If you are interested, feel free to check out some cool work that Thermo Scientific published on behalf of RSSL in the United Kingdom, using an ICS-6000 in combination with a Pickering post-column system to perform Amino Acids Analysis for the Pharmaceutical Industry.
RSSL expands GMP services for the pharmaceutical industry with combined Thermo Scientific Dionex ICS-6000 HPIC System—Pickering Pinnacle PCX amino acid analyzer solution.
No other analytical technique, including pre-column derivatization followed by reversed-phase chromatography, has been shown to match post-column ion-exchange methods in accuracy and reproducibility. This is because the retention mechanism in ion exchange provides for chromatography that is almost completely matrix-insensitive. Simple sample preparation for native samples is an added benefit of the ion-exchange method.
With the alternative pre-column derivatization method, the prepared sample is subject to a chemical reaction that takes place in a very complex medium: the residual matrix. Matrix complexity produces both competition and inhibition in chemical synthesis, resulting in decreased reproducibility in peak areas and retention times. Very often, the pre-column method must be optimized for each different sample matrix. In contrast, ion-exchange chromatography followed by post-column derivatization is intrinsically more rugged and repeatable, since the matrix components do not retain on the cation-exchange column and have no influence on separation or derivatization of amino acids. The same method can be used for variety of samples, from plant extracts to serums or spinal fluids.
Pickering Laboratories, Inc. provides a complete solution to Amino Acid Analysis. We supply columns, eluants, reagents and post-column derivatization instruments that work seamlessly with virtually any modern HPLC, so we can guarantee the accuracy and reproducibility of the analysis. Our chemists will help you choose the method and instrumentation best suited to your requirements, work with you on any custom method optimization and offer continuous support in day-to-day operation.
Download a copy of the brand-new Amino Acids Analysis brochure here. Do not hesitate to contact Pickering Labs Support (support@pickeringlabs.com) with any questions.
David Mazawa
Technical Support Chemist
Pickering Laboratories, Inc.
1280 Space Park Way
Mountain View, CA 94043, USA
david@pickeringlabs.com
Phone: (650) 694-6700 x710
By Maria Ofitserova
As novel Covid-19 virus spreads around the globe, pharmaceutical companies worldwide are racing to develop vaccines, therapeutic agents and prophylactics to combat the disease. A lot of these pharmaceuticals are biologics – in other words, they are either isolated from natural sources or manufactured via biotechnology methods.
The focus on biological products during the current pandemic has highlighted the crucial role Amino Acids Analysis plays in the research and production of pharmaceuticals. As a result, Pickering Laboratories is seeing a surge in demand from customers requiring the consumables necessary to support these critical efforts.
Amino Acids Analysis can be used for:
Our Amino Acids Analysis methods allow laboratories to perform testing according to European Pharmacopeia as well as testing of hydrolyzed and native substances.
Though it seems the focus is now set firmly on pharmaceutical industry, there are other vital areas of amino acids testing that cannot be overlooked. No less important is the Amino Acids Analysis of physiological samples done by hospitals and clinical laboratories. Testing of newborns for inborn errors of metabolism, such as PKU and MSUD, as well as monitoring amino acids markers for different medical conditions, including rejection of organ transplants, metabolic disorders and diabetes, are all tests that still have to be done in a timely manner to prevent adverse health outcomes, pandemic or not.
Preventing disruption in food supply is another area that needs amino acids analysis to continue uninterrupted during the global Coronavirus crisis. Feed and food testing laboratories are already under stress due to special quarantine requirements, so providing a steady supply of reagents and chemicals is another way Pickering doing its part in keeping these industries running.
As an expert in Amino Acids Analysis and a trusted supplier of related consumable products, Pickering Laboratories is focused on supporting our new and existing customers as they navigate increased demand for testing. We are open for business and operating at full production capacity during the pandemic.
During these trying times, we are proud to continue providing timely product delivery and technical assistance to help ensure uninterrupted operations for essential children’s hospital, clinical laboratories, pharmaceutical companies and their testing laboratory partners, not to mention drinking water and food testing labs worldwide with our other post-column applications.
To learn more or ask specific questions about our product availability and up-to-date lead times, please contact us at orders@pickeringlabs.com or support@pickeringlabs.com and we will gladly address your concerns.
State regulations have established maximum allowed levels for Mycotoxins in Cannabis-containing products sold to consumers at the following maximum levels: levels for total Aflatoxins G1, G2, B1 and B2 are set at < 20 ppb and levels for Ochratoxin A at < 20 ppb. Pickering Laboratories developed an easy and sensitive method to analyze Aflatoxins B1, B2, G1, G2 and Ochratoxin A in cannabis plants and edible products. Mycotoxins are isolated using immunoaffinity clean-up columns and analyzed with fluorescence detection. To increase sensitivity of Aflatoxins B1 and G1, an in-line photochemical reactor is installed before the detector. This method utilizes standard HPLC equipment and allows testing laboratories to easily determine Mycotoxins at levels below the limits established by state regulations.
Click to download Analysis of Mycotoxins in Cannabis Plants and Cannabis Containing Products (MA241).
Analysis of amino acids using cation-exchange columns and Ninhydrin post-column reagent is well-establish methodology that is recommended by the European Pharmacopeia. Pickering Laboratories developed and validated a post-column method for amino acids analysis of dietary supplements that is sensitive, selective and can be used without modifications to analyze capsules, tablets, drinks and other samples. Accelerated methods are available for samples with a limited number of amino acids.
Click to download Analysis of Amino Acids in Dietary Ingredients and Supplements (MA397)
Dear valued customer,
A new amino acid standard is available for your convenience. This expanded comprehensive set of amino acids with internal standard, Norleucine, can be used for oxidized or non-oxidized samples.
Please see the components listed below.
1700-0165 Sodium Amino Acid Standard with Norleucine, 0.25µmole/mL, pack (5x1mL)
Please contact Pickering Support with any questions.
David Mazawa
david.mazawa@pickeringlabs.com
Technical Support Chemist
By Maria Ofitserova
Biopharmaceuticals are large molecules produced by or extracted from biological sources. They are used for therapeutic as well as diagnostic purposes and include recombinant proteins, antibodies, vaccines, blood factors, hormones and many other types of substances. Currently, there are more than 200 biologics on the market and they account for almost a third of all pharmaceuticals under development.
These unique substances revolutionized the pharmaceutical industry and brought tremendous improvement to the treatment of many medical conditions. They also brought their own set of challenges in manufacturing, quality control and regulations. Most biopharmaceuticals are developed by using recombinant DNA technology, where specific proteins are produced by genetically engineered cells. As such, biologics are very sensitive to changes in the production process and they are more difficult to characterize than synthetic drugs. Even small changes in manufacturing conditions or cell lines can cause considerable variations in final product, causing differences in therapeutic action. That is why, unlike with synthetic generic drugs, biosimilar compounds require clinical trials to prove the drug equivalency.
All cell lines require media to grow and function. Cell culture media have complex composition that needs to be optimized to ensure proper functioning of the cell lines. The type of media needed would depend on the manufacturing process mode as well as stage of cell line life. For example, media needed for optimum cell growth would be different from the one required for optimized production rate of the final product. Optimum cell media should be able to sustain high cell density and maximized production yield.
Amino acids, being the building blocks of proteins, are necessary ingredients of all cell culture media. Since cells can’t synthesize essential amino acids, they must be included in the media to ensure cell propagation and functioning. L-Glutamine is one of the most important essential amino acids since it serves as a Nitrogen source as well as energy source for cell metabolism. Non-essential amino acids also get depleted during cell line lifetime, so supplementation of such amino acids as L-Proline, L-Serine and L-Alanine is also necessary. Monitoring amino acids at various stages of the manufacturing process ensures viability of the cells and high quality of the final product.
Due to complexity of composition and structure, biopharmaceuticals are challenging to characterize. A wide array of methods, such as immune assays, gel electrophoresis, different chromatographic and mass spectrometric techniques are used in combination to fully confirm the substance purity and identity. The ICH Q6B is a guidance document that provides a set of internationally accepted specifications for biotechnological and biological products to support new marketing applications. (https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073488.pdf) Determining amino acid composition following hydrolysis is listed in Q6B as a way to characterize the protein and to confirm its identity by comparing with the amino acid composition deduced from the gene sequence of the desired product. Amino acids analysis data is also used to accurately determine the protein content.
Pickering Laboratories offers methods to analyze amino acids in hydrolyzed protein samples and well as cell culture media. See our application notes 373 and 371 for more information.
https://atloggerheads.net/wp-content/uploads/2015/03/MA371_010415_Web.pdf
https://atloggerheads.net/wp-content/uploads/2015/03/MA373_010415_Web.pdf
Pickering Labs would like to congratulate all of our winners for our previous newsletter’s 35th Anniversary Word Puzzle: Jim Balk from Nebraska DHHS Public Health Environmental Laboratory, Tom Schneider from Suffolk County Water Authority, Karissa Scroggins from North Coast 
Laboratories, Narjes Ghafoori from LA County Environmental Toxicology Lab, Joy Gottlieb from New Mexico Department of Health Scientific Lab Division, Hossein Hajipour from Texas Dept. of State Health Services Laboratories, and Widchuda Meeim from Thailand Bureau of Quality Control of Livestock Products.
Winners will soon receive a Packing Organizer Set from the Container Store! This colorful set of 6 packing cubes are durable and clearly labeled to help you organize your suitcase! Just in time as you plan for those summer getaways!
Congratulations to our quiz winners and happy packing!
Thank you all for your submissions!
The correct answers for the Anniversary Word Puzzle are as follows:
Simply email your answer as well as your full contact information to Rebecca at rlsmith@pickeringlabs.com by July 15, 2018 in order to win. You will receive email confirmation that your submission has been received. The answer to the quiz and winner congratulations will be published in the next issue (to be anonymous, please notify Rebecca in submission).
Maroon: Good chromatogram
Blue: Elevated baseline
What could be contributing to the elevated baseline?
