Biopharma ACD Service - Veeda Lifesciences

Biosimilars

We provide a full range of comparability, characterization, and biosimilar testing services to support the development of your biosimilar. We offer customized biosimilar solutions for every stage of the biosimilar drug development process.

At Veeda Life Sciences, we understand that the development and manufacture of any biosimilar can be complicated. Our multidisciplinary team has years of experience in characterizing the structural and physicochemical attributes of originators and biosimilars of many different classes of molecules.

We know the hurdles that can be encountered from early development through to multi-batch comparability studies and routine manufacturing. Working with Veeda Life Sciences, you will feel confident that your development decisions are based on quality data from a trusted CRO partner.

Biosimilar Drug Product development

Analytical scientists at Veeda Biopharma have been providing biosimilar comparability testing for decades, so we understand the complex process required to fulfill the regulatory requirements. We offer a comprehensive range of structural, biophysical, and physicochemical characterization methods, drawing on years of technical expertise and product insight to tailor these to your needs.

Structural and physicochemical characterization to ICH Q6B
Comparability studies
Biosimilarity studies
Forced degradation studies
Stability studies
Product impurity analysis and quantitation, including HCP-MS.
Process Related Impurities and
Residual Analysis

An efficient and robust bio-similarity/comparability strategy is crucial for the successful development of a biosimilar. Veeda provides you with expert reports, allowing you to demonstrate structural similarity to the regulators.

Our Approach to Biosimilar Testing

Working with our scientists, you get the support you need with every step of your biosimilar development process:

Originator product characterization
Analytical support for clone selection and process development
Comprehensive physicochemical characterization to demonstrate bio similarity
Method development, optimization and routine analysis
Ongoing consultancy from our scientists to put our structural characterization data into context and support your regulatory package

Biosimilar Experience

Our scientists have a deep understanding of the structure of many different molecule classes and have been involved in hundreds of biosimilar characterization and comparability projects, helping clients accelerate the development of their product

Class

Molecule

Monoclonal Antibodies

Adalimumab, Trastuzumab, Rituximab, Cetuximab, Nivolumab, Pembrolizumab, Infliximab, Bevacizumab, Natalizumab, Ocrelizumab, Vedolizumab, Tocilizumab, Eculizumab, Golimumab, Ustekinumab, Paliviumab, and more

Antibody Drug Conjugates (ADCs)

Gemtuzumab ozogamicin (Mylotarg), Brentuximab vedotin (Adcetris), and Trastuzumab emtansine (Kadcyla)

Fusion Proteins

Aflibercept, Etanercept, and Abatacept

Fab fragments

Ranibizumab and Certolizumab

Hormones

Teriparatide, Parathyroid hormone (PTH), Erythropoietin (EPO), Darbepoetin (DPO), Insulin and insulin analogs, Human Growth Hormone (hGH), PEG-hGH, and more

Peptides

Semaglutide, Glatiramer acetate, Linaclotide, Liraglutide, Teriparatide, Exenatide, Lanreotide, and more

Cytokines

Filgrastim and PEG-Filgrastim, Interferons and PEG-Interferons, Interleukins and more

Other

Low Molecular Weight Heparins (LMWH) and more

Biopharmaceuticals

We provide a one-stop shop service for the structural and physicochemical protein characterization requirements of many different molecule types, supporting the development of biologics, biosimilars, and other large molecules. Our highly skilled scientists at Veeda Biopharma have decades of experience in the structural characterization of biopharmaceuticals. We have been applying our cutting-edge analytical techniques and instrumentation to the analysis of complex biologics for over four decades. Whether your project is to characterize the structure of your molecule, assess its purity (including assessments of product and process residuals), or troubleshoot specific issues, we can assist you throughout your development.

We are trusted by leading biosimilar companies globally, offering specialized biosimilar pharmaceuticals testing expertise.

Examples Of Biopharmaceuticals Analyzed
By Veeda Biopharma

Recombinant/ novel (Glyco)proteins (including recombinant vaccines)

Monoclonal antibodies

Antibody Drug Conjugates (ADCs)

Biosimilars

Biopharmaceutical Testing

Structural and physicochemical characterization is an essential part of biopharmaceutical product development to ensure the correct manufacture of the target drug. Regulatory agencies have set out guideline expectations for the protein characterization methods to be performed, specifically adopting the approach outlined in ICH Topic Q6B.

The specific characterization tests employed vary from product to product, and alternative approaches may be appropriate in many cases. Veeda Biopharma is a pioneer of new and emerging analytical methods, with the ICH guidelines recognizing that improved analytical technologies are continuously being developed. Our expertise spans all facets of Biopharmaceutical Testing and characterization.

Analytical Requirement	Methodology	Instrumentation
Monoclonal Antibodies	N-terminal sequencing (Edman chemistry), Mass-spectrometric sequencing	N-terminal sequencer, LC-MS, MALDI-MS
Amino acid composition	Amino acid analysis	RP-HPLC with fluorescence detector
Terminal amino acid sequence	N-terminal sequencing, Mass spectrometry	N-terminal sequencer, Mass spectrometer
Peptide map	Peptide mapping	LC-MS
Sulfhydryl groups and disulfide bridges	Non-reduced peptide mapping	LC-MS
Carbohydrate structure	Monosaccharide and oligosaccharide analysis, Linkage and site analysis	GC-MS, LC-MS, MALDI-MS
Molecular weight or size	Intact molecular weight analysis	LC-MS, MALDI-MS
Isoform pattern	IsoElectric Focusing (IEF)	Imaged Capillary IEF (icIEF)
Extinction coefficient	Optical density measurement	UV spectrophotometer, RP-HPLC
Electrophoretic analysis	Charge and size-based electrophoretic analysis	icIEF, CE-SDS

Veeda Biopharma scientists will accelerate the development of your product by providing the most efficient and
effective characterization strategies

State-of-the-Art Veeda Biopharma Analytical Technologies

Host Cell Proteins (HCPs) are residual proteins derived from the production cell line. While purification processes aim to eliminate them, trace amounts may still persist in the final product. Continuous monitoring of these HCPs is essential throughout the manufacturing workflow and in the final formulation to ensure product safety and quality.
To support this, we offer Host Cell Protein Mass Spectrometry (HCP-MS)—a proteomics-based approach that enables the identification and quantification of individual HCPs without the need for specialized antibody reagents. When combined with a commercial ELISA kit, LC-MS significantly enhances the detection coverage of the total HCP population in any sample, allowing for more comprehensive monitoring.
Importantly, we have developed proprietary platform methods in-house that are ultra-sensitive, capable of detecting HCPs at sub-ppm levels. These advanced techniques provide high-resolution insights into the HCP profile, ensuring robust characterization and control throughout your process and in your final product.
To further strengthen HCP coverage, we employ DIBE (2D-DIGE–based coverage analysis) to validate anti-HCP antibody performance. This technique offers:

Sensitive detection of spots

Highly acceptable data quality

Analytical ease through simplified assay design

High resolution

Powerful applicability across multiple workflows

We have our in-house developed multi-attribute methods, which can confirm the glycan heterogeneity, oxidation, deamidation, isomerization, lysine variant,and sequence variants in a single platform method for any biologics.

Immunogenicity Risk in Biotherapeutics:
- Biotherapeutics can trigger unwanted immune responses.
- This can reduce drug efficacy and cause serious adverse events, compromising patient safety.
Regulatory Emphasis:
- Agencies like the FDA and EMA require structured immunogenicity risk assessments throughout drug development.
Importance of Early Assessment:
- Addressing immunogenicity early helps avoid costly failures in later stages of development.
- Early intervention ensures better therapeutic success and patient outcomes.
Role of MHC-Associated Peptide Proteomics (MAPPs):
- MAPPs can be integrated early in the development process.
- It helps identify potential immunogenic epitopes.
- This reduces risk, optimizes drug efficacy, and improves clinical outcomes.

MAPPs results correlate with observed clinical immunogenicity, highlighting its predictive power in biotherapeutic development. Veeda’s MAPPs platform detects even low-abundance MHC-presented peptides, minimizing the risk of missing critical T cell epitopes. The assay consistently identifies a broader range of self and non-self immunopeptides than typically reported, ensuring a thorough immunogenicity profile. Moreover, it is also designed to capture the full repertoire of MHC class I (HLA-A/B/C) and class II (HLA-DR/DP/DQ) peptides, including specific HLA allotypes, for deep immunopeptidomics analysis.

FDA Filing Readiness

Our methods ensure your analytical package is robust for the rigorous scrutiny of the Biologics License Application (BLA) process. We prioritize the determination of Critical Quality Attributes (CQAs) required by the FDA and support Pre-License (PLI) and Pre-Approval Inspections (PAI) readiness.

Demonstrating'highly Similar' Status

We combine structural and functional data to provide the comprehensive evidence required by the EMA for Marketing Authorisation Applications (MAA). All clinical-phase analysis is managed under GCLP-compliant systems and harmonized quality standards for seamless EU acceptance.

Cost - Competitive & CDSCO Aligned

We leverage scalable operations to offer cost-competitive analytical solutions while maintaining global quality standards. Our reports are aligned with the CDSCO Guidelines for Similar Biologics , providing local expertise for submissions via the SUGAM portal.