Stability and Forced Degradation Testing of Pharmaceuticals and Biologics

Element provides comprehensive stability testing that addresses the intricate challenges of pharmaceutical and biological product development. Our approach spans the entire product lifecycle, from preclinical stages through clinical trials and post-approval studies, ensuring rigorous quality assessment across diverse product types. Our analytical experts deliver robust testing programs that generate high-quality data to support your development milestones while meeting regulatory requirements. 

Our key testing capabilities include: 

• Detailed characterization of drug substances and products 

• Comprehensive analysis of impurities and degradants 

• Evaluation of physicochemical characteristics 

• Assessment of dissolution profiles 

• Examination of disintegration and friability for solid-dose products 

• Analysis of rheology and viscosity for topical formulations 

• Specialized testing for large molecule drug products 

Pharmaceutical Stability Testing: 
Our expert scientists work with clients to create stability programs for drug substances and products, covering impurities, degradants, and changes in physicochemical properties like dissolution and disintegration of solid-dose products, and rheology of topical formulations. Our stability chambers offer 24/7 monitoring with backup generators to ensure continuous testing, supporting a variety of storage conditions, including cGMP-compliant environments for commercial stability studies and expiration dating. 

Our services include: 

• ICH stability testing services 

• Stability-indicating assay development, including forced degradation studies 

• Real-time & long-term stability 

• Accelerated stability 

• In-use studies 

• Beyond-use stability 

• Photostability testing to ICH guidelines 

• Formulation evaluation stability 

• Follow-up stability testing 

• Freeze-thaw stability studies 

• Stress stability testing 

• R&D stability testing 

• Identification of unknown degradants and impurities 

• Registration batch stability testing 

• In-use stability studies 

• Finished product release 

• Sterility and microbiological assessment 

• Container-closure integrity testing 

Biologics Stability Testing: 
Biologic drugs require complex analytical methods due to their environmental sensitivity, batch-to-batch variability, and formulation complexity. Our stability testing programs are tailored to each product, using advanced methods and instrumentation. We focus on identifying degradation pathways and comprehensively evaluating critical quality attributes (CQAs) for biologics like proteins, biosimilars, and antibodies. Our teams conduct forced degradation and long-term stability studies, leveraging a robust library of platform methods to assess impurities and product quality. 

Forced degradation studies: 

At Element, we follow the drug stability guideline Q1A (R2), which involves stress studies on a drug molecule to determine its intrinsic stability characteristics and allows for the identification of degradation products.  

Our experts support stress studies by robust analytical procedures to determine the stability of molecule and help you select proper formulation and package, and provide suitable storage conditions and shelf life for your drug products and drug substances.   

Our services include:  

• Protocol design for degradation studies defined by leading chemists in the field 

• Identification of degradation products 

• Development reports providing a complete history of the forced degradation study design and resulting degradation profiles from all stress conditions 

We have a proven track record of successfully developing dozens of stability indicating assays based on degradation data. 

Element delivers advanced analytical solutions that meet the most complex regulatory requirements. Our comprehensive approach includes detailed testing programs designed to generate the specific data needed for your product, with analytical expertise that addresses your product's unique characteristics. Our comprehensive approach includes: 

• Development of stability-indicating analytical methods 

• Identification of unknown degradants and impurities 

• Specialized analytical techniques for large molecule testing 

• Advanced platform methods for precise product characterization 

• Comprehensive quality attribute evaluation 

• Support for multiple regulatory submission pathways 

• Customized analytical strategies for unique product formulations 

Stability-indicating analytical methods for large molecule stability programs: 

• SDS-PAGE or CE-SDS 

• Western blot 

• Charge heterogeneity (cIEF) 

• Forced degradation studies 

• Stability-indicating chromatography and size-exclusion chromatography (U/HPLC) 

• Spectrophotometry 

• Peptide mapping of proteins and peptides 

• Aggregation analysis by dynamic light scattering (DLS) 

• Total protein quantification by BCA or A280 

• Glycosylation studies 

• Post-translational modifications (PTM) 

• Purity assays 

• Cell-based bioassays and in vitro enzymatic activity assays 

• pH, osmolality, dissolution, and appearance 

• Subvisible particulates and moisture content 

• Active ingredient determination 

• Container-closure integrity 

• Endotoxin, microbial enumeration and sterility testing 

Storage conditions for large molecule stability studies: 

• Cryogenic freezers 

• 25˚C/60% RH 

• 30˚C/65% RH 

• 40˚C/75% RH 

• 30˚C 

• 2-8˚C 

• -20˚C 

• <-60˚C 

Stability program support for regulatory filing pathways: 

• 351(a) Biologics license application (BLA) for innovator biologics 

• 351(k) Pathway for biosimilars and interchangeable biologics 

• NDA (New drug application) 

• 505(b)(1) Investigational new drug (IND) application 

• 505 (b)(2) New chemical entity (NCE) pathway 

• 505(j) Abbreviated new drug product (ANDA) for generic drugs 

• OTC (Monograph-based or IND-based) 

• INAD (Investigational new animal drug) 

• NADA (New animal drug application) 

• ANANDA (Abbreviated new animal drug pathway for generic new animal drugs) 

• CNADA (Conditional approval for new animal drugs) 

Our state-of-the-art testing infrastructure includes: 

• Advanced stability chambers with 24/7 automated monitoring 

• Backup generators ensuring continuous testing capabilities 

• Specialized instrumentation for large molecule analysis 

• Multiple storage condition chambers 

• Precise environmental control systems
• Advanced analytical equipment including: 
  • Dynamic light scattering 
  • Spectrophotometry 
  • Sophisticated chromatography systems 
  • Specialized protein and peptide analysis tools 

• State-of-the-art spectroscopy instrumentation, including: 

• • Quadruple/time of flight tandem mass spectroscopy (Q-TOF)  

• • 500 MHz Nuclear Magnetic Resonance (NMR) equipment 

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences lab on our Locations Page. 

We provide a tailored approach to address the unique challenges of pharmaceutical and biological product development. Our scientific teams execute comprehensive stability testing programs that meet specific regulatory and scientific requirements, ensuring precise and reliable data across various drug development stages. Our rigorous analytical methods help accelerate your path to market by providing the robust stability data needed for successful product development.