A Broad Range of CMO/CDMO Services
-
Mammalian CLD
We have successfully completed over 40 Cell Line Development Mammalian projects -
Microbial CLD
KBI's Microbial CLD has the advantages of development speed, low cost & scalability
-
Publications & Presentations
Presentation | A Manufacturer’s Perspective on Innovations in Biomanufacturing
Learn More -
Publications & Presentations
Publication | Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing
Learn More
Cell Line Development
KBI has been applying established mammalian and microbial recombinant protein expression systems to provide rapid cell line generation services using:
- CHO-K1, CHO-S, CHO-DG44,
HEK293 and DXB11 - E. coli expression systems:
Insoluble (inclusion body)
Periplasmic
Both transient expression and stable pool generation approaches are available to support proof-of-concept (POC) material generation for preclinical programs designed to meet the client’s timeline and budgetary objectives.
Our Cell Line Development services include:
The cell line development activities are performed as stand-alone services or are fully integrated into larger scope process development programs. Selected cell lines are used for the generation of KBI internal research cell banks (RCBs). For full scope process development and cGMP manufacturing programs, the master cell bank (MCB) generation is outsourced to established third-party vendors. KBI conducts the quality audit of a vendor, transfers distribution vials of the selected RCB to the third party facility, manages and provides quality oversight of the pre-bank testing, the MCB production, testing and release under cGMP.
Additionally, KBI offers reporter cell line generation for cell-based assay development programs. These programs range from pre-clinical method transfer or development to cGMP qualification and validation in support of clinical and commercial Drug Substance and Drug Product release and stability testing.
A Broad Range of CMO/CDMO Services
-
Cell Culture
The cell culture team at KBI has developed robust, reproducible, & scalable processes -
Fermentation
Efficient, high quality & flexible fermentation development services that are scalable & robust -
Purification
KBI Biopharma has a strong reputation for developing purification processes for challenging biomolecules
-
Analytical
We employ a phase-specific lifecycle approach to analytics supporting process development & manufacturing -
Formulation
Our approach to preformulation and formulation development result in significant savings to our clients
-
Publications & Presentations
Presentation | High Throughput Bioreactor Mimetic in Early & Late Stage Process Development
Learn More -
Publications & Presentations
Publication | Viral clearance for biopharmaceutical downstream processes
Learn More
Process, Analytical & Formulation Development
The clinical and commercial success of biotherapeutics hinges on the development of robust, reproducible and scalable processes. KBI’s extensive process development and analytical development capabilities help our partners generate active product at an attractive cost while enabling rapid, reliable transfer to cGMP manufacturing.
Process Development Case Studies: Learn More
KBI process development activities cover the full development cycle, from supporting early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies. We take pride in our deep knowledge and experience in the science and practice of biopharmaceutical drug development. Our abiding customer focus and situational flexibility combined with a solid scientific base enable us to be the ideal partner for our clients’ biopharmaceutical process development needs.
Our services include:
KBI has extensive experience with both microbial (E.coli, yeast) and mammalian cell culture derived proteins. The KBI team has worked with protein production processes at all scales from laboratory, pilot and clinical scales to commercial scales up to 20,000L. We have conducted cutting-edge research into several technologies that are fundamental to process development and are adept at solving challenging issues on very short timelines.
KBI has well-developed platform processes for monoclonal antibodies and Fc fusion proteins and has helped several clients create their own platforms for novel therapeutic moieties.
Our high throughput tools for process and analytical development include miniaturized bioreactors through the Ambr® platform combined with high throughput chromatographic screening capabilities and a complementary set of analytical tools to enable rapid progress in process development. Through our experience, we can readily develop optimal experimental strategies that can lead to the rapid development of robust, reliable and scalable processes.
KBI’s full range of process development capabilities provide the tools to address client needs, whether they be in producing small quantities of proteins for research or in developing robust and scalable processes that can provide a solid competitive advantage.
A Broad Range of CMO/CDMO Services
-
Clinical Mammalian
Supplying First in Human & clinical resupply programs in our multi-product manufacturing facilities -
Clinical Microbial
Extensive experience in therapeutic protein & enzyme development, manufacturing & commercialization -
Clinical Release & Stability
We deliver accelerated & long-term stability studies, from protocol to documents for regulatory submission
-
Publications & Presentations
Publication | Innovation in biomanufacturing: the only way forward
Learn More -
Publications & Presentations
Presentation | A Manufacturer’s Perspective on Innovations in Biomanufacturing
Learn More
Clinical Manufacturing
KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for preclinical and clinical supply.
KBI’s experienced team produces high quality therapeutics and vaccines through processes developed in-house or through processes transferred in from our clients.
Our state of the art manufacturing facilities meet global regulatory requirements and employ the latest disposable production technologies, allowing for maximum flexibility and short turn-around times.
Our clinical manufacturing services include:
Our cell culture and microbial manufacturing facilities are fully separated including independent utility systems serving only their assigned production areas. Multiple HVAC zones, unidirectional flow of personnel and materials and strict environmental monitoring schema ensure the highest environmental quality for your clinical manufacturing process.
A Broad Range of CMO/CDMO Services
-
Commercial Mammalian
24x7 Commercial Manufacturing campaign operations scheduled for completion in Q4, 2017 -
Commercial Microbial
The KBI Colorado site is our center of excellence for microbial process development & cGMP manufacturing -
Commercial Release & Stability
We provide a complete range of conditions and methods to assure an accurate profile of your product
-
Publications & Presentations
Publication | Innovation in biomanufacturing: the only way forward
Learn More -
Publications & Presentations
Presentation | A Manufacturer’s Perspective on Innovations in Biomanufacturing
Learn More
Commercial Manufacturing
KBI Biopharma offers a broad range of cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Our capabilities include reliable manufacturing for commercial supply.
KBI’s experienced team produces high quality therapeutics and vaccines through processes developed in-house or through processes transferred in from our clients.
Our state of the art manufacturing facilities meet global regulatory requirements and employ the latest disposable production technologies, allowing for maximum flexibility and short turn-around times.
Our commercial manufacturing services include:
Our cell culture and microbial manufacturing facilities are fully separated including independent utility systems serving only their assigned production areas. Multiple HVAC zones, unidirectional flow of personnel and materials and strict environmental monitoring schema ensure the highest environmental quality for your commercial manufacturing process.
A Broad Range of CMO/CDMO Services
-
Cell Therapy Process Development
KBI can translate basic operating procedures into scalable manufacturing processes, accelerating clinical development programs -
Cell Therapy Analytical Development
We provide analytical development services for Product Identification, Quality, Purity, Activity, Potency Stability and Safety -
Cell Therapy GMP Manufacturing
KBI offers 3 independent culture suites, unidirectional flow of personnel and materials, and environmental monitoring
-
Clinical Cell Therapy Support
KBI can provide patient sample collection and product delivery with validated shippers as well as regulatory support -
Clinical Trial Therapeutic Monitoring
Our therapeutic monitoring programs are custom tailored to the product & clinical indication leveraging multiple methods
Cell Therapy
Cellular therapies are truly changing the course of health care for some of our most challenging disease indications, and the biopharmaceutical industry needs contract development and manufacturing solutions to accelerate delivery of these innovative products to patients.
KBI’s Cell Therapy team, located in The Woodlands, TX, has been managing a fully functional manufacturing facility supporting cell therapies and have been developing therapies under IND since 2001. Our team has substantial expertise and knowledge in the manufacturing, process development and regulatory aspects of cellular therapies as well as maintain strong relationships with the US FDA and Health Canada.
KBI provides the following Cell Therapy services:
Ph I/II GMP manufacturing capabilities in ISO 5 BSC and ISO 7 clean rooms
Our GMP cell culture facility offers three independent culture suites, unidirectional flow of personnel and materials, and environmental monitoring to support quality manufacturing processes.
Process Development
KBI’s Process Development capabilities allow us to translate basic science assays into robust, reproducible, scalable manufacturing processes to accelerate a client’s clinical development program.
Parallel processing of cell therapy products
Through stringent control of processes, materials and equipment, we can process numerous products for a single client’s project in parallel, thereby reducing cost and time required for a project.
Clinical Logistics
Centralized receipt, manufacture, and supply of patient materials to facilities across North America.
Therapeutic Products
The ability to develop and manufacture cellular therapeutics for clinical indications including autoimmunity, immunoncology, and regenerative medicine
Autologous & Allogeneic Cell Therapy
- Conventional T cells
- Regulatory T cells
- Dendritic cells
- Macrophages
- B cells
- NK cells
- Stem cells
- Tumor cells
- Cell Lines
- Genetically engineered cells (CAR-T, TCR)
- Antigen-specific T cells
Learn more about we can help you with:
- Process Development
- Analytical Development
- GMP Manufacturing
- Clinical Cell Therapy Support
- Clinical Trial Therapeutic Monitoring
A Broad Range of CMO/CDMO Services
-
Particle Characterization Core Facility
KBI offers state-of-the-art analysis for subvisible particles ranging in size from nanometer to micron -
Modeling & Simulation
We provide increased process understanding while minimizing investment in costly experimentation -
Biophysical Characterization
Our expertise drives accelerated decision-making at every stage of process development & manufacturing
-
CMC Submissions
Our technical team has extensive experience in generating submission-ready data & reports -
Mass Spectrometry Core Facility
Our state-of-the-art facility delivers unparalleled structural characterization services to our clients -
Process Characterization / Process Validation
Our stand-alone package supports late-stage process development and commercialization
-
Publications & Presentations
Presentation | Getting Biopharmaceutical Production Processes Right the First Time
-
Publications & Presentations
Presentation | Quality by Design at a Biopharma CMO
Characterization & Consulting
We offer a comprehensive range of analytical, biophysical characterization, mass spectrometry, and modeling and simulation capabilities. KBI’s scientists expertly apply these technologies and and methodologies to interpret the data to deliver the right information needed to support your product through all stages of development as stand-alone consulting services.
KBI has substantial experience in the design and execution of analytical comparability studies. We have executed such studies in support of reference material characterization, manufacturing site changes, and biosimilar-to-innovator comparability, just to name a few. KBI can develop the protocol, perform the analyses, analyze the data, and provide a submission-ready comparability report with all requisite figures and tables.
Our services include:
- Particle Characterization Core Facility
- Modeling & Simulation
- Biophysical Characterization
- CMC Submissions
- Mass Spectrometry Core Facility
- Process Characterization/Process Validation
Whether you are seeking developability data to support proof-of-concept, initial characterization to support IND filing, or comprehensive forced degradation and impurity characterization to support BLA licensure, KBI offers the experience and instrumentation needed to enhance your understanding of your molecule and accelerate development.