Lambda Therapeutic Research provides comprehensive bioanalytical services for biotherapeutics and large molecules, supporting biologic and biosimilar programs across preclinical and clinical development. With extensive experience in large molecule bioanalysis, we recognize that each biotherapeutic has unique analytical requirements and demands a fit-for-purpose bioanalytical strategy.

Our bioanalytical teams work closely with sponsors to design and execute assays aligned with compound characteristics, study objectives, and regulatory expectations. Early in development, we support understanding of molecule behavior, potential biomarkers, and pharmacological response. During regulated clinical stages, we develop and validate assays in accordance with FDA, EMA, and OECD guidance to generate reliable data that support informed program decisions.

End-to-End Large Molecule Bioanalysis Support

Lambda offers integrated bioanalytical support across the full development lifecycle of biologics and biosimilars. These services support exploratory studies, First-in-Human programs, and late-phase clinical trials.

• Pharmacokinetic (PK) assessment
• Immunogenicity assessment, including ADA and neutralizing antibody assays
• Pharmacodynamic (PD) and biomarker evaluation
• Toxicokinetic (TK) measurement
• Bioanalytical method development
• Bioanalytical method validation

Expertise in Biologics and Biosimilars

Lambda’s bioanalytical teams have extensive experience supporting biologic and biosimilar programs across diverse modalities and study designs.

• PK assays for large molecules
• Anti-drug antibody (ADA) testing
• Neutralizing antibody (NAb) assays
• Pharmacodynamic and biomarker assays

This expertise supports comparative PK studies, immunogenicity evaluations, and biomarker-driven clinical assessments.

Large Molecule Modalities Supported

Lambda supports a wide range of biotherapeutic modalities, including:

• Monoclonal antibodies
• Peptides and proteins
• PEGylated proteins
• Antibody-drug conjugates
• Enzymes
• Gene therapy products

Analytical Platforms and Capabilities

Lambda employs multiple analytical platforms to support diverse large molecule modalities and assay requirements.

• Enzyme-linked immunosorbent assays (ELISA)
• Electro-chemiluminescent assays (ECLIA)
• LC-MS/MS for peptides and selected monoclonal antibodies
• Cell-based assays for neutralizing antibody evaluation
• Enzymatic assays for blood factors
• In vitro diagnostic assays for biomarker analysis

Core Bioanalytical Platforms & Instruments

• ELISA plate readers
• MSD readers
• LC-MS/MS systems
• Flow cytometers
• ICP-MS
• Automatic liquid handling system (Hamilton)
• COBAS e411
• Automated plate washers
• ELISpot readers

Immunogenicity Assessment Capabilities

Immunogenicity testing is a critical component of biologic and biosimilar development. Lambda provides validated and regulatory-aligned approaches for ADA and neutralizing antibody evaluation.

Anti-drug antibody (ADA) assays:

• Bridging ELISA and ECLIA with acid pretreatment
• Solid-phase extraction with acid dissociation (SPEAD)
• Precipitation and acid dissociation (PANDA)
• Acid capture elution (ACE) methods
• Magnetic bead-based immunoassay

Neutralizing antibody (NAb) assays:

• Cell-based bioassays – Cell growth, signalling, and secretion assays
• Competitive ligand-binding assays – ELISA and ECLIA
• Enzymatic inhibition assays – enzyme activity

The Lambda Advantage

Lambda’s bioanalytical operations are built on experienced scientific teams, regulatory-aligned processes, and established laboratory infrastructure ensuring precise results.

• GLP-certified bioanalytical laboratory since 2014
• BSL-1 and BSL-2 compliant facilities supported by robust quality management systems
• Completepackage of bioanalytical services aligned with FDA and EMA Guidelines
• Successful FDA, EMA, MHRA, and ANVISA inspections for biosimilar studies
• Expertise, Compliance, Customization & Speed

Experience in long-duration clinical programs:

• Assay and reagent lifecycle management across Phase I to Phase III
• Bridging method validations for changes in biological matrices, drug products, and critical reagents

Why Partner with Lambda

• Integrated bioanalytical, clinical, and data functions within one CRO
• Strong experience across biologics and biosimilars
• Regulatory-aligned assay development and validation
• Scalable infrastructure supporting early and late-phase programs
• Consistent delivery across long-duration clinical studies

To discuss assay feasibility or bioanalytical support for your biotherapeutic or large molecule program, contact: BD@lambda-cro.com

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About Lambda

Lambda & Novum delivers full-service CRO services to the innovator, biotech, and generic pharmaceutical industries worldwide. With a strong global presence in India, the USA, Canada, the UK, Spain and Poland, we bring specialized expertise to every project. Our focus on secure IT infrastructure and automation ensures timely project delivery and strict adherence to international regulatory standards. Lambda’s exemplary regulatory track record includes over 60 successful inspections and audits by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global regulatory bodies, in the past five years.

Lambda’s commitment to excellence has garnered significant recognition, including the ‘Best Indian CRO’ award from Frost & Sullivan (USA) and the ‘Great Indian Workplace’ title from UBS Transformance. Recent accolades include the ‘Regulatory Excellence’ Award at the CPhI Pharma Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.