Molecular Biology

Physical characterization refers to the process of measuring and analyzing various physical properties of materials. Some common techniques used for physical characterization are:

 

 

Thermal Services

 

X-Ray Diffraction

 

Particle Size Distribution

 

Rheology and Viscosity

 

Texture

 

Specific Surface Area (SSA, BET) and Density

 

Powder Flowability

 

 

 


Thermal Services

 

 

Why choose our Thermal Service offering?

 

DSC and TGA can be applied in a broad range of ways to elucidate the number of polymorphs, hydrated forms, melting point, Tg, degradation behaviour, polymorphic conversion, recrystallisation and heat capacity of an API and excipients. DVS is used to study the response of material to changes in humidity, it is essential in understand physico-chemical behaviours such as stability and microbiological activity. Moisture induced phase changes can affect mechanical properties, induce chemical and biophysical interactions which can lead to changes in dose, yield and efficacy. XRD is a complimentary technique (see XRD offering).

 

 

Capabilities

 

  • Optimum polymorph and salt form determination
  • Degradation behaviour and thermal stability predictions
  • Thermal degradation/decomposition behaviour
  • Crystalline/Amorphous content determination
  • Determination of the heat of fusion/crystallisation to support processing condition development
  • Establishing oxidative induction times
  • Excipient compatibility screening
  • Amorphous solid dispersions stability
  • Investigation of phase separation in blends of polymers/copolymers
  • Estimation of critical temperature of explosion for the energetic industry

 

 

Equipment

 

  • TA TGA 5500
  • DSC2500
  • SDT650 (TGA/DSC combined)
  • DVS Advantage

 

 

 


X-Ray Diffraction

 

 

Why choose our X-ray Diffraction offering?

 

 

The physical form of ingredients used in both food and pharmaceuticals can have a major impact on the desired properties for finished products. X-Ray Powder Diffraction (XRPD) is a powerful technique both on its own and in combination – DSC, TGA etc. XRPD can help to determine which available polymorph is most desired.

 

 

Capabilities

 

  • API solid form determination
  • Stability testing and trending of degradation/crystallinity percentage over time
  • Release testing
  • Characterisation of amorphous solid dispersions
  • API polymorph and salt screening
  • Identification of possible costly food and pharmaceutical processing issues before they arise. For example, tablets breakages and/or food characteristics.
  • Food and Pharmaceutical troubleshooting from formulation to consumer complaint
  • Method development/validation for crystalline content and identification

 

 

Equipment

 

  • Bruker D2 phaser

 

 


Particle Size Distribution

 

 

Why choose our Particle Size Distribution offering?

 

Particle size distribution (PSD) is a fundamental measurement in the product life cycle. The link between particle size and product performance are known to affect dissolution rate, absorption rates and content uniformity. The processability and stability of a formulation are all dependent on PSD.

During formulation of a product the flow and packing properties, tablet and capsule fill volumes, compression, dissolution and blend uniformity can all be affected by PSD. At RSSL we have a series of instruments that allow the measurement of PSD and particle shape/morphology. We are also highly experienced in method development and validation.

 

 

Capabilities

 

  • Method development/transfer/validation/verification
  • Pharmacopeial testing
  • Release testing
  • Stability testing
  • Investigatory / troubleshooting / problem solving analysis
  • Comparative analysis

 

 

Equipment

 

  • Malvern Mastersizer 2000 and Mastersizer 3000
  • Zetasizer ZSP (Zetapotential and DLS)
  • Sieving
  • Lumisizer (emulsion stability) (Analytical centrifuge to monitor accelerated stability of multi-phase samples.)

 

 

 


Rheology and Viscosity

 

 

Why choose our Rheology/Viscosity offering?

 

Our experts in rheology are able to apply their knowledge and analytical skills utilising our wide range of analytical techniques and formulation types. Emulsion or suspension formulations including, ointments, lotions and gels often need specific flow properties to enable them to remain stable, be dispensed appropriately, placed into suitable containers and applied correctly. Semisolid pharmaceuticals are intrinsically difficult to characterise rheologically as they combine liquid and solid properties within one system. Even simple fluids can affect processes such as heat and mass transfer and the rate of dissolution of a dosage form.

 

 

Capabilities

 

  • Method development
  • Method validations / verifications
  • Pharmacopeial testing
  • Release testing
  • Stability testing
  • Investigatory / troubleshooting / problem solving analysis
  • Comparative analysis

 

 

Equipment

 

  • Brookfield LV
  • Brookfield RV
  • U-tube viscometry
  • TA DHR-1

 

 

 


Texture

 

 

Why choose our Texture offering?

 

The structure and character of a formulation, drug product or medical device is vital for consumer acceptance and usage. Through a range of analytical techniques, we can help characterise the structure and mechanical properties of pharmaceutical products and medical devices throughout the product lifecycle from formulation, through stability and release testing. We can offer insights into how these affect functionalities for medical devices and pharmaceutical products.

 

 

Capabilities

 

  • Syringe Functionality, actuation force, penetrability
  • Break force and glide of syringes
  • Bite force for syringes
  • Actuation force of nasal devices
  • Fragmentation and penetrability of rubber stoppers
  • Medical devices
  • Gel and Bloom Strength

 

 

Equipment

 

  • TA.XT Analysers

 

 

 


Specific Surface Area (SSA, BET) and Density

 

 

Why choose our Specific Surface Area (SSA, BET) and Density offering?

 

SSA is dependent on the size of the particles, as well as on the structure and porosity of the material, these features are important for characterisation during screening for API’s and formulations. Understanding moisture adsorption/desorption of APIs and excipients is important during formulation processing, storage and for release.

Density is an important property of pharmaceutical compounds from powders to tablets. We provide a wide range of analytical techniques to determine density across various pharmaceutical compounds.

 

 

Capabilities

 

  • Specific Surface Area
  • Pore size
  • Pore Volume
  • Bulk and Tapped Density

 

 

Equipment

 

  • TriStar II 3020
  • Tapped Density
  • Bulk density
  • Gas Pcynometry
  • Oscillating U-tube

 

 

 


Powder Flowability

 

 

Why choose our Powder Flowability offering?

 

Using our Brookfield powder flow and FT4 Powder Rheometers we can characterise the flow of powder and granular excipients and active pharmaceutical ingredients to aid in manufacturing processes. This technique can be useful in troubleshooting caking and non-uniform flow through hoppers during processing. Our analysts will be able to provide direction on which analytical technique would be suitable for your needs.

 

 

Capabilities

 

  • Flow function and wall friction
  • Hopper design
  • Bulk properties
  • Investigative projects

 

 

Equipment

 

  • Brookfield Powder Flow
  • FT4 Powder rheometer
Involves studying and characterising biological molecules, such as proteins, nucleic acids (DNA and RNA), lipids, and carbohydrates. Biomolecular analysis plays a crucial role in understanding the molecular basis of life, disease mechanisms, drug development, and various biological processes. 

 

 

Polymerase Chain Reaction (PCR)

 

Next Generation Sequencing (NGS)

 

Third Generation Sequencing

 

 


Polymerase Chain Reaction (PCR)

 

Polymerase Chain Reaction (PCR) is a powerful molecular biology technique used to amplify and detect specific DNA sequences in a sample. By repeatedly cycling through a series of temperature changes, PCR can produce millions of copies of a target DNA segment, making it possible to identify and analyze genetic material with high sensitivity and precision. This technique is widely used in applications such as genetic testing, disease diagnostics, and forensic analysis, providing critical insights into genetic information across various fields.

 

Equipment

 

  • BioRad CFX qPCR Detection System
  • Applied Biosystems GeneAmp 9700 PCR Detection System
  • Food & Consumer goods capabilities and applications

    • Animal species ID (Meat/Fish ingredient authentication, foreign body assessment, contaminant assessment, Adulteration assessment)
    • Plant species ID (ingredient authentication, foreign body assessment, contaminant assessment, Adulteration assessment)
    • Vegan and Vegetarian claim substantiation
    • Food Allergen contaminant assessment
    • Genetically Modified Microorganism safety assessment 
    • Genetic barcoding/ typing (verification of important genetic markers, verify origin)
    • Cross contamination assessments
    • Genetically modified organisms (e.g. roundup ready)
    • Microbial ID, typing (e.g. salmonelarla serotype)

Next Generation Sequencing (NGS)

 

Next-Generation Sequencing (NGS) is an advanced technology that enables the rapid sequencing of entire genomes or targeted regions of DNA and RNA. This method allows for high-throughput analysis, producing vast amounts of genetic data in a single run, which can be used for applications such as genomics research, personalized medicine, and mutation detection. NGS provides deep insights into genetic variation, making it a powerful tool for understanding complex biological processes and enabling precision medicine.

 

Equipment

 

  • Illumina MiSeq Short Read Sequencing Platform
  • Applied Biosystems GeneAmp PCR System 9700
  • Agilent 2100 Bioanalyzer 
  • Thermo Scientific Qubit Fluorometer
  • BioTek Spectrophotometer 
  • Ridom SeqSphere+ 
  • Illumina Basespace
  • Various Bioinformatic tools
     
  • Food & Consumer goods capabilities and applications

    • Whole Genome Sequencing (WGS) of small genomes 
    • Microbial based typing methods for relatedness:
      • Core Genome Multilocal Sequence Typing (cgMLST)- high resolution genetic relatedness
      • Multilocal Sequence Typing (MLST)- characterising microbial strains 
      • Salmonella Serotype ID- mid resolution genetic relatedness
    • Microbial contamination assessments using Single Nucleotide Variant assessment (SNV) 
    • Bioinformatic genotyping traits (e.g. Antimicrobial resistance)- safety assessment and monitoring tool.
    • Genus/Species ID (ingredient authentication, foreign body assessment, contaminant assessment, Adulteration assessment)
    • Metagenomics 
    • Traceability assessments 

Third Generation Sequencing

 

Third-Generation Sequencing is an advanced genomic technology that allows for the direct sequencing of single DNA or RNA molecules in real-time without the need for amplification. This technique offers longer read lengths compared to earlier methods, providing a more comprehensive view of complex regions of the genome, structural variations, and epigenetic modifications. Third-generation sequencing is particularly useful in applications like de novo genome assembly, studying large structural variations, and analyzing epigenetic changes, making it a powerful tool for cutting-edge genetic research and precision medicine.

 

Equipment

 

  • Oxford Nanopore (ONT) MinION long read Sequencing Platform
  • Agilent 2100 Bioanalyzer 
  • Thermo Scientific Qubit Fluorometer
  • BioTek Spectrophotometer 
  • Oxford Nanopore (ONT) MinKNOW
  • Various Bioinformatic tools
  • Food & Consumer goods capabilities and applications

    • Whole Genome Sequencing (WGS) of small genomes (e.g. Salmonella)
    • Bacterial typing methods:
      • Multilocal Sequence Typing (MLST)
      • Salmonella Serotype ID
    • Bioinformatic genotyping traits
    • Species ID 
    • Genetic variation