Pharmaceutical Microbiology: The 4 Best Calibrated QC Strains

In the pharmaceutical and medical device industries, we are asked to perform so many growth promotion tests (GPT) that often the use of ready-to-use, calibrated strains is more cost-effective… provided that you can find a good QC (Quality Control) strain supplier!

To assist you in this quest, we asked the SuperMicrobiologists (9,700 followers on the LinkedIn page) which calibrated strain suppliers they preferred.

Here are the 4  best quality control strains according to the SuperMicrobiologists.

Content :

• BAControl from ielab
• Vitroids and LENTICULE discs from Merck
• CRM from Biosisto

BAControl from ielab

ielab is a specialized supplier of microbiological reference materials based in Spain. All materials are produced following ISO 17034 requirements. 

Reference Culture Collection: CECT (Spanish Type Culture Collection).

Strain storage: -20土5ºC

Three concentration ranges available:

• <100 cfu/0.1ml (for fertility tests)
  
• 100 cfu/0.1ml
  
• Between 10E5 and 10E6 cfu/0.1ml (for Challenge test)

BAControl Strengths :

• Pharmacopeia: All strains from the European Pharmacopoeia are available.
  
• Large number of tests: Pellet is dissolved in 20 ml at room temperature. A large number of tests is then available 200 x 100ul.
  
• Easy to use: One-step preparation (dissolving the pellet in 20 ml of sterile water). The strain is ready in 10 minutes.

If required, CRM strains available (reference name is BACuanti)

ielab environmental isolate (Reference materials produced from environmental isolates)

ielab offers a customized strain production service. You send them your endogenous strain, and they transform it into a ready-to-use lyophilized strain at the desired concentration. 

Strengths of ielab environmental isolate

• Production time is usually around 1 month.
  
• Ielab offers the possibility to store the isolated strains at (-70 ± 10ºC).
  
• They also offer to identify the microorganism using molecular methods (16S sequencing). 

This process allows you to adopt a single protocol for all your QC (Quality Control) strains.

ielab distributors contacts
ielab contact – Tell them you’ve come from SuperMicrobiologists 😉

The others QC strain suppliers mentionned by the SuperMicrobiologists are : Bioball from bioMerieux, Accushot from Microbiologics and Quanticult from Thermo

The Challengers

Vitroids™ and LENTICULE^® discs from Merck*

Merck offers a full range of ready to use calibrated QC strain for the pharma industry. Cherry on the cake, all of their culture strains are Certified Reference Materials (CRMs).

All materials are produced following ISO 17034 requirements

Reference Culture Collection: NCTC^® (National Collection of Type Cultures) / NCPF^® (National Collection of Pathogenic Fungi) and CECT^® (Colección Española de Cultivos Tipo)

Strain storage: -20土5ºC

Concentration ranges available:

• 15 – 80 cfu (for Growth Performance Tests)
  
• 80 – 130 cfu
  
• 1000 – 10 000 cfu
  
• 50 000 – 150 000 cfu

Vitroids™ and LENTICULE^® discs Strengths :

• Extremely simple to use : No dilution is required (for the GPTs). You just drop the disc on your agar plate, wait 15 minutes, then spread.
  
• Long Shelf Life : At least 16 months.
  
• Exact number : Each batch of these strains has a CoA (Certificate of Analysis)  which includes the average number of microorganisms you have in each discs plus an expected range.
  

*The Life Science business of Merck operates as MilliporeSigma in the U.S. and Canada.

Certified Reference Materials (CRM) from Biosisto

Biosisto provides a comprehensive range of ready-to-use calibrated QC strains for the pharmaceutical industry. Most of their culture strains are Certified Reference Materials (CRMs).

Reference Culture Collection: Biosisto uses NCCB Collection (Netherlands), the CCUG Collection (Swedish), and the CBS Collection for yeast and mold (Netherlands). These strains have been assigned a WDCM (World Data Centre for Microorganisms) number, which ensures that they are equivalent to those specified in pharmacopoeias.

Strain storage: -80°C

Concentration ranges available:

• 3.000 to 15.000 cfu/ml – A Certificate of Analysis accompany each CRM with the exact concentration.

CRM Biosisto Strengths :

• Long Shelflife : Storage at -80°C guarantees a shelf life of at least two years.
  
• Compare your results with other labs : Free access to the online BiosistoChart for recording your results and the option to compare them with other laboratories anonymously.
  
• Easy to use : Defrost it for 30 minutes, and the liquid is ready for use. The CRM can be used throughout the day when stored in the refrigerator.
  

If the CRM you need is not included in the Biosisto collection, they can customize CRMs tailored to your specific strain and concentration requirements

Which QC strains did you choose? Share your experience in comments.