Physical/Organoleptic Measurement (IR, HPLC, UPLC) for Live Biotherapeutic Products

Recent advances in DNA sequencing, gnotobiotics, metabolomics, RNA sequencing, and culturomics have markedly propelled the research of live biotherapeutic products (LBPs), also referred to as next-generation probiotics (NGPs). With extensive expertise in the human probiotic field, Creative Biolabs has explored a delicate live biotherapeutics discovery platform for LBPs isolation, identification, analysis, and cGMP manufacturing. Physical or organoleptic characterization of LBPs is important to delivering quality drug products.

LBPs and Related Physical Tests

LBPs exert beneficial effects on the host’s health when ingested in sufficient viable numbers. They have the potential to 1) balance the gastro-intestinal (GI) tract microflora, 2) modulate immune responses, 3) improve the utilization of nutrients, 4) decrease the symptoms of lactose intolerance and allergies in susceptible individuals, 5) reduce the risk of cancer, 6) alleviate irritable bowel syndrome and inflammatory bowel diseases. The harsh environment in the upper gastrointestinal tract (such as low pH values and pepsin presence and high bile salt concentrations) determines that we need to select and identify the most appropriate strains that must survive during the transit through the stomach and small intestines. Physical measurements have been applied for the rapid selection of probiotic strains.

Physical Tests at Creative Biolabs

• Infrared Spectroscopy (IR)
  • Introduction

  IR often combined with Aquaphotomics has been applied to monitor the growth of probiotic bacteria. It is time-efficient and allows rapid, chemical-free, non-invasive in vivo assessment, providing an opportunity for researching live microorganisms in the cultivation process.

  • Services

  Creative Biolabs utilizes this method to measure bacterial growth rate, maximal optical density, low pH, and bile tolerances. The huge amount of data can be used as a reference for the research and diagnostics of various species and identification and discrimination of bacterial species at very low concentrations.

  Fig.1 Infrared Spectroscopy (IR).

  • Advantages

  Quick, inexpensive, sensitive, high-accuracy.

• High-performance Liquid Chromatography (HPLC)
  • Introduction

  HPLC is an effective analytical technique for the determination of active components during the cultivation process.

  • Services

  Creative Biolabs utilizes this method to identify and quantify active prebiotic ingredients, which may promote the survival, colonization, and activity of the probiotic strains in the gastrointestinal tract to improve the beneficial effects in health. Now, we can detect various bioactive substances excreted by probiotic bacteria, including but not limited to biogenic amines, lactic acid, butyrate, (+)-catechin, and (−)-epicatechin, etc.

  Fig.2 Determination of probiotic abilities and lactic acid content by HPLC. (Kiymaci, 2019)

  • Advantages

  Simple, precise, rapid, and reliable.

• Ultra-performance Liquid Chromatography (UPLC)
  • Introduction

  UPLC, evolved from HPLC, is a completely new system design with advanced technology. It is also applied to the detection of the sensitive and selective determination of trace amounts of active compounds in the cultivation process of LBPs.

  • Services

  Creative Biolabs utilizes this method to identify and quantify active prebiotic ingredients and potential toxins of therapeutic LBPs. It can help to evaluate the quality and safety of prebiotic drug products. Usually, UPLC is used by combining with tandem mass spectroscopy (UPLC-MS/MS) for fractions analysis.

  • Advantages

  Ultra-efficient, sensitive, fast, and multianalyte method.

Physical measurements are simple and effective analytical methods for measuring the composition, stability, and potency of LBPs. Creative Biolabs has expanded the application of IR, HPLC/UPLC tests to the analyses of prebiotic drug products. If you don't find what you need in the above service items, please feel free to contact us for a tailored solution.

Reference

1. Kiymaci, M. E.; et al. Determination of Probiotic Abilities and Lactic Acid Content of Pediococcus acidilactici. Current Analytical Chemistry. 2019, 15(4): 511-521.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.