Release testing is a significant component of the quality control process and a critical aspect of drug development, from early-stage through commercial batch release, ensuring bio/pharmaceutical drug substances, drug products, raw materials, and in-process materials comply with established specifications prior to finished product release.
Element offers the highest release testing services through our network of cGMP compliant, ISO/IEC 17025 accredited and DEA licensed laboratories.
What is GMP Pharmaceutical batch release testing?
Element’s comprehensive suite of quality control (QC) lot release solutions apply to all stages of manufacturing, including in-process testing and pharmaceutical process validation testing (revalidation) needs that result from modifications to formulations, new processes, or equipment changes.
Our team of expert scientists have a demonstrated track record of delivering expedient and exacting results for process validation and in-process testing, in addition to release testing in our purposefully equipped GMP laboratories. Rigorous analytical testing services ensure established quality standards and GMP requirements are met prior to the release of manufactured batches of drug product. Compendial methods are followed when available, new test methods can be developed and validated by our knowledgeable team, or existing analytical methods can be easily optimized and transferred.
Key benefits of GMP Pharmaceutical batch release testing with Element
- Expertise & Experience - Our team of expert scientists have a proven track record in delivering accurate, timely results. Their ability to develop, validate, and optimize analytical methods demonstrates their deep knowledge of the industry and commitment to quality.
- Comprehensive Service Offerings - Our wide range of testing services, covering everything from raw materials to finished products. This comprehensive approach ensures that all aspects of drug development are covered, helping to minimize risk and ensuring product quality.
- Compliance & Quality Assurance - Our adherence to rigorous GMP and ISO/IEC 17025 standards guarantees that our testing processes meet the highest industry requirements. This ensures product safety, efficacy, and regulatory compliance.
Overcome analytical challenges
Developing and validating robust analytical methods can be time-consuming and resource-intensive. Additionally, staying updated with the latest compendial and regulatory requirements is challenging. Our team of expert scientists has extensive experience in method development, validation, and transfer. They stay up-to-date with the latest compendial and regulatory changes, ensuring that clients benefit from the most advanced analytical techniques.
Meet tight deadlines and ensure regulatory compliance
GMP lot release testing often involves strict timelines to meet market demands. Additionally, ensuring compliance with complex regulatory requirements can be burdensome.
Our network of cGMP compliant and ISO/IEC 17025 accredited laboratories, coupled with their efficient processes, enables them to deliver results quickly without compromising quality. Their expertise in regulatory affairs helps clients navigate the complex compliance landscape.
Biologics GMP Lot release testing
Before any biologic product can be released for use, sale, or export, lot release testing is necessary to demonstrate the product meets previously established specifications for identity, potency, and purity. Additionally, comparability testing is needed to ensure that each new lot of product is the same as the original batch, and can identify whether any changes made to manufacturing processes have resulted in downstream product quality changes. Regulatory agencies, including the FDA, require a series of analytical tests be performed on drug substance (unformulated active ingredient) and final drug product (formulated drug).
Which modalities can we support?
- Small molecule
- Biologics - therapeutic proteins, monoclonal antibodies
- Cell therapies
- Gene therapies
- Peptides
Why choose Element?
Our industry experts ensure every client receives the Element standard of service that has helped countless organizations bring revolutionary products and therapeutics to market, while meeting both specifications and timelines for raw material, lot or batch release, and distribution.
To learn more about Element’s lot release testing programs for pharmaceuticals and biologics, or to speak with one of our experts, contact us today.
The Industries We Serve
Element offers a diverse, comprehensive suite of customized testing solutions and products for clients in the Antimicrobial, Food Production, Medical Device and Pharmaceutical industries.
Biopharmaceuticals and Biologics Analysis
Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.
Raw Materials and Excipient Testing
Element has comprehensive capabilities that can be applied to the testing of excipient, raw materials, and pharmaceutical containers, enabling you to ensure the quality and safety of your product.
Microbiology Testing
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.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.