Analytical Development
Product Description
KBI Biopharma Inc.
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US
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2015On CPHI since
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1000 - 4999Employees
Company types
Primary activities
Categories
Specifications
KBI Biopharma Inc.
-
US
-
2015On CPHI since
-
1000 - 4999Employees
Company types
Primary activities
More Products from KBI Biopharma Inc. (4)
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Product Cell Line Development
KBI offers a full suite of CLD across both mammalian and microbial expression systems. KBI can apply established mammalian recombinant protein expression systems to provide rapid and industry-leading cell line generation services using: CHO-M Selexis SUREtechnology, CHO-ZN, CHO-DG44, CHO-S, and CHO-K1 GS. ... -
Product Process Development
The clinical and commercial success of biotherapeutics hinges on developing robust, reproducible, and scalable processes. KBI's extensive process development and analytical development capabilities help our partners generate active products at an attractive cost while enabling rapid, reliable transfer to c... -
Product Formulation Development
KBI’s approach to formulation development is based on the strategic pairing of two complementary scientific disciplines:
• Establishing a comprehensive understanding of the thermal, physical, chemical, and conformational stability. • Employing statistical design-of-experiment (DOE) to evaluate main ef... -
Product Characterization
Scale-down process characterization studies performed using a qualified scale-down model are a critical part of licensure applications for biologics.
KBI has significant expertise in the design and execution of these studies to enable customers to define their process control strategy to take ...
KBI Biopharma Inc. resources (3)
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News CPHI Barcelona 2023: Tackling the Pharma Talent Precipice – Part 2
This year at CPHI Barcelona (24–26 October, 2023) we sat down with C-suite executives and HR professionals to discuss the looming talent crisis in the pharmaceutical industry. With hybrid working persisting post-pandemic and a growing skills gap, how can the pharmaceutical supply chain adjust to a changing labour force? -
Whitepaper Navigating a New Standard in Microbial Protein Expression
An ideal therapeutic protein “factory” creates a pure target product with high titers from the start, which can minimize development risk, timelines, and cost. E. coli has long been implemented as a therapeutic protein factory due to its simplicity, tractability, and wealth of information characterizing the microbe.
While common E. coli expression strains alter as many as five genes to improve one aspect of recombinant protein expression, KBI has created a platform E. coli with about 1,000 genes altered and roughly 1 Mbp of DNA removed. The result is a PURE, efficient platform expression strain—PUREcoli™.
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Video Rapid Timeline to Tox Starting with KBI Biopharma's SUREtechnology Platform™, Powered by Selexis
KBI Biopharma’s cell line development services, powered by Selexis®, have been at the forefront of innovation for the last two decades. We are introducing the latest version of proprietary SURE CHO-M technology, which uses a transposase-based semi-targeted integration method and provides high productivity and stable cell lines for therapeutic protein production, while exhibiting a doubling time of 15-17 hours. Using this transposase-based cell line, KBI Biopharma is now delivering tox material in as little as 6 months from transfection. The tox material will be generated with the top 6 clones. In addition, we are introducing an afucosylated host cell line for the generation of therapeutic proteins without any fucose residues. KBI Biopharma is also introducing a completely new targeted integration technology developed by our own next-generation sequencing software. This panel of new cell line offerings surpasses customer expectations and is set to establish new industry standards.
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