Proteins & Peptides Extractables and Leachables Analysis

Extractable and leachable (E&L) studies are critical to the safety and efficacy of protein/peptide biologics. CD Formulation provides biopharmaceutical companies with powerful E&L solutions to ensure that a variety of protein/peptide biopharmaceutical products meet stringent quality and safety standards. Our services range from method development and validation, United States Pharmacopeia (USP) <661>, USP <661.1> <661.2>, <665>, regulatory support, material characterization, and risk-based approaches to extractable and leachable testing.

The Importance of Extractables and Leachables Analysis

• Extractables: Compounds that are released or extracted from any material that comes into contact with a drug product (including elastomers, plastics, glass, stainless steel, or coating components) under specific conditions (such as temperature, solvent exposure, or other stressors). These conditions simulate the intended use or processing of the product.
• Leachables: A subset of extractables, compounds that migrate from any product contact material (including elastomers, plastics, glass, stainless steel, or coating components) into the product during normal use (such as normal processing conditions or accelerated storage conditions). These substances are likely to be present in the final drug product and pose a risk to the safety and efficacy of the final product.

Leachables are chemical compounds that migrate from container closure systems, packaging materials, or medical devices into drug products over time under normal storage conditions or during the intended use of the product. Unlike extractables found in controlled studies, leachables are detected in actual drug products, and their presence may be a concern if they exceed acceptable safety levels.

Fig. 1 Relationship between extractables and leachables. (CD Formulation)

Conducting E&L studies helps pharmaceutical companies perform:

• Ensure safety: Extractables and leachables analysis helps identify and quantify potentially harmful compounds that may leach into drug products, ensuring that the drug product is free of contaminants, thereby preventing adverse effects on patients.
• Process optimization: Extractables and leachables analysis can help improve manufacturing processes. By identifying and eliminating potential sources of contamination, manufacturers can improve the overall quality of their products.
• Study design: E&L studies begin with careful planning. Exposure conditions for the product or material should be defined. Analytical methods and acceptance criteria appropriate for the target compounds should be selected and established.
• Product quality: Extractables and leachables can impact the quality of drug products. For example, in biopharmaceuticals, some heavy metals migrate from packaging materials into the drug product, causing protein denaturation.
• Regulatory compliance: Regulatory agencies such as the FDA and EMA require pharmaceutical companies to conduct thorough E&L studies during the drug approval process. Compliance with these regulations is critical to gaining market approval for new drugs.

Explore Our Proteins & Peptides Extractables and Leachables Analysis Services

At CD Formulation, our scientists are experts in identifying and analyzing any extractable and leachable in protein and peptide biologics. We offer a comprehensive range of extractables and leachables testing methods, backed by expertise from decades of analytical experience. Our well-trained and experienced E&L team can assist you at every stage, ensuring successful regulatory submissions.

We work with our clients to provide tailored E&L studies based on the product's stage of development deliver meaningful extractable data and assist them in risk assessments of their product configurations or manufacturing chains.

Our extractable studies can be designed in accordance with guidelines such as USP <665>, <1663>, and <1664>. These studies meet the expectations of the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), Europe, Middle East, and Africa (EMEA), and other regulatory agencies.

Available Testing Items Include:

• Extractable, simulated, and migration studies.
• Further structural elucidation is based on MS/MS fragmentation capabilities.
• Non-volatile compound analysis by high-resolution accurate mass spectrometry instrumentation.
• Compound identification and molecular formula generation using accurate mass and isotope spacing information for any previously unknown ionizable compounds.
• Extractable and leachable method development and validation.
• Leachable stability testing and storage studies.
• Semi-volatile compound analysis by direct injection GC-MS and volatile compound analysis by headspace sampling GC-MS.
• Development of custom study designs for extractables and leachables based on drug product specifications.
• Leachable studies or simulated use studies on finished products and dosage forms.
• Existing reports and evaluation results are based on current guidelines.
• Extractable and leachable risk assessment.
• Total organic carbon (TOC) analysis.
• Toxicological evaluation of extractable and leachable data.
• Biocompatibility testing such as USP <87> and <88>.

Our Extensive Expertise

• Container/closure components for a wide range of biological product types.
• Injectable components such as container closure systems (stoppers and vials), syringes, and devices.
• Container closure components including labels, foils, adhesives, and films.
• Manufactured components (e.g., filters, tubing, manifolds, gaskets, seals).
• Parenteral, ophthalmic, dermatological, topical, oral inhalation and nasal drug products, metered dose inhalers.

Our Analytical Technologies

Our analytical laboratories are equipped with the most advanced technologies to analyze extraction solutions using a variety of state-of-the-art equipment including GC/MS, GF-AAS, HPLC-UV/MS, ICP/MS, and ICP-OES.

Additional Extraction and Characterization Technologies

Applicable Standards

• EP
• USP
• ISO
• ICH

Why Choose Us for Proteins & Peptides Extractables and Leachables Analysis?

• We have extensive experience and achievements in performing E&L testing.
• We have the industry-leading expertise to recommend testing protocols that meet current industry standards and meet regulatory requirements.
• We provide a toxicological evaluation of extractable and lreachable data.
• All our E&L methods are validated to ensure accurate results and meet regulatory requirements.
• We offer flexible test design options and customized solutions.
• We have a wide range of analytical techniques and equipment to identify and quantify extractable and leachable in a variety of sample matrices.
• We adhere to strict quality standards and regulatory guidelines to ensure that all testing is conducted in accordance with industry best practices.

Publication

Extractables and leachables testing are critical components to ensure safety, efficacy, and consistency in the development and manufacture of therapeutic proteins and peptides. Please feel free to contact us if you are interested in our services. Learn how CD Formulation can help you conduct extractable and leachable testing and verify the safety of your products in relation to regulatory requirements.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.