Element blends regulatory acumen and an “always available” mindset to provide unmatched quality, compliance and customer service to support the expedient release of small and large molecule finished products in addition to the qualification of raw materials, APIs, excipients, intermediates, starting materials, cell banks, vectors, bulk harvest materials and control cells.
Testing and compliance to the standardized methods and specifications detailed within pharmacopeial compendia is a basic requirement for manufacturing release and distribution of biopharmaceutical ingredients and drug products around the world. Compendial methods may be implemented as part of routine quality control strategies, in addition to addressing anticipated regulatory concerns, and/or establishing general drug compatibility.
Element offers comprehensive compendial testing programs that meet specifications in the US Pharmacopoeia-National Formulary (USP/NF), European Pharmacopoeia (EP), British Pharmacopoeia (BP), the Japanese Pharmacopoeia (JP), and those that are set by the International Council on Harmonisation (ICH). Our compendia release testing solutions support a variety of drug products, including over the counter and generic drugs, pharmaceuticals, biologics and biosimilars, combination products, innovative and novel products and animal drug products. All compendial testing is performed per cGMP standards of 21 CFR 210 and CFR 211.
The Element advantage
Element offers a seamless partnership, providing full access to our consultative, technical team of CMC experts with extensive knowledge of regulatory requirements and years of experience testing a wide range of materials and drug products to USP compendial methods and FDA monographs. Bring safe and efficacious products to market expeditiously with a robust and effective quality control strategy that incorporates our comprehensive compendial and monograph testing services.
To learn about our compendial testing services for OTC drugs, generic drugs, pharmaceuticals, biologics, and biosimilars, or to speak with one of our experts, contact us today.
- Full monograph testing (USP/NF, EP, JP, BP)
- Compendial method validation (USP <1255>)
- Compendial method verification
- Raw material testing (USP/NF, EP, JP, BP)
- ICH stability studies (API and finished products)
- Stability indicating assay and related substances methods
- Physicochemical testing
- Specific gravity (USP <841>)
- Injectables (USP <1>)
- Loss on Drying (USP <731>)
- Stability studies (ICH Q1A-E)
- Dissolution studies (USP <711>)
- Particle size distribution determination
- Methods verification (USP <1226>)
- General identification tests (USP <191>)
- Identification and quantitation (USP <621>)
- Spectrophotometric analyses (USP <197>)
- Metals and elemental impurities (USP <232, 233>, ICH Q3D)
- Impurities and residual solvents (USP <467>)
- Melting range or temperature
- Uniformity of dosage (USP <791>)
- Container-closure qualifications
- Microbiological testing
- Bioanalytical guidance ICH M10 (Draft) and FDA Bioanalytical Method Validation Guidance for Industry
- FDA Guidance for Industry Potency Tests for Cellular and Gene Therapy Products
- Adventitious agent viral QPCR (USP <1126, 1127>, EP 2.6.7)
- QPCR assays (USP <12269, 1227>, EP 2.6.21)
- Osmolarity, pH, DLS (USP, EP)
- Impurities in Drug Substances and Drug Product (USP <1086>)
- In vitro bioassay determination of biopotency
- In vitro biological reactivity tests
- Pyrogen test
- Acute toxicity
- Cytotoxicity (USP <87>)
- Ancillary (USP <1043>)
- Mycoplasma detection assays (USP <63>, EP 2.6.7, JP)
- Mycoplasma clearance studies
- Physical compendial testing (USP, EP)
- Quantitative purity and impurity analyses
- Process impurities (USP <467>, USP <232, 233>, ICH Q3D)
- Bacterial endotoxins (LAL) tests
- LAL validation (inhibition and enhancement test)
- Microbial limits test (MLT)
- Microbial enumeration test (MET)
- Total aerobic microbial count (TAMC)
- Total combined yeasts and molds count (TYMC)
- Specified microorganism tests
- Antimicrobial effectiveness test (AET)
- Monocyte-activation test
- Bioburden (USP <61>)
- Sterility (USP <71>, EP 2.6.1, EP 2.6.12)
- Endotoxin (USP <85>, EP 2.6.12)
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
Element offers a diverse array of microbiology testing services and can serve clients from early-stage antimicrobial product development and non-GLP screen testing all the way through GLP testing for submission.
Reference Standard Characterization & Management
Element's complete reference standard management program supports small molecule drugs, biologics and biosimilars.