ライフサイエンス企業情報プラットフォーム

JSR株式会社

JSRグループのライフサイエンス事業は「JSR Life Sciences」として、抗体医薬製造用材料(バイオプロセス用材料)、診断・研究試薬材料、抗体医薬開発・製造受託サービスを提供しています。

会社カテゴリー:原薬・添加剤・中間体、製造受託機関(CMO)、分析、試験受託サービス、医薬品製造関連資材、研究関連資材

主サービス提供地域:日本、アメリカ合衆国、中華人民共和国、大韓民国、台湾、ヨーロッパ(イギリス以外)、イギリス、インド

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ニュースリリース

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製品・サービス

2022/02/16

Characterization & Consulting
バイオ医薬品の分析サービス

原薬、開発、分析、製造

KBI offers a comprehensive range of analytical, biophysical characterization, mass spectrometry, and modeling and simulation capabilities. We apply these technologies to interpret your data and deliver information needed to support your product.
 

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 methodologies to interpret the data to deliver the correct 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, 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 Characterization and Consulting Services Include:

Whether you seek developability data to support proof-of-concept, initial characterization for IND filing, or comprehensive forced degradation and impurity characterization to support BLA licensure, KBI offers the experience and instrumentation needed to enhance the understanding of your molecule and accelerate development.

詳細はこちら

2022/02/16

Cell Therapy
細胞治療用受託開発製造サービス

原薬、分析、開発、製造

Cellular therapies are genuinely changing the course of health care for some of our most challenging disease indications. KBI’s cell therapy team manages a fully functional manufacturing facility supporting cell therapies and developing therapies under IND. 

Cell Therapy

Cellular therapies are genuinely changing the course of health care for some of our most challenging disease indications. The biopharmaceutical industry needs contract development and manufacturing solutions to accelerate the delivery of these innovative products to patients.

KBI's Cell Therapy team, located in The Woodlands, TX, has managed a fully functional manufacturing facility supporting cell therapies and developing therapies under IND since 2001. Our team has substantial expertise and knowledge in cellular therapies' manufacturing, process development, and regulatory aspects, including maintaining solid relationships with the US FDA and Health Canada.

Our Cell and Gene Therapy Manufacturing Services Include:

Ph I/II GMP manufacturing capabilities in ISO 5 BSC and ISO 7 cleanrooms

Our GMP cell culture facility offers three independent culture suites, a unidirectional flow of personnel and materials, and environmental monitoring to support quality manufacturing processes.

Cell Therapy Process Development

KBI's Process Development capabilities allow us to translate primary science assays into robust, reproducible, scalable manufacturing processes to accelerate a client's clinical development program.

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:

詳細はこちら

2022/02/16

Cell Line Development
遺伝子組み換えタンパク医薬の産生細胞の構築
(CHO細胞および大腸菌)

原薬、分析、開発、製造

 KBI's cell line development activities are performed as stand-alone services or are fully integrated into larger scope process development programs to support cGMP manufacturing at KBI facilities.
 

Mammalian Cell Line Development 
KBI can apply established mammalian recombinant protein expression systems to provide rapid cell line generation services using:

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.



The master cell bank (MCB) generation is outsourced to established third-party vendors for full-scale process development and cGMP manufacturing programs. KBI conducts a vendor quality audit, 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. Learn more about our manufacturing services.

Microbial Cell Line Development

KBI applies proven, well-characterized, off-the-shelf, or engineered microbial recombinant protein expression systems to provide state-of-the-art cell line development. KBI leverages high throughput fermentation and analytical screening tools to rapidly identify the most promising expression strategy, including tailored approaches based on protein chemistry and structural assessment. Typical expression systems will drive soluble or insoluble protein accumulation in the cytosol, and periplasmic accumulation can be employed in specialized cases depending on the protein of interest. In instances where expression favors insoluble protein accumulation in inclusion bodies (IBs), KBI develops high-yielding recovery processes with the analytical characterization of conversion to an active product by solubilization and refolding procedures.

詳細はこちら

2022/02/16

Process, Analytical, & Formulation Development
製造プロセス・分析試験法・製剤処方の開発

原薬、分析、製造、開発

KBI’s biopharmaceutical process development activities cover the full development cycle. From supporting early-stage discovery efforts and small-scale protein production, to fully-integrated, comprehensive process development programs leading to cGMP manufacturing.
 

Biopharmaceutical process development and manufacturing

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 cGMP manufacturing.

KBI's process development activities cover the full development cycle. We support 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 process development 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 2,000L. We have conducted cutting-edge research into several technologies 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 complimentary 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 biopharma process development capabilities provides the tools to address client needs, whether in producing small quantities of proteins for research or in developing robust and scalable processes that can provide a solid competitive advantage.

詳細はこちら

2022/02/14

CLONALITY ASSURANCE クロナリティの評価

開発、分析、製造

Establishing monoclonality of research cell banks (RCB) and manufacturing cell banks (MCB) is critical for successful and cost-effective biologic manufacturing campaigns and regulatory filings.

研究用細胞株(RCB)と製造用細胞株(MCB)のクロナリティ評価サービス。規制当局との円滑な交渉、また製造に伴うリスクの低減をサポートします。


Selexis is able to establish monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, establishes clonality...

Utilizing whole genome sequencing (WGS) and proprietary bioinformatics tools, Selexis is able to establish monoclonality of its RCB through an unbiased approach that identifies and validates integration sites, establishes clonality using integration sites as markers and provide transgene sequence, copy number and integrity. Additionally, Selexis has established a method for establishing clonality, based on a FISH-DNA platform, by detecting the specific location of the integrated recombinant transgene at the chromosomal level. In the case that two or more FISH patterns are found in the MCB, either the cell line is nonclonal in origin or chromosomal rearrangement has occurred during propagation. This method allows for analysis of single cells to assess the homogeneity within the parental population.

Three Possible Solutions for Accurate Determination of Clonality of Cell Lines:

詳細はこちら

2022/02/14

CELL LINE DEVELOPMENT 細胞株の構築(CHO細胞)

開発、分析、製造

Selexis is helping global partners advance complex biologics into the clinic faster, and ultimately help drive more life-saving biologic medicines to millions of waiting patients.

Selexisは動物細胞株構築に先進的に取り組むスイスのライフサイエンス企業です。多くの組み換えタンパク質を安定的かつ効率的に培養できる細胞株を、短期間で構築いたします。
 

Cell Line Development – stable, high-yield, and clonal mammalian cell lines

Selexis offers comprehensive and rapid solutions for the development of stable, high-yield, and clonal mammalian cell lines that are used in recombinant protein drug manufacturing.

By combining SUREtechnology Platform™ and world-class expertise, Selexis SURE Cell Line Development™ Services significantly reduce the time, effort, and costs that are associated with the development of high-performance mammalian cell lines for therapeutic protein production (e.g., development of monoclonal antibodies, bi-specific monoclonal antibodies, growth factors, Fc Fusions and enzymes).

The development of high-yield production cell lines starts with the cloning of the gene of interest into SUREtech Vectors™ that bear Selexis SGE® (Selexis Genetic Elements). These optimally designed DNA expression vectors are then transfected into the fully documented Selexis SURE CHO-M Cell Line™ using the SUREfection™ procedure.

By applying single cell cloning from the selected stable pools, Selexis identifies high-expressing clonal cell lines that are then evaluated for their growth characteristics using fed-batch cultures.

Innovation Every Step of the Way

詳細はこちら

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