Services

 

Custom Manufacturing 

Separation and Purification of Antimicrobial Congeners

The composition of most USP and EP pharmaceutical products is generally not limited to a single compound, but rather, a mixture containing one or two major compounds and other congeners (related compounds and impurities). TOKU-E Company has several years of experience purifying antimicrobial congeners and has made many of these compounds available through our EvoPure product line. TOKU-E Company employs proprietary chemical separation methods to produce single antimicrobial congeners which can potentially achieve purity up to 99.0%. If your project requires compounds not currently in the EvoPure product line, please contact us

Re-Purification and Removal of Toxic Impurities

As mentioned above, USP and EP pharmaceutical products generally consist of more than one primary compound and contain multiple impurities. In some cases, certain impurities have proven to be an obstacle in some scientific applications. For example, in plant biology, the antimicrobial cefotaxime is routinely used (due to its low toxicity to plants) to eliminate Agrobacterium tumefaciens once its presence is no longer needed after transformation. In this case, a high enough concentration of cefotaxime is required for antimicrobial activity; however, increasing the concentration also increases the impurity content which can be toxic to plant growth. Through extensive R&D, TOKU-E Company discovered a key impurity that was found to be especially toxic to plant growth. This finding prompted the development of cefotaxime, UltraPure – a form of cefotaxime free of the highly toxic impurity and with more stringent impurity limits than USP specifications.  TOKU-E Company welcomes opportunities to pinpoint problematic impurities and subsequently manufacture a product of superior quality with custom purity or impurity specifications for any in vitro application. Contact us for more information. 

Custom Specifications

Certain applications may require antimicrobials to meet precise limits on tested values such as endotoxin content, purity, melting point, and more. TOKU-E Company frequently works with customers to produce products with custom specifications suitable for use in nearly any in vitro application including diagnostics and upstream pharmaceutical manufacturing (ancillary materials). Contact us for more information.

 

Testing Services

 

ED50 Cell Line Testing

ED50 or median effective dose refers to a dose or concentration of some compound that produces a specific effect on 50% of the tested population. TOKU-E Company performs ED50 testing against resistant and sensitive cell lines for each lot of G418 disulfate to demonstrate selective potency and efficiency of G418 disulfate resistant cells in gene selection applications. In addition to internal ED50 testing, TOKU-E Company also offers ED50 testing for any antimicrobial against any cell lines. Contact us for more information.

Minimum Inhibitory Concentration (MIC) and Susceptibility Testing

MIC – MIC or Minimum Inhibitory Concentration is defined as to the lowest concentration of an antimicrobial compound that inhibits visible growth of an organism. Several online resources contain published MIC values of widely used antimicrobial compounds against a wide variety of bacterial species; however, there are several unknown MIC values for certain antimicrobial compounds and microorganisms. TOKU-E Company offers an in-house MIC testing service for any antimicrobial compound and any BSL-1 and/or BSL-2 organism. Contact us for more information.

Custom Testing

TOKU-E Company is able to perform various tests beyond the specifications listed on each certificate of analysis including endotoxin content, USP and EP potency tests, and more. TOKU-E Company is also able to perform spectral analysis such as FTIR, NMR, and MS to fully characterize antimicrobials for use as analytical reference standards, ancillary materials for upstream pharmaceutical manufacturing, and other applications. Contact us for more information.

 

Strain Improvement and Pathway Optimization

Many antimicrobials are made from an industrial process called fermentation where specific strains of bacteria or fungi are grown in very large fermentation vessels containing a liquid growth medium and generally produce antimicrobials as secondary metabolites. Wild type (natural, not modified) organisms are usually not ideal for industrial production of antimicrobials due to highly controlled metabolic pathways and ultimately, low antimicrobial yields. For industrial fermentation, wild type organisms can be genetically mutated or modified in other ways to produce very high yields of antimicrobials or other desirable metabolic by-products. By using proprietary methods and techniques, the TOKU-E CRO closely studies metabolic pathways of antimicrobial producing organisms to develop abnormally high antimicrobial yielding strains of bacteria for use in industrial antimicrobial manufacturing. In addition to developing high yielding strains, the TOKU-E CRO also specializes in altering metabolic pathways of bacteria to encourage synthesis of specific antimicrobial congeners over other antimicrobial metabolites. Contact us for more information.

 

Packaging & Labeling

TOKU-E Company helps facilitate all your production and distribution needs. This starts right from mixing your antimicrobials into solution on-site in one of our production facilities so you don't have to worry about it. TOKU-E offers lyophilized, precisely measured, microgram to milligram size packaging for all antimicrobial powders. These packages help maintain product quality in settings where stock materials are accessed frequently.

Once packaged, TOKU-E will place your specialized label on the product however you like. Labels are crafted with extremely temperature tolerant ink to ensure they stay intact under the most strenuous conditions. There are many boxing options for shipping if you don't have your own custom delivery system. With a purchase order, products can be delivered straight to your customer if you so require.

The TOKU-E warehouses can also hold blanket orders for your company to keep your own inventory down while continuing to supply you as needed. If there are particular products that your company needs on an infrequent basis that you'd like to have available on short lead times, they can be stocked in the warehouse closest to you to cut shipping time down. By hiring TOKU-E as your distribution partner, you can save time and money.