma AMP qPCR kits are a rapid, reliable, and simple-to-use solution in compliance with some international guidelines. Samples can be easily taken from cell cultures or sterility canisters for testing.
The proof of sterility is usually complete downstream to ensure a viable product free from contaminants. Batch release sterility testing with the Sterisart NF canisters and the Universal pump is used in Sterility testing that adheres with the international pharmacopeia requirements. The unique features of the Sterisart Canister allow for sample testing without compromising the canister sample.
Microbial Air Monitoring
The portable unit can be used in any room and can measure both bacterial and viral loads. The air monitoring unit is used for the quantitative detection of airborne microorganisms. The MD8 unit is combined with pre-filled culture media plates that fit on the unit. The integration culture plate is also a collection head with over 400 holes for maximum sampling efficiency.
Pharma Compliant Weighing for Your Lab
Cubis II Premium Lab Balances and Sartorius Cubis II are designed to follow US FDA data integrity principles that require different data to be accurate, contemporaneous, legible, original, and attributable. The Cubis II balance, with some pharma package, contains all of the technical controls to help support full compliance with other standard regulations.
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