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Related Concept Videos

Cell Lines01:16

Cell Lines

A cell line is a population of cells grown in vitro that can be subcultured over several generations. Normal cells cease to divide after a certain number of cell divisions, a process known as replicative senescence. This number, called the Hayflick limit, was conceptualized by Leonard Hayflick in 1961 when he observed that fetal cells grown in culture could only divide 40-60 times. This limit is due to the shortening of the telomeres during each round of cell division, preventing cell division...
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...

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Chimeric Antigen Receptor T Cell Manufacturing on an Automated Cell Processor
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Testing considerations for novel cell substrates: a regulatory perspective.

A S Khan1

  • 1Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, MD, USA.

PDA Journal of Pharmaceutical Science and Technology
|April 20, 2011
PubMed
Summary
This summary is machine-generated.

Novel cell substrates in biologics raise safety concerns regarding adventitious agents and oncogenicity. This paper reviews testing recommendations for these novel materials, focusing on tumorigenic and genetically engineered cells.

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Area of Science:

  • Biologics Manufacturing
  • Vaccine Development
  • Cellular Therapy

Background:

  • Novel cell substrates are increasingly used for biologics, including vaccines and therapeutic proteins.
  • Emerging infectious diseases and advanced therapies necessitate the use of innovative cell substrates.
  • Safety concerns include adventitious agents (viruses) and potential oncogenicity of cell substrates.

Purpose of the Study:

  • To discuss safety issues associated with novel cell substrates in biologics.
  • To focus on safety concerns related to tumorigenic and genetically engineered cells.
  • To present current testing recommendations for cell substrate safety.

Main Methods:

  • Review of safety issues concerning adventitious agents in cell substrates.
  • Analysis of risks associated with tumorigenic and genetically engineered cells.
  • Evaluation of current and additional testing strategies for novel cell substrates.

Main Results:

  • Adventitious agents (exogenous, indigenous, endogenous retroviruses) pose significant risks.
  • Genetically engineered cells may generate recombinant viruses.
  • Tumorigenic cell substrates present theoretical oncogenicity concerns.

Conclusions:

  • Rigorous safety testing is crucial for novel cell substrates used in biologics.
  • Specific assays are recommended for tumorigenic and genetically engineered cell substrates.
  • Ensuring the safety of cell substrates is paramount for biologics efficacy and patient safety.