GMP Lot Release Testing Services

Ensure consistent product quality and regulatory compliance with our comprehensive GMP lot release testing services. From early-phase development to commercial manufacturing, our FDA-inspected laboratories deliver accurate, compliant testing across all pharmaceutical modalities. Our expert scientists help accelerate your time to market while maintaining the highest quality standards for your pharmaceutical products.

Expert conducting GMP Lot Release Testing

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What are GMP Lot Release Testing Services at Element?

Release testing is a significant component of the quality control process and a critical aspect of drug development. GMP lot release testing validates drug substances, products, raw materials, and in-process materials against established specifications. At Element, we deliver comprehensive release testing services through our network of cGMP compliant, ISO/IEC 17025 accredited, FDA-inspected, and DEA licensed laboratories, supporting your product development from early-stage through commercial batch release.

Element life sciences testing expert in lab

What Can Element Offer You For GMP Lot Release Testing Services?

Key tests offered

We provide comprehensive quality control testing tailored to your specific requirements.

Our range of services:

Comparability testing
Method development, validation, qualification and transfer
Compendial and pharmacopoeia monograph tests (USP/NF, JP, EP, FCC, BP)
Identity (SDS-PAGE, Western blot, immunologic assay, ELISA)
Peptide mapping
Protein concentration
Potency
Cell-based bioassays
Purity
Product and Process related impurities
Determination of host cell protein (HCPs), host cell DNA
Physicochemical properties
Microbiology and sterility testing
Stability testing

Our range of GMP pharmaceutical services:

Method development, validation, qualification and transfer
Compendial and pharmacopeia monograph tests (USP/NF, JP, EP, FCC, BP)
Physical and chemical analysis
Identity
Potency and purity
Impurity testing
Related substances
Uniformity
Particulate matter
Limit tests
Residual solvent testing
Dissolution testing
Physicochemical properties
Microbiology and sterility
Heavy metals testing
Extractables and leachables
Stability testing

Which modalities can we support?

Small molecule drugs
Biologics and biosimilars
Therapeutic proteins
Monoclonal antibodies
Cell therapies
Gene therapies
Peptides

Products and materials we test

Our extensive testing capabilities support your entire product development lifecycle, from raw materials and excipients to drug substances and finished pharmaceutical products. We deliver comprehensive testing across multiple modalities, including small molecules, biologics, cell therapies, gene therapies, and peptides. Our testing solutions apply to all stages of manufacturing, including in-process testing and pharmaceutical process validation testing needs that result from modifications to formulations, new processes, or equipment changes. Our purposefully equipped GMP laboratories help you maintain consistent quality throughout your manufacturing process.

Methods and solutions offered

Access complete method development, validation, qualification, and transfer services aligned with global pharmacopeia standards. We support all major compendial testing requirements (USP/NF, JP, EP, FCC, BP) and can develop or optimize custom analytical methods to meet your specific needs. Our experienced scientists work closely with you to establish robust testing protocols that withstand regulatory scrutiny. When compendial methods aren't available, our knowledgeable team can develop and validate new test methods or optimize and transfer your existing analytical methods, providing you with flexible solutions for your testing requirements.

Our validated methods deliver reliable results that support your regulatory compliance needs through:

Identity verification and potency analysis
Purity assessment and impurity testing
Related substances analysis
Uniformity evaluation and particulate matter analysis
Limit tests and residual solvent testing
Dissolution studies
Complete physicochemical properties characterization
Analysis of production changes and out-of-specification test results

Which labs offer this service

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

Biologics expertise

Our specialized biologics testing capabilities support your biological product development with industry-leading expertise and advanced analytical methods, including:

Comparability testing
Identity verification through SDS-PAGE and Western blot
Peptide mapping and protein concentration analysis
Cell-based bioassays
Comprehensive purity testing
Host cell protein and DNA analysis

Standards we test to and products we test

These are our most prevalent requests. Don't see what you're looking for? Contact us!

USP/NF
JP (Japanese Pharmacopeia)
EP (European Pharmacopeia)
FCC
BP (British Pharmacopeia)

Your Challenges, Our Solutions

Quality compliance made seamless

Our cGMP compliant and ISO/IEC 17025-accredited, and FDA-registered laboratories deliver testing that exceeds regulatory requirements, supported by experts who maintain current knowledge of evolving industry standards. Our rigorous analytical testing services validate that your manufactured batches meet established quality standards and GMP requirements before release.

Accelerated timelines without sacrificing quality

Our efficient processes and dedicated team of experts deliver rapid results without compromising quality, helping you meet demanding production schedules and market requirements while maintaining the highest testing standards.

Advanced analytical solutions delivered

Our experienced scientists handle all aspects of method development, validation, and transfer, providing you with robust, reliable testing methods that save time and resources while delivering consistent results. They also excel at analyzing production changes and investigating out-of-specification test results, demonstrating their deep industry knowledge and commitment to quality in every analytical challenge.

Testing expertise you can rely on

Our testing services adhere to current compendial and regulatory requirements, keeping your testing program current and compliant. Our global testing capabilities ensure your products meet established quality standards across all major markets.

Why Choose Element

Element scientist in white lab coat working in life sciences testing laboratory

Comprehensive testing network

Access our network of laboratories for convenient, consistent testing support.

Expertise & Experience

Our team develops, validates, and optimizes analytical methods with a deep knowledge of the industry and a commitment to quality.

Comprehensive Service Offerings

Our comprehensive approach ensures that all aspects of drug development are covered, helping to minimize risk and ensuring product quality.

Compliance and Quality Assurance

Our adherence to rigorous GMP and ISO/IEC 17025 standards guarantees the highest industry requirements for product safety, efficacy, and compliance.

Frequently asked questions

What testing capabilities does Element offer for pharmaceutical products?

Our comprehensive GMP lot release testing includes identity, potency, purity, impurity testing, physicochemical properties, stability testing, and more. We support all major modalities including small molecules, biologics, cell therapies, gene therapies, and peptides.

Can Element help with stability testing as part of our lot release program?

Yes, stability testing is one of our core services. We execute stability studies that comply with ICH guidelines and help establish appropriate shelf life and storage conditions for your products.

How does Element handle out-of-specification test results?

Our experts follow a comprehensive investigation protocol when out-of-specification results occur, including thorough root cause analysis, retesting when appropriate, and detailed documentation to support your quality requirements and help improve your manufacturing processes.