Raw Material, In-Process & Lot Release Testing

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 biopharmaceutical drug substances, drug products, raw materials, and in-process materials comply with established specifications prior to finished product release.

These established specifications are necessary to demonstrate that the product complies with applicable regulatory requirements, including 21 CFR Parts 210 and 211, as well as to confirm purity, identity, and potency. For biologic products, purity, concentration, consistency, identity, and biosafety must be verified. Element’s consultative scientists are well-versed in the interpretation of data for developing product specifications, possess a deep wealth of regulatory guidance, and utilize a wide range of advanced analytical technology and methodology.

Raw material release testing

Any raw material or active pharmaceutical ingredient (API) is required to meet the criteria outlined in 21 CFR 211.84 before it can be used in any manufacturing process or formulation. Raw material testing confirms both the identity and integrity of the material, ensuring that the right product has been received and that it meets the specifications that have been established for its intended use. Element’s raw material testing supports the entire drug development lifecycle, from early-stage development to commercial manufacturing, with a comprehensive suite of services including specification and characterization testing for vendor qualification and the release of APIs and excipients used in manufacturing. Our team of raw materials testing experts make use of a wide range of advanced analytical techniques and instrumentation, including fast identification such as Raman spectroscopy, significantly reducing testing cycle time. Additionally, monograph and compendial methods can be verified, existing test methods can be transferred, verified, and optimized, or alternative raw material release methods can be developed and validated.

In-process and 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 consultative teams 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. Our CMC experts design thorough quality control lot release testing programs customized to meet the individual needs and specifications of each specific biopharmaceutical product tested. 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 transferred, verified, and optimized.

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)

Comparability and biologic drug batch 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 unprocessed and purified bulk materials for each lot of large molecule product produced, however, the complexity of testing required is influenced by two key factors, the product indication and the source and level of control of raw materials used.

Element’s consultative team of expert scientists have the depth of regulatory and industry knowledge to help you confidently navigate the regulatory requirements for biologic product material and release testing program design, considering several factors, including chemical complexity, manufacturing processes, and the reliability and complexity of analytical methods used to evaluate the identity, purity, and potency of materials.

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

The Element advantage

Our regulatory and industry experts ensure every client receives the Element standard of regulatory guidance that has helped countless organizations bring revolutionary small and large molecule drug products and therapeutics to market, while meeting both specifications and timelines for raw material, lot or batch release, and distribution. With Element as your CDMO partner throughout the drug discovery and development process, confidently meet Agency expectations with our full-service chemistry, manufacturing, and controls (CMC) and QC solutions that include reference standard characterization and management , built upon a foundation of proven success in developing, validating, and transferring sophisticated, complex, and challenging analytical methods.

To learn more about Element’s quality control raw material and lot release testing programs for pharmaceuticals and biologics, or to speak with one of our experts, contact us today.