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Analytical

Developing lasting solutions to analytical challenges in biologics development

Global, Expert Analytics to Support Robust Data Requirements

Analytical and Process Development Support at Every Phase of the Project Cycle

 

The clinical and commercial success of biotherapeutics hinges on developing and supporting scalable and reproducible processes.

Analytics is a decision driver across every phase of a project cycle. At KBI, our deep expertise in analytics covers every stage of a project, from structure prediction and analysis to cell line development to commercial manufacturing - across non-cGMP and cGMP activities. Our extensive process and analytical development capabilities cover all stages, supporting early-stage development efforts through small-scale protein production to fully-integrated, comprehensive process optimization leading to cGMP manufacturing. From process and product characterization to scale-down validation studies and at every step along the way, we take pride in our deep knowledge and experience in the science and practice of biopharmaceutical drug development.

 

KBI's Phase-Specific Lifecycle Approach to Analytics

KBI employs a phase-specific interdisciplinary lifecycle approach to analytics. Combining cutting-edge technology, close collaboration, and keen insight, we create lasting solutions to analytical challenges that take your project from early-stage samples to highly-purified drug substances. 

KBI's full range of biopharma analytical and process development capabilities enables us to take on very early or very late programs with full confidence. With our depth of experience, we can readily develop relevant experimental strategies that lead to the rapid optimization of robust, reliable, and scalable processes. To do so, we rely on:

  • High throughput chromatographic screening capabilities
  • Complimentary analytical tools to enable rapid progress in process development

More Power to Develop, Manufacture, Repeat

The Right Data with the Right Insight

KBI Biopharma is a Trusted Global Leader in Protein Analytics

 

KBI offers a comprehensive range of analytical, biophysical characterization, cell-based assays, and mass spectrometry capabilities. Our scientists expertly apply these technologies and methodologies to interpret your data, delivering the correct information needed to support your product through all stages of development.

KBI Biopharma is a global partner for expert analytical, process, and formulation development. Our team of experts and world-class facilities around the globe ensure your success in developing the next biologics. Whether you are looking for developability data to support proof-of-concept, initial characterization for IND filing, or comprehensive forced degradation and impurity characterization to support BLA licensure, working with KBI Biopharma delivers a streamlined experience with the right experts and right instrumentation to enhance the understanding of your molecule. 

Process & Analytical Development for Cell Culture

Cell culture process development activities cover the full development cycle, from supporting early-stage discovery efforts through small-scale protein production all the way to fully-integrated, comprehensive process development programs that feed into cGMP manufacturing and validation studies. 

  • Industry-leading methodologies and techniques in high-throughput process development
  • 40+ annual programs ranging from First in Human (FIH) process development to late-stage process development, characterization, and validation
  • 15+ IND submissions supported annually

Our unwavering customer focus and situational versatility combined with a solid scientific base enable us to be the ideal partner for our clients.

 

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Fermentation Development

We have extensive experience with microbial cell culture-derived proteins. Our integrated fermentation, purification development, and analytical development teams work together for exceptional program outcomes.

  • Flexible fermentation development services
  • Reliable, robust, and scalable processes
  • Scale-down validation studies

Our efficient fermentation development services allow for the development and optimization of scalable, robust upstream processes.

 

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Process Development & Analytical Development for Purification

We have extensive experience developing purification processes for a wide range of biotherapeutics, including monoclonal antibodies, bispecifics, enzymes, Fc fusion proteins, PEGylated proteins, and more. By leveraging the experience gained from process development for more than 75 unique biomolecules, we have perfected our approach to developing processes with a unique toolbox to resolve unique protein purification challenges.

  • Industry-leading methodologies and techniques in high-throughput process development
  • 40+ annual programs ranging from First in Human (FIH) process development to late-stage process development, characterization, and validation
  • 15+ IND submissions supported annually

Our integrated process development and analytical development teams together bring a broad perspective that leads to robust product quality goal achievement for each program.

 

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Analytical Development 

Founded on analytics, and as its historical core strength, KBI employs a phase-specific transversal lifecycle approach to analytics. Our experience includes antibodies like IgG1, IgG4, IgM, FAb, ADC, and Fc fusion, enzymes, cytokines, growth factors, highly glycosylated proteins, protein vaccines, PEGylated proteins, conjugates, peptides, adeno-associated viruses (AAVs), oligonucleotides, and other unique proteins. 

  • 3000+ analytical projects
  • 100+ clients
  • 130+ distinct molecules

Our expertise includes HPLC, CE, ELISA, UV-Vis, mass spectrometry, light scattering, biophysical characterization (DSC, CD, FTIR, fluorescence), binding assays (ELISA, Biacore, ForteBio), glycan analyses, cell-based assays, and others.

 

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Formulation Development

Our approach to formulation development is based on the strategic pairing of two complementary scientific disciplines: first, establishing a comprehensive understanding of the protein's intrinsic properties and stability - through thermal, physical, chemical, and conformational stability characterization - and second, evaluating the interactions and main effects on protein stability, employing statistical design-of-experiment (DOE).  This approach enables KBI to develop robust formulations by eliminating uncontrolled stability variables, thus focusing solely on therapeutic performance and clinical outcomes. 

  • 130+ successful protein, peptide, and vaccine formulation development programs
  • Creation of robust formulations by eliminating uncontrolled stability variables
  • Stable liquid formulations for protein concentrations ranging from >1mg/mL to 200mg/mL.

 

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Characterization Services

Our comprehensive range of analytical, biophysical characterization, and mass spectrometry capabilities support your product through all stages of development, delivering the correct data and information needed at every step. 

  • Particle characterization for specialized, state-of-the-art analysis for subvisible particles ranging in size from nanometer to micron
  • Biophysical characterization to understand the thermal and conformational stability of proteins to support the development of optimized formulations
  • Mass spectrometry for protein and peptide characterization

Whether you seek developability data to support proof-of-concept, initial characterization for IND filing, or comprehensive forced degradation and impurity characterization to support BLA licensure, KBI offers the experience and instrumentation needed to enhance the understanding of your molecule and accelerate its development.

 

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Introducing the KBI Biopharma Analytics Portal

Streamlining Analytics Ordering and Sample Coordination

Self-Service Analytical Support at Every Phase of the Project Cycle

Our goal is to help you get innovative biologics to patients, faster. 

The KBI Biopharma Analytics Portal offers a one-stop-shop for quote requests, ordering, sample submission and shipment tracking, and a single visualization of studies. This fast and easy self-service process streamlines analytics ordering and sample coordination. 

  • Customer-centric quote management
  • Sample submission and real-time tracking
  • Unified visualization of studies, reports, and results
Request a Quote Today

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Explore Recent Resources

Expertise in Analytics

For Comprehensive Biotherapeutic Development, Manufacturing, and Downstream Processing

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Revolutionizing Particle Characterization in Biologics: A Focus on Image Analysis and Machine Learning

Dive deep into the world of biologics and discover the transformative power of image analysis and machine learning in particle characterization. Learn about the latest advancements in micro-flow imaging (MFI) technologies, the role of machine learning in refining data analysis, and how these innovations contribute to ensuring product safety and efficacy. Don't miss out on these invaluable insights! Fill out the form above to download your copy now and take a giant leap towards enhancing your biologics development and production processes.

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Using Advanced Mass Spectrometry for Characterization and Quantitation of APIs and Impurities in Complex Biotherapeutics

Increasing global demand for vaccines and complex biotherapeutics has led to a larger role for Contract Development and Manufacturing Organizations (CDMOs), who support the development of these products through all stages from product development to manufacturing. Advanced analytical capabilities, including mass spectrometry, are critical for the characterization of active pharmaceutical ingredients (APIs) and managing a diverse population of impurities. This allows for effective mitigation of safety risks and ensures product quality.  

Q&A

Mass Spectrometry for Complex Biotherapeutics: Q&A with KBI's Mass Spec Team

Mass spectrometry is critical for the characterization and management of active pharmaceutical ingredients (APIs) and impurities, an essential step for downstream processing and for ensuring product quality and safety. We recently sat down with Michael J. Nold, Ph.D., Senior Director of KBI’s Mass Spectrometry Core Facility in Durham, North Carolina, to discuss how advanced Mass Spectrometry plays a significant analytical role in the characterization and quantitation of APIs and impurities in complex biotherapeutics. 

Ready to Learn More? Get in Touch with our Team.

 

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