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Analytical CDMO Services 

Innovators don't gamble on their data.
They come to KBI.

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Trusted Analytical and Formulation Expertise for CMC Programs

Standalone Services or Integrated Development
Through Drug Product Manufacturing


Our T.I.M.E. framework—Transparency, Integration, Methods, and Experience—ensures clear communication, seamless collaboration, and proven, validated approaches that de-risk and accelerate your path to market. 

Transparency
that empowers

 

Clear communication and processes with straightforward pricing and timelines

Integration
that simplifies

 

Seamless collaborative approach and regulatory-ready solutions 

Methods
that de-risk

 

Proven, validated approaches with regulatory compliance from the start

Expertise
that accelerates

 

30+ years supporting diverse biologics with deep regulatory knowledge and rapid problem-solving experience

30
+

Years of Experience

4300
+

Analytical Projects

1400

Client Partners

Standalone Services

Delivering the analytical expertise you need to de-risk and accelerate biologics programs

In the fast-paced world of drug development, flexibility is just as critical as scientific rigor. KBI Biopharma’s Standalone Services are designed for customers who require specialized expertise without the immediate need for a fully integrated end-to-end program. Whether you are navigating a specific regulatory hurdle, require high-end characterization, or need a robust cell line to start your journey, KBI provides the precision of a top-tier CDMO in a modular, accessible format. 

Standalone Analytics

Rapid Analytics 

Ad-hoc analytical testing including mass spectrometry, particle forensics, analytical ultracentrifugation, biophysical characterization testing. 

Automated Plate-Based Assays 

Ad-hoc analytical testing for plate-based assays using our state-of-the-art high-throughput and automated platforms. 

Cell Based and Binding Assays 

Development and testing services to evaluate product potency based on biological mechanism of action. Robust method support from product characterization through commercialization. 

High Throughput SPR Binding

Integration of high-throughput Surface Plasmon Resonance (SPR) and Biolayer Interferometry (BLI) into our broader analytical development and characterization platforms to support biotherapeutics from early-stage discovery through commercialization.

Mass Spectrometry 

Mass Spectrometry based solutions, from development and validation of product quality methods for QC to investigation and structural characterization of novel product impurities. 

   

Development, Formulation, & Stability

We provide end-to-end support for your biotherapeutic journey, ensuring every molecule is optimized for performance, safety, and clinical success.

Method Establishment

We offer comprehensive analytical development services at every phase of the project cycle. Our team focuses on building a foundation of precision and reliability for your unique molecular needs.

Formulation Development

Maximize therapeutic performance and clinical outcomes by developing robust, optimized formulations. We bridge the gap between discovery and delivery through advanced scientific modeling.

Release and Stability

Ensure the quality, safety, and efficacy of your biotherapeutics over time. Our programs reliably evaluate products at release and during long-term storage to meet stringent regulatory standards.

Compatibility and In-Use Stability

Minimize patient risk and improve clinical outcomes by evaluating critical quality attributes (CQAs). We use selected drug product administration clinical protocols to ensure your product performs exactly as intended in a real-world setting.

Characterization and Comparability

We provide deep analytical insights and strategic guidance to ensure your biopharmaceutical products remain consistent, safe, and optimized through every stage of development.

Product and Process Characterization

Access a comprehensive range of biophysical, biochemical, and biological characterization services. Our technical suite includes high-resolution mass spectrometry, cell-based assays, particle forensics, and advanced biophysical core technologies.

Comparability

Maintain product integrity across manufacturing changes. Our analytical comparability studies rigorously assess Critical Quality Attributes (CQAs) from pre- and post-change lots, providing a reliable comparison of product quality, safety, and efficacy.

Similarity

Achieve biosimilar licensure with confidence. We perform detailed similarity studies that assess physical, chemical, and biological properties to demonstrate bioequivalence to a reference biologic and support claims of equivalent safety.

Consulting

Partner with our industry experts for strategic biopharmaceutical guidance. We work closely with your team to optimize product development and manufacturing processes, ensuring a streamlined path to market.

Molecule Development

We accelerate your path to clinic by combining cutting-edge digital tools with industry-leading expression platforms to build a foundation for high-quality biotherapeutics.

Digital Molecule Assessment

Leverage advanced modeling and simulation tools to drive your development strategy. Our digitally driven services accelerate R&D timelines and optimize molecular outcomes before entering the lab.

Developability

Ensure your molecule is built to succeed at every stage of the pipeline. We conduct comprehensive assessments to evaluate critical factors, including molecule stability, manufacturability, and long-term efficacy.

Microbial Cell Line Development

Achieve high-titer microbial expression without compromising on safety or quality. Our platforms are designed for scalability, ensuring consistent protein production across various scales of manufacturing.

Mammalian Cell Line Development

Access robust, CHO-based mammalian expression systems tailored to your specific molecule. We focus on high productivity and versatile performance to meet the unique needs of complex biotherapeutic programs.

How We Work With Clients

Flexible Engagement Models for Analytical & Development Services

Every client program is unique. Some require rapid routine testing, while others need dedicated scientific teams supporting complex development programs. At KBI, we offer four flexible engagement models designed to match the needs of each stage of development.

All programs are supported by:

  • A dedicated Program Manager (PM)
  • A scientific Technical Lead
  • Qualified laboratory teams with expertise across analytical and formulation sciences

Your PM and Technical Lead serve as your primary points of contact, ensuring clear communication, scientific alignment, and efficient program execution.

Rapid Access Testing


Best for: Routine testing and established methods
More info

Hourly Services


Best For: Flexible
exploratory work
More info

Fixed Fee-for-Service


Best for: Defined
scope projects
More info

FTE Programs


Best for: Long-term
strategic development
More info

KBI Biopharma Standalone Services 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 Standalone Services 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

Analytics Portal Login 

ANALYTICS PORTAL

Integrated Analytics

Scalable Processes. Proven Success.


In the complex journey of therapeutic development, fragmentation is the enemy of speed. KBI Biopharma’s Integrated Services offer a seamless, end-to-end partnership designed to collapse timelines and eliminate the risks inherent in hand-offs between siloed providers. By unifying cell line development, process development, analytical characterization, and GMP manufacturing under one roof, we provide a cohesive strategy that accelerates your path to the clinic and beyond. 

  • Risk Mitigation: Cross-functional teams ensure your molecule is designed for scale from day one.
  • Accelerated Timelines: Parallel-path workflows can deliver clinical drug substance in as little as 9–12 months from DNA.
  • Unified Quality: A single QMS and project manager across all global sites (U.S. and Europe) simplifies your regulatory filings.
  • End-to-End Delivery: Seamless transition from process development to 2,000L GMP manufacturing.

 

Talk To An Expert

Share your contact details to connect with our team, and an expert will follow up to discuss how we can support your analytical and formulation needs. 

Flexible, Knowledgeable, and Proven


About KBI Biopharma

KBI Biopharma is a leading global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of our 1400+ customer partners, we work closely to personalize and accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, we deliver robust process development and clinical and commercial cGMP manufacturing services for mammalian and microbial. Recognized for quality manufacturing, we help clients advance drug candidates into the clinic and beyond.

Science Driven. Customer Focused.