Category Archives: amino acids

Amino Acids Analysis for the Pharmaceutical Industry

Thermo Scientific Dionex article sampleIf 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.

Click here to download their entire PDF

New Application Notes

ANALYSIS ANALYSIS OF MYCOTOXINS IN CANNABIS PLANTS AND CANNABIS-CONTAINING PRODUCTS OF MYCOTOXINS IN CANNABIS PLANTS AND CANNABIS-CONTAINING PRODUCTS

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 IN DIETARY INGREDIENTS AND SUPPLEMENTS

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)

Sodium Amino Acid Standard with Norleucine

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)

Compound
   
L-Alanine 
Ammonia    
L-Arginine
L-Aspartic acid 
Cysteic acid
L-Glutamic acid  
Glycine
L-Histidine  
L-Isoleucine 
L-Leucine  
L-Lysine
L-Methionine-D,L-sulfone 
L-Phenylalanine
L-Proline
L-Serine
L-Threonine  
L-Valine               
Taurine   
L-Cystine    
L-Methionine  
L-Tyrosine 
Tryptophan
Norleucine
Concentrations µM/mL
 
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25
0.25

 

Please contact Pickering Support with any questions.

David Mazawa
david.mazawa@pickeringlabs.com
Technical Support Chemist

Biopharmaceuticals and Amino Acids Analysis

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://www.pickeringlabs.com/wp-content/uploads/2015/03/MA371_010415_Web.pdf

https://www.pickeringlabs.com/wp-content/uploads/2015/03/MA373_010415_Web.pdf

 

Chromatography Quiz #29

Chromatography Quiz #28: 35th Anniversary Word Puzzle – Results

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:

Chromatography Quiz #29 – Amino Acids Elevated Baseline:

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?

   

   

   

2013 Pickering Laboratories North American Catalog

Our latest Catalog for North America is now available!

Click on the link to download the latest product Catalog from Pickering Laboratories, Inc.

Pickering Catalog: http://pickeringlabs-retentiontimes.com/wp-content/uploads/2013/08/2013_PickeringLabs_Catalog_NorthAmerica_LowRes.pdf

Inside our catalog you will find a complete product listing for all instruments and consumables we currently have available. From Sample Cleanup to Post-Column Derivatization, to artificial Perspiration and Saliva, we hope you find something you will find useful!