KBI Biopharma - CDMO/CMO

KBI Biopharma specializes in biopharmaceutical development and manufacturing, offering a comprehensive suite of services spanning from early-stage discovery to commercial production. Known for their expertise in biologic and vaccine development, they provide integrated solutions including cell line development, analytical and formulation services, and clinical and commercial manufacturing. Their state-of-the-art facilities and robust quality systems...

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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:

CMO/CDMO

Production scale:

large

Response time:

Service categories

Biologics

Monoclonal Antibodies
Biosimilars
Gene and cell therapy products
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Established in:
1996

Our services


Biologics

Monoclonal Antibodies
Monoclonal antibodies represent a breakthrough in precision medicine, targeting specific disease markers. Their production, involving cell culture and purification techniques, is crucial for treating cancers, autoimmune disorders, and more, offering targeted, effective therapy.
Contact supplier

Replies slower than most

Biosimilars
Biosimilars are an emerging field in pharmaceuticals, offering cost-effective alternatives to biologics. Their development requires demonstrating similarity in efficacy and safety, involving complex analytical and clinical studies, crucial for expanding access to biologic therapies.
Contact supplier

Replies slower than most

Gene and cell therapy products
Gene and cell therapy products are at the forefront of personalized medicine, treating genetic and acquired diseases. Their production involves advanced techniques to modify genes or cells, requiring stringent safety and efficacy standards, revolutionizing treatment paradigms.
Contact supplier

Replies slower than most

Contact KBI Biopharma for Contract Services Expertise

Connect with KBI Biopharma, a leading pharmaceutical company from United States. They offer specialized CMO/CDMO - Contract (Development) Manufacturing Organizations, of which the services for CMO/CDMO include Monoclonal Antibodies, Biosimilars, Gene and cell therapy products. Contact KBI Biopharma for free and discover if they are the perfect partner for your pharmaceutical needs.

CMO/CDMO - Contract (Development) Manufacturing Organizations

CDMOs and CMOs are pivotal in the pharmaceutical and biotech industries, offering specialized services in drug development and manufacturing. They assist in scaling up production from laboratory to commercial quantities, while adhering to strict regulatory standards. These organizations play a crucial role in the efficient and cost-effective production of medical and pharmaceutical products, ensuring quality and compliance at every stage.


Pharmaoffer's category for Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) encompasses a wide range of specialized services crucial to the pharmaceutical and biotech sectors. These organizations, often referred to as pharmaceutical CDMOs or drug CMOs, are instrumental in advancing drug development and manufacturing processes.


Key Functions of CMOs/CDMOs:


  • Drug Development and Manufacturing Expertise: Offering comprehensive services in drug development, from initial research and development to full-scale manufacturing. This includes CDMO services and CMO manufacturing, ensuring a seamless transition from concept to market.

  • Scalability Solutions: Assisting in scaling production from laboratory to commercial scale, meeting the demands of various projects while maintaining quality and efficiency. This is where the expertise of a full-service CDMO becomes invaluable.

  • Regulatory Compliance and Quality Assurance: Ensuring adherence to strict regulatory standards such as FDA and EMA guidelines, and implementing rigorous quality control measures throughout the manufacturing process. This includes operating within GMP certified facilities to guarantee the highest standards of production.

  • Cost-Effective Production: Providing efficient and cost-effective solutions for the production of medical and pharmaceutical products, enabling companies to focus on innovation and marketing. CMO contract manufacturing plays a key role in this aspect.

  • End-to-End Service Provision: From concept to commercialization, CMOs/CDMOs offer a range of services including process optimization, formulation development, clinical trial material production, and commercial manufacturing. This comprehensive approach is often referred to as Contract Development Manufacturing.


Connect with Leading CMOs/CDMOs

Through Pharmaoffer, you can explore and connect with a comprehensive range of CMOs/CDMOs. Our platform offers access to organizations that play a vital role in the efficient, quality-assured, and compliant production of pharmaceutical and medical products, supporting the industry's growth and innovation. Whether you're looking for a CDMO partner, CDMO solutions, or contract manufacturers in pharma, Pharmaoffer is your gateway to the best in the industry.

Biologics

Biologics CMOs/CDMOs specialize in the manufacturing and development of biopharmaceutical products, which are typically derived from living organisms or biological sources such as proteins, antibodies, vaccines, and cell therapies. 


Biologics Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) encompass specialists in the production and development of biopharmaceuticals. These products, often derived from living organisms or biological sources, include proteins, antibodies, vaccines, and cell therapies. This sector includes biologics manufacturers, biopharma CDMOs, and companies dedicated to biologics development and biologic drug manufacturing.


Key Services Provided by Our Listed Biologics CMOs/CDMOs:


  • Advanced Biopharmaceutical Manufacturing: Utilization of cutting-edge biomanufacturing processes for the production of biologics, ensuring high purity, efficacy, and safety. This includes comprehensive biologics manufacturing and contract manufacturing biologics services.

  • Custom Antibody and Protein Development: Expertise in developing a range of biologic products, including monoclonal antibodies and therapeutic proteins, tailored to specific therapeutic needs. This is a key focus for many biologics companies and CDMO biotech firms.

  • Vaccine Production: Specialization in the manufacturing of vaccines using advanced technologies, contributing to global health and disease prevention efforts. This is a critical service offered by CMO biologics and biologics CDMO list members.

  • Cell Therapy Development: Capability to develop and manufacture innovative cell therapies, offering new treatment possibilities in regenerative medicine and oncology. This is a rapidly growing area within biologics development.

  • Regulatory Expertise: In-depth knowledge of the regulatory environment governing biologics, ensuring compliance with standards set by agencies like the FDA and EMA. This expertise is vital for all aspects of biopharmaceutical manufacturing.


Your Partner in Biologics Development and Manufacturing

Pharmaoffer provides a platform to connect with CMOs/CDMOs specializing in biologics. Our category ensures easy access to organizations that are equipped with the expertise and technology required for the complex development and manufacturing processes of biopharmaceutical products.

Monoclonal Antibodies

Monoclonal antibodies represent a breakthrough in precision medicine, targeting specific disease markers. Their production, involving cell culture and purification techniques, is crucial for treating cancers, autoimmune disorders, and more, offering targeted, effective therapy.


Pharmaoffer features a range of Contract Development and Manufacturing Organizations (CDMOs) with expertise in monoclonal antibodies production, a cornerstone of precision medicine. Monoclonal antibodies are designed to target specific disease markers, making them vital in treating a range of conditions including cancers and autoimmune disorders. This includes specialized services in Monoclonal Antibody Manufacturing and Monoclonal Antibody Production.


Key Services Provided by Our Listed CDMOs:


  • Advanced Cell Culture Techniques: Utilization of sophisticated cell culture methods to produce monoclonal antibodies with high specificity and efficacy. This is a fundamental aspect of antibody production services.

  • Precision Purification Processes: Implementation of state-of-the-art purification techniques to ensure the purity and potency of monoclonal antibodies.

  • Custom Antibody Development: Tailoring monoclonal antibody production to meet specific therapeutic targets and treatment objectives.

  • Quality Control and Regulatory Compliance: Adherence to strict quality control standards and regulatory requirements, ensuring the safety and effectiveness of the monoclonal antibodies.

  • Scalable Manufacturing Solutions: Capability to scale production from clinical trial quantities to large-scale commercial batches, meeting the demands of various healthcare needs.


Your Partner in Advanced Therapeutic Development

On Pharmaoffer, you can connect with CDMOs that specialize in the development and manufacturing of monoclonal antibodies. Our platform ensures access to cutting-edge technologies and expertise, essential for the production of targeted, effective therapies in the realm of biologics.

Biosimilars

Biosimilars are an emerging field in pharmaceuticals, offering cost-effective alternatives to biologics. Their development requires demonstrating similarity in efficacy and safety, involving complex analytical and clinical studies, crucial for expanding access to biologic therapies.


Pharmaoffer showcases a selection of Contract Development and Manufacturing Organizations (CDMOs) specializing in Biosimilars. This emerging field in pharmaceuticals provides cost-effective alternatives to original biologic therapies, including Biosimilar Development, Biosimilar Drug Manufacturing, and Biosimilar Production. Our platform connects pharmaceutical professionals with CDMOs experienced in the intricate process of biosimilar development.


Key Services Provided by Our Listed CDMOs:


  • Analytical Similarity Assessment: Comprehensive analytical studies to establish biosimilarity, focusing on molecular characterization, biological activity, and immunochemical properties. This is a key component of Biosimilar Development.

  • Clinical Development Expertise: Rigorous clinical trials to demonstrate equivalent efficacy and safety profiles compared to reference biologics. This expertise is vital in Biosimilar Drug Manufacturing.

  • Regulatory Strategy and Compliance: In-depth knowledge of regulatory pathways and standards, ensuring compliance with agencies such as the FDA and EMA for biosimilar approval.

  • Manufacturing Scale-Up: Capability to scale up biosimilar production, maintaining consistency and quality from lab-scale to commercial batches. This scalability is essential in Biosimilar Production.

  • Tailored Biosimilar Solutions: Custom development services for a wide range of biosimilar products, addressing various therapeutic areas.


Find Your Biosimilar Development Partner

On Pharmaoffer, pharmaceutical professionals can easily find and connect with CDMOs that have a proven track record in biosimilar development and manufacturing. Our platform ensures you have access to CDMOs that are committed to expanding access to biologic therapies through high-quality, cost-effective biosimilar products.

Gene and cell therapy products

Gene and cell therapy products are at the forefront of personalized medicine, treating genetic and acquired diseases. Their production involves advanced techniques to modify genes or cells, requiring stringent safety and efficacy standards, revolutionizing treatment paradigms.


At Pharmaoffer, we feature Contract Development and Manufacturing Organizations (CDMOs) that are pioneers in the field of gene and cell therapy products. These innovative therapies represent a significant advancement in personalized medicine, offering targeted treatments for genetic and acquired diseases. This includes expertise in Gene and Cell Therapy Drug Manufacturing and Gene and Cell Therapy Production.


Key Services Provided by Our Listed CDMOs:


  • Advanced Gene and Cell Modification: Utilization of state-of-the-art techniques for precise gene editing and cell modification to develop effective therapies. This is a key service of cell therapy CDMO and CGT CDMO providers.

  • Rigorous Safety and Efficacy Standards: Strict adherence to safety and efficacy standards, ensuring the highest level of patient safety and therapeutic effectiveness. This is crucial in cell therapy CMO services.

  • Scalable Manufacturing Solutions: Capability to scale from research-level batches to commercial-scale production, catering to the growing demand for gene and cell therapies.

  • Regulatory Expertise: In-depth understanding of the regulatory landscape governing gene and cell therapy products, ensuring compliance with FDA, EMA, and other regulatory bodies.

  • Comprehensive Development Services: From concept to commercialization, providing end-to-end development services including process development, clinical trial material production, and commercial manufacturing.


Your Partner in Revolutionary Treatments

Pharmaoffer connects you with CDMOs that specialize in gene and cell therapy production, essential for the new era of treatment paradigms. Our platform ensures you have access to partners with the expertise and infrastructure necessary to drive forward these groundbreaking therapies.

KBI Biopharma


KBI Biopharma specializes in biopharmaceutical development and manufacturing, offering a comprehensive suite of services spanning from early-stage discovery to commercial production. Known for their expertise in biologic and vaccine development, they provide integrated solutions including cell line development, analytical and formulation services, and clinical and commercial manufacturing. Their state-of-the-art facilities and robust quality systems ensure compliance with international regulatory standards.