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KBI Biopharma - CDMO/CMO

KBI Biopharma, Inc., a JSR Life Sciences company, together with its affiliates, is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. As a global leader in mammalian cell line development, with best-in-class modular technology and highly specialized solutions, KBI enables the life sciences industry to rapidly discover, develop, and commercialize innovative medicines and vaccines. With each of its 500+ customer partners, KBI works closely to personalize and rapidly accelerate drug development programs. Global partners are utilizing KBI’s technologies to advance more than 170 drug candidates in preclinical and clinical development and the manufacture of 11 commercial products. Built upon a foundation of world-class analytics capabilities...

Address: 4117 Emperor Blvd, NC 27703, Durham
United States
United States Local time:

Leading in biopharmaceutical development and biologic API production.

Comprehensive services from cell line development to commercial manufacturing.

Strong track record in delivering complex and high-quality biologics.

Our services:

Drug Substance
Drug Product

Production scale:

large
small
medium

Response time:

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Established in:
1996

Services

Drug Substance (CDMO/CRO)

Biologics are complex medicines derived from living cells, used in treating diseases such as cancer, autoimmune disorders, and more. CDMOs specializing in biologics offer capabilities in cell line development, upstream/downstream processing, and sterile fill-finish.
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Drug Product (CMO)

Biologic products include complex therapies such as monoclonal antibodies and vaccines. CDMOs offer cell culture, protein expression, purification, and GMP manufacturing for commercial use.
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Contact KBI Biopharma for Contract Services Expertise

Connect with KBI Biopharma, a leading pharmaceutical company from United States. They offer specialized Drug Substance (CDMO/CRO), Drug Product (CMO). Contact KBI Biopharma for free and discover if they are the perfect partner for your pharmaceutical needs.

Drug Substance (CDMO/CRO)

Drug Substance CDMOs and CROs provide essential services in the development and manufacturing of active pharmaceutical ingredients (APIs). These organizations specialize in early-stage research, process development, and GMP-compliant manufacturing of drug substances for clinical and commercial use.


Pharmaoffer's Drug Substance CDMO/CRO category includes partners with expertise in small molecules, biologics, peptides, and complex chemistry, all operating under strict regulatory compliance. These providers help companies scale from lab to market efficiently and cost-effectively.


Key Functions of Drug Substance CDMOs/CROs:


  • API Research and Development: Providing early-stage discovery support, custom synthesis, and process optimization to streamline the development of drug substances.

  • Process Scale-Up and Tech Transfer: Transitioning from bench-scale to pilot and commercial scale production with validated methods and reproducibility.

  • GMP Manufacturing: Delivering high-quality API batches in GMP-certified environments, adhering to FDA, EMA, and other international standards.

  • Analytical Services: Offering comprehensive analytical method development and validation to ensure consistent quality and regulatory compliance.

  • Flexible and Specialized Capabilities: From small molecule synthesis to biologic and peptide manufacturing, these partners provide specialized services tailored to product-specific needs.


Explore Leading API CDMOs and CROs

Pharmaoffer connects you with trusted CDMOs and CROs for drug substance development. Our platform enables seamless access to specialized service providers equipped to support your API lifecycle from discovery to commercialization.

Drug Product (CMO)

Drug Product CMOs focus on the manufacturing and packaging of finished pharmaceutical dosage forms. These contract partners provide scalable production solutions that meet global regulatory and quality standards, supporting pharma companies throughout the drug product lifecycle.


Pharmaoffer’s Drug Product CMO category includes providers capable of manufacturing oral solids, injectables, topical formulations, and more—whether for clinical trials or commercial distribution.


Key Functions of Drug Product CMOs:


  • Formulation Development: Supporting the transition from drug substance to drug product through formulation optimization and compatibility testing.

  • Clinical and Commercial Manufacturing: Offering pilot-scale to high-volume manufacturing for various dosage forms under GMP conditions.

  • Packaging and Serialization: Providing primary and secondary packaging with serialization and tamper-proof labeling to meet compliance requirements.

  • Regulatory Support: Ensuring that all production meets FDA, EMA, and ICH standards for drug product quality, safety, and traceability.

  • Flexible Production Lines: Handling diverse dosage forms including tablets, softgels, liquids, and sterile injectables.


Partner with Proven Drug Product CMOs

Through Pharmaoffer, discover CMOs that excel in drug product manufacturing. Whether you need small-scale batches or full commercial output, our platform connects you with the right partners for compliant, cost-effective solutions.

KBI Biopharma


KBI Biopharma, Inc., a JSR Life Sciences company, together with its affiliates, is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. As a global leader in mammalian cell line development, with best-in-class modular technology and highly specialized solutions, KBI enables the life sciences industry to rapidly discover, develop, and commercialize innovative medicines and vaccines. With each of its 500+ customer partners, KBI works closely to personalize and rapidly accelerate drug development programs. Global partners are utilizing KBI’s technologies to advance more than 170 drug candidates in preclinical and clinical development and the manufacture of 11 commercial products. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs. Recognized for quality manufacturing, KBI helps partners advance drug candidates to the market. KBI serves its global customers with six locations in Europe and the USA. More information is available at www.kbibiopharma.com.

Specialties

CLD, Process Development, Manufacturing, Mass Spectrometry, Fermentation, Cell Culture, Analytical, Purification, Release & Stability, Formulation, Modeling & Simulation, Particle Characterization, Biophysical Characterization, CHO HCP, ultracentrifugation, AUC, and cell therapy logisitcs