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Spotlight on Product Characterization

Bioinsights sponsored inteview on analytical tools, assay development and characterization.
Authors: Behnam Ahmadian
Publish Date: 01-Dec-2016

A Newly Defined and Xeno-Free Culture Medium Supports

PLOS one Peer reviewed paper on medium replacement in the generation of hiPSCs.
Publish Date: 01-Sep-2016

Detailed Characterization of Human Induced Pluripotent

Springerlink.com peer reviewed paper on the characterization of iPSCs manufacturing.
Publish Date: 01-Jun-2016

Managing particulates in cell therapy- Guidance for best practice

ISCT peer-reviewed paper on Managing particulates in cell therapy: Guidance for best practice.
Authors: Eytan Abraham
Publish Date: 01-May-2016

Manufacturing Human Induced-Pluripotent Stem Cells

BPI cell therapy Peer-reviewed case study on manufacturing hiPSCs for clinical application.
Publish Date: 01-Oct-2015

cGMP-Manufactured Human Induced Pluripotent Stem Cells

ISSCR peer-reviewed paper on cGMP manufacturing hiPSCs.
Publish Date: 01-Oct-2015

Critical elements in the development of cell therapy

ISCT peer-reviewed paper on Critical elements in the development of cell therapy potency assays for ischemic conditions.
Authors: Eytan Abraham
Publish Date: 01-Jan-2015

Scalable Passaging of Adherent Human Pluripotent Stem Cells

PLOS one Peer-reviewed paper on Scalable passaging of Adherent hIPSCs.
Authors: Thomas Fellner
Publish Date: 01-Jan-2014

Will your CMC strategy ensure your project aligns with its clinical path requirements and timeline?

Drug manufacturers can no longer apply a standardized approach to development and manufacturing, such as with mAbs. Instead, they must use a wide range of disciplines to define a product’s unique characteristics, the strategies for managing them, and the testing that needs to take place to ensure a drug consistently maintains its quality attributes from batch to batch. Regulatory authorities require this information to be outlined in the chemistry, manufacturing, and controls (CMC) section of the biologic drug application (BLA) and investigational new drug application, so they can have confidence a company’s drug production methods align with their requirements and expectations. Therefore, it is important you understand the challenges associated with creating a CMC strategy and the expertise and resources you need to successfully execute it.

Modulating IgG effector function by FC engineering and glycoengineering

Antibodies are the fastest growing group of biotherapeutics. In early 2020 more than 100 antibody-based molecules, including biosimilars, had been approved globally. Oncology and inflammatory disorders remain the major therapeutic areas for antibody-based molecules but there is a growing interest in using mAbs for treating infectious disease. During the last 10 years antibody engineering focussed on development of “fit-for-purpose” antibodies with modulated effector functions such as increased or muted antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), complement dependent cytotoxicity (CDC), and to increase half-life. This paper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies employing such approaches.
Authors: Andy Racher