Protein Characterization Services

Our primary structure analysis confirms the identity and functionality of your protein by determining its amino acid sequence and molecular weight. This foundational step ensures your protein is as expected and fully prepared for downstream applications.

Techniques Offered:

• De Novo Sequencing: Accurately determine the amino acid sequence, including variants and post-translational modifications (PTMs).
• Mass Spectrometry (MALDI, LC-MS): Validate the protein identity and molecular weight, ensuring purity and structural integrity.
• Western Blot: Confirm the presence and functionality of specific sequences or tags within your protein.

To verify the biological activity and efficacy of your protein, understanding its post-translational modifications (PTMs) is crucial. We help you ensure that all modifications are correctly performed, which can significantly impact therapeutic properties and stability.

Techniques Offered:

• Peptide Mass Fingerprinting (PMF): Detect glycosylation sites and PTMs using enzymatic digestion and mass spectrometry.
• HILIC-HPLC: Analyze glycans and hydrophilic peptides, ensuring structural integrity and functionality.
• LC-MS / Glycan Profiling: Identify glyco-, phospho-, and other isoforms, ensuring the accuracy of your protein’s modifications.

We evaluate the folding and higher-order structures of your protein to confirm its biological activity and stability. Proper folding is essential to ensuring the correct function and long-term performance of your biopharmaceutical.

Techniques Offered:

• Circular Dichroism (CD): Assess secondary structure and folding, ensuring the protein’s functional conformation.
• NanoDSF: Monitor conformational changes and determine the protein’s melting temperature, providing insight into stability.
• Crystallization: Enable 3D structure determination to provide a detailed view of the protein’s architecture for further development.

We help you evaluate your protein’s stability, solubility, and aggregation state to avoid potential issues during formulation development and storage. This ensures your protein retains its functional integrity under different conditions.

Techniques Offered:

• Dynamic Light Scattering (DLS): Measure size distribution and aggregation in solution, ensuring your protein remains soluble and stable.
• SEC-MALS: Confirm the absolute molecular weight and oligomeric state, verifying the structure and purity.
• Accelerated Stability / Thermal Shift Assays: Track degradation or conformational shifts over time, ensuring stability under various conditions.
• Solubility Profiling (Visual / DLS): Assess protein behavior in different buffers, ensuring optimal solubility and formulation conditions.

Precise quantification of your protein’s yield, activity, and endotoxin levels is essential to ensure both product consistency and safety. Our methods provide reliable and accurate measurements that support your protein’s development process.

Techniques Offered:

• UV Absorbance (A280): Measure protein concentration, ensuring accurate dosing in formulations.
• BCA / Bradford Assay: Alternative methods to measure protein concentration with high accuracy.
• LAL Test: Quantify bacterial endotoxins, ensuring your protein is safe for in vivo studies or cell culture.
• ELISA: Quantify specific protein concentration or activity, confirming functional integrity.

We help you confirm the purity of your protein product by detecting contaminants, degradation, and unwanted forms. Ensuring high purity is crucial for both regulatory compliance and the therapeutic success of your protein.

Techniques Offered:

• SDS-PAGE: Detect size variants, degradation, and confirm purity, ensuring product consistency.
• SEC-HPLC: Separate monomers, dimers, and aggregates, confirming the integrity of your protein.
• Mass Spectrometry: Detect minor contaminants or truncations, ensuring the highest quality product.
• Sterility Testing (Membrane Filtration): Ensure the absence of microbial contamination when required for your application.

We offer a wide range of advanced techniques including Size-Exclusion Chromatography (SEC), Dynamic Light Scattering (DLS), Mass Spectrometry (MS), Circular Dichroism (CD), and Surface Plasmon Resonance (SPR). Each technique is carefully selected to meet the specific needs of your protein and stage of development.

Yes, we offer tailored protein characterization plans that are customized based on your protein type and development stage. Our team works with you to determine the best approach for your specific needs, ensuring that each step of the process aligns with your goals and regulatory requirements.

At ProteoGenix, we use validated analytical methods and state-of-the-art equipment to ensure the highest quality data. Our team follows standardized protocols and performs rigorous quality control at every step of the characterization process, ensuring that the results are both accurate and reproducible for regulatory compliance.

Our turnaround times vary depending on the complexity and type of analysis required. On average, most protein characterization results are delivered within 2-4 weeks. For more urgent projects, we can accommodate accelerated timelines. We provide clear timelines during project scoping and keep you updated on progress.

Yes, we provide customized solutions for every stage of your biopharmaceutical development. Whether you’re in early-stage discovery or advancing to CMC/comparability studies, our team tailors the characterization techniques to meet your specific project goals and regulatory requirements

We rely on advanced technologies that were developed with regulatory expectations in mind. For example, our Verified In-Situ Plate Seeding (VIPS™) system was specifically created to meet FDA and EMA requirements for demonstrating monoclonality—an essential step in preparing cell lines for pre-clinical studies. This ensures that when regulatory compliance is critical, we can provide the right tools and data to support your submissions.

Absolutely! Our team has extensive experience in handling proteins with post-translational modifications (PTMs) and unusual structural features. We offer specialized techniques such as Mass Spectrometry (MS) and HPLC to analyze and confirm PTMs, ensuring your protein meets the required standards for development and regulatory approval.

ProteoGenix offers a tailored, personalized approach that aligns with your specific protein type and development stage. Unlike in-house testing or other CROs, we provide flexible solutions, regulatory expertise, and cutting-edge technologies that ensure reliable and compliant results. Our team works closely with you to understand your project’s unique needs and deliver customized, high-quality data.

Yes, we offer direct consultations with our experts to discuss your protein characterization needs. We believe in a collaborative approach and will work with you to design the most effective analytical plan for your project before moving forward.