Physical, chemical or microbiological changes can affect the safety and efficacy of your biopharmaceutical, so it is essential to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity or light. This will allow you to establish the shelf life of your drug product and recommend its storage conditions.

RSSL offers comprehensive and cost-effective stability management, in accordance with GMP and ICH guidelines, providing a quality service to meet your specific storage and testing needs.

Stability Storage

RSSL’s expert biopharmaceutical stability services include a range of monitored temperature, humidity, and light stability storage cabinets which comply with ICH Guidelines, covering requirements for climatic zones I to IV.

Our stability storage conditions include:

  • -80°C and -20°C
  • 5°C
  • 25°C/60% RH
  • 30°C/65% RH
  • 30°C/75% RH
  • 40°C/75% RH

Our 21CFR compliant storage facilities are secure, fully validated and maintained. They are monitored 24 hours a day, with a dedicated out-of-hours response team on call in case of emergency.

Stability Testing

Stability testing for biological molecules needs to be carried out at multiple points in the development cycle. RSSL can offer flexible solutions to fit all your needs including:

  • Early stage stress and accelerated studies on drug product
  • Pre-formulation batches
  • Scale up batches
  • Registration batch accelerated and long term
  • Ongoing and follow up stability tests
  • In-use stability

In addition, we can offer other specific studies, such as photostability, shear stress, freeze thaw and accidental freezing, and temperature cycling for excursion. The tests carried out during these stability studies will vary, but as a minimum will generally include:

  • Pharmacopeia  – appearance, pH, UV, particulate
  • SDS PAGE, IEF, Western blots
  • Chromatographic Profiles (SEC, IEX, HI, RP, CE)
  • Functional assays
  • Mass spectrometry - peptide mapping and intact and reduced mass
  • Safety – bioburden sterility, endotoxin

Whatever tests are selected, they must be able to detect changes in the identity, purity and potency of your product. RSSL can offer everything required to achieve this, as well as method development and validation to monitor the changes listed in ICH Q5C:

  • Deamidation – hydrolysis of Asn and Gln side chain amides
  • Oxidation – of Met, His, Cys, Tyr amnd Trp residues
  • Denaturation – loss of 3-D structure
  • Aggregation – association of monomers or native multimers covalent or non covalent
  • Glycoproteins – most common instability of glycosylation hydrolysis of sialic acid residues.

From protocol preparation to the issue of final reports, we offer comprehensive project management, plus advice and support. We can also offer full programmes for method transfer if you already have established methods.

Please contact us to ensure your assays are fit for purpose and stability indicating.

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