Raw Material, In-Process & Lot Release Testing services
Need reliable pharmaceutical testing that keeps your development timeline on track? Our comprehensive raw material testing and lot release services help you navigate complex regulatory requirements while maintaining rapid testing cycles. Partner with Element's consultative scientists to ensure your products meet specifications and reach market faster.
What is raw material and lot release testing at Element?
Raw material and lot release testing verifies the identity, purity, and potency of pharmaceutical materials throughout development and manufacturing. At Element, we provide comprehensive testing services from early-stage development through commercial manufacturing, ensuring your products meet all regulatory requirements and specifications before release.
What can Element offer you for raw material and lot release testing?
Components and materials we test
Components and materials we test
We test a complete range of pharmaceutical materials including APIs, excipients, drug substances, and finished products. Our testing capabilities cover both small and large molecule products, with specialized expertise in biologics testing where we verify purity, concentration, consistency, identity, and biosafety requirements.
Key tests offered
Key tests offered
Raw Material Release Testing:
Element ensures raw materials and APIs meet 21 CFR 211.84 requirements before use in manufacturing. Our raw material testing confirms both the identity and integrity of materials, ensuring you’ve received the right product that meets established specifications for its intended use. We offer comprehensive testing services throughout the drug development lifecycle, from early-stage to commercial production. Our experts use advanced analytical techniques, like Raman spectroscopy, to rapidly identify materials, reducing cycle time. We also verify, transfer, optimize existing methods, or develop and validate new release testing methods as needed.
In-Process and Pharmaceutical Batch Release Testing:
Element offers a comprehensive suite of quality control solutions, including in-process testing, pharmaceutical process validation, and revalidation following changes to formulations, processes, or equipment. Our expert scientists provide rapid, precise results in GMP labs, ensuring all quality standards and GMP requirements are met before batch release. We can develop, validate, or optimize new and existing analytical methods tailored to each biopharmaceutical product.
Comparability and Biologic Drug Batch Release Testing:
Before release, biologic products must undergo lot release testing to confirm identity, potency, and purity. Comparability testing ensures new batches match original specifications and identify any manufacturing changes affecting product quality. Element’s experts help you navigate regulatory requirements, considering the product’s complexity, manufacturing process, and the reliability of analytical methods for identity, purity, and potency testing.
GMP material and lot release testing services:
- Method development, validation, qualification, and transfer
- Compendial and pharmacopoeia monograph tests (USP/NF, JP, EP, FCC, BP)
- Physical and chemical analysis
- Identity
- Potency and purity
- Impurity testing
- Formulation verification
- Related substances
- Uniformity
- Particulate matter
- Limit tests
- Residual solvent testing
- Dissolution testing
- Physicochemical properties
- Presentation (syringe and vial volume, excipient concentration)
- Microbiology tests and assays
- Heavy metals
- Endotoxin testing (sterile and non-sterile products)
- Container-closure qualification (extractables and leachables)
Biologics material and release testing services:
- Comparability testing
- Method development, validation, qualification and transfer
- Compendial and pharmacopoeia monograph tests (USP/NF, JP, EP, FCC, BP)
- Protein purity and related proteins
- Peptide mapping
- Impurities
- Identity (SDS-PAGE, Western blot, immunologic assay, ELISA)
- Purity (HPLC, SDS-PAGE, moisture, endotoxin, ELISA)
- Potency (immunogenicity, antigen content or chemical composition)
- Protein concentration
- Amino acid analysis
- Residual contaminant testing
- Determination of host cell protein (HCPs)
- Cell-based bioassays
- Physicochemical properties
- Microbiology tests and assays
- Sterility testing
Methods and solutions offered
Methods and solutions offered
Our CMC experts provide full-service chemistry, manufacturing and controls (CMC) and QC solutions built on proven success in developing, validating, and transferring sophisticated analytical methods.
- Method development and validation
- Method transfer and qualification
- Compendial testing (USP/NF, JP, EP, FCC, BP)
- Custom analytical method development
- Process validation testing
- Comparability testing for biologics
Cutting-edge equipment we use
Cutting-edge equipment we use
- Raman spectroscopy for fast identification
- Advanced analytical instrumentation (HPLC, SDS-PAGE)
- Purpose-equipped GMP laboratories
Which labs offer this service
Which labs offer this service
Our experts have decades of E&L experience and knowledge and are active in standards development. As they help shape industry best practices, they apply this cutting-edge knowledge to our customers’ studies. Element has one of the largest and most comprehensive extractables reference library in the industry. Our customers leverage our extensive specialized testing expertise for complex products, including OINDP, combination products, and cell therapies.
Materials we test
Pharmaceutical Materials:
- APIs
- Excipients
- Drug substances
- Drug products
- Raw materials
- In-process materials
Biologics Materials:
- Unprocessed bulk materials
- Purified bulk materials
- Large molecule products
- Host cell proteins
- Reference standards
Your Challenges, Our Solutions
Complex Regulatory Requirements
Time-Critical Testing Needs
Multiple Testing Requirements
Manufacturing Process Changes
Why Choose Element
Comprehensive Expertise
End-to-End Support
Advanced Technology
Customized Solutions
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Frequently asked questions
What types of raw material testing do you provide?
We offer comprehensive testing including identity, potency, purity, impurity testing, and physicochemical analysis, all compliant with 21 CFR 211.84 requirements
How do you ensure testing meets regulatory requirements?
Our consultative scientists are well-versed in regulatory guidance and utilize established specifications that comply with 21 CFR Parts 210 and 211.
What specific biologics testing services do you offer?
We provide comprehensive biologics testing including protein purity analysis, peptide mapping, identity testing (SDS-PAGE, Western blot, immunologic assay, ELISA), cell-based bioassays, and determination of host cell proteins (HCPs).
What factors influence the complexity of biologics testing requirements?
Testing complexity is primarily influenced by two key factors: the product indication and the source and level of control of raw materials used. Our experts consider these along with chemical complexity and manufacturing processes when designing testing programs.
How do you handle method transfer and validation?
We can verify existing test methods, develop and validate new methods, or transfer and optimize your current analytical methods. Our approach is flexible and adapts to your specific needs while maintaining regulatory compliance.
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