Drug Discovery & Pharmaceuticals
Quality Control for the Pharmaceutical Industry
Quality control of pharmaceutical products is an important matter for industrials and testing laboratories. The evaluation of the analytical performance of laboratories is essential to ensure the accuracy of the analytical results. Laboratories’ participation in proficiency tests allows these performances to being evaluated.
Created in 1970, BIPEA is a scientific and independent non-profit organisation providing Proficiency Testing programs and Reference Materials in the fields of food, feed, environment, cosmetic, pharmaceutical and hygiene. BIPEA is ISO 17043 accredited (scope 1-1495 available in
www.cofrac.fr), ISO 90001 certified and gathers more than 2500 testing laboratories, in 120 countries.
In the field of pharmaceuticals, BIPEA offers 3 proficiency tests: PT 104 ‘Microbiology of pharmaceutical process water’: enumeration of total viable aerobic germs; PT 97 ‘Purified water for pharmaceutical applications’: Endotoxins & TOC are offered for analysis on a purified water sample; PT 98 ‘Residual solvents in excipients’: Ethylene oxide and Dioxane on a Polyethylene glycol sample are offered for analysis.
These three programs are designed according to the pharmacopeia requirements (European, American, Japanese pharmacopoeia, or any other pharmacopoeia).
More information online:
ilmt.co/PL/KBkJ and
ilmt.co/PL/nZQ0 57446pr@reply-direct.com
New Video Showcases Pipetting Productivity in a Real-life Situation
Integra Biosciences has created a testimonial video showcasing their VOYAGER adjustable tip spacing pipettes many useful features. The video shows how the pipette increases productivity using a real-life situation, portraying how researchers at the National Centre for Scientific Research (CNRS) in Montpellier, France, are using it to study the dynamics of the latent HIV reservoir and investigate drug-resistant mutations.
Latent HIV reservoirs are one of the main reasons that the disease is so far uncurable, making it impossible for the antiretroviral therapies to completely eradicate the virus. The team therefore works to gain a deeper understanding of the mechanics of the reservoir to improve the effectiveness of HIV treatments. The CNRS team’s workflow requires up to 20 PCR plates to be prepared for each patient sample, as well as loading hundreds of samples into electrophoresis gels for size analysis. They therefore decided to start using the VOYAGER to speed up these processes, and it has been a game-changer for large-scale screening activities. The automated adjustment of tip spacing allows multiple samples to be transferred between different plate formats, from tubes to plates, or from plates to gels in parallel, cutting several hours of work down to just 10-15 minutes!
Visit the Integra Biosciences website to watch the video. More information online:
ilmt.co/PL/XOV0
57498pr@reply-direct.com
Single-use Pharma Separator for Superior Cell Culture Processing
Research institutes and companies in the pharmaceutical industry from Europe, Asia and Europe have welcomed the kytero® Single-Use Pharma Separator from GEA following its launch in 2021. The system offers high separation efficiency, simple and gentle product handling and the elimination of costly cleaning procedures.
kytero® creates new ways for processing cell culture-based fermentations with a yield of 98% and more. This type of technology is in high demand for pilot plants, university laboratories, and small-scale production by biopharmaceutical manufacturers worldwide, as it relies on the well-established technology of disk separators. The use of filtration technology can thus be significantly reduced. The kytero® 500 was developed for a capacity of up to 150 l/h and is thus suitable for laboratories and small batches. For reliable scale-up, another model will follow in due course.
In centrifugation, unlike filtration, the separation of the medium is not achieved by filter media (filter plates and filter cloths), but by utilising the centrifugal force that occurs in conjunction with a disc stack for increased clarification efficiency. The mobile ‘Plug & Produce’ unit with a minimal footprint fits easily into any production room.
With the single-use separator, all product-contacting parts are replaced after use, preventing any cross-contamination without the need for cleaning and sterilisation. The frictionless drive system provides 100% biocontainment by eliminating the need for seals or mechanical bearings. Set-up and changeover time is minimal. No auxiliary equipment such as water, buffers, or tanks is required.
The noise level is very low at less than 69 dBA due to the newly developed breezeDrive® drive system. The temperature increase of the product, which is unavoidable during centrifugation, is minimal at less than two degrees. GEA kytero® inspires the pharmaceutical industry with its high separation efficiency, gentle product handling, easy and safe handling, and minimal set-up times. GEA provides test machines.
More information online:
ilmt.co/PL/zRvy 57229pr@reply-direct.com
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