Blog | HemaCare

HemaCare Publication Highlights Role of Cell Therapy Starting Materials

Jan 7, 2020 10:04:00 AM / by Nancy Andon, MSc posted in Gene Therapy, Cell Therapy

0 Comments

HemaCare Corporation’s latest publication in BioPharm International [1] sheds light on a topic that has been preoccupying some of the best minds in cell therapy research; the need to ensure a reliable supply of top-notch starting materials for up-and-coming cell and gene therapies.

Unlike traditional medical treatments, the raw materials for these therapies cannot simply be manufactured. Instead, the supply of starting materials relies on a steady influx of voluntary donors willing to take the time to undertake a fairly complex screening process and donate peripheral blood or bone marrow for altruistic reasons. Nor is a reliable donor pool the only criteria necessary to supplying materials for a successful cellular therapeutic. Starting material quality and consistency ultimately determine the reliable efficacy of the final product.

Read More

The Changing Landscape of Clinical Approval

Aug 27, 2019 10:04:00 AM / by Nancy Andon, MSc posted in Gene Therapy, Cell Therapy, Drug Discovery

0 Comments

HemaCare is pleased to announce the publication of our latest article [1] in the journal International Clinical Trials (ICT). The paper, entitled “The Landscape of Clinical Approval” describes how changes in the clinical drug approval process are impacting starting material suppliers, and what suppliers are doing to meet increased demands.

Read More

HemaCare Aids Strategy for Boosting Gene Therapy Efficiency

May 21, 2019 10:06:00 AM / by Nancy Andon, MSc posted in Gene Therapy, Bone Marrow, Stem Cells

0 Comments

An independent publication cites the use of bone marrow and mobilized peripheral blood sourced from HemaCare in a study aimed at improving the efficiency of resource consumption in gene therapy.

The publication, published in the journal Molecular Therapy, focuses on the use of lentiviral vector (LV) to introduce corrected versions of defective genes into stem cells. The goal of gene therapy is to transplant these stem cells into people suffering from genetic disease, in hopes of restoring the function of the faulty gene. One of the main challenges in this clinical strategy is the cost; substantial amounts of LV are needed to modify a therapeutically effective dose of stem cells.

Read More

Minimizing Risk from the Start: HemaCare Publication Spotlights Starting Material Logistics

May 14, 2019 9:21:09 AM / by Nancy Andon, MSc posted in Gene Therapy, Cell Therapy, quality control

0 Comments

As the industry and regulatory landscape continues to evolve, it’s vital that as an industry, we take a lifecycle approach to risk management –to ensure that we mitigate as much risk as possible all the way from discovery through to commercialization.” - Dr. Dominic Clarke, Global Head of Cell Therapy, HemaCare

Cell and Gene Therapy Insights has just published HemaCare’s white paper on how to manage starting material quality and stability to maximum effect during cell therapy manufacturing. [1] Quality cell therapies can only be created from quality starting materials, yet paradoxically, starting materials are the single greatest source of variability in the cell therapy manufacturing process. Mitigating risk requires minimizing that variability, and also managing shelf-life limitations and biopreservation logistics.

Read More

FDA Policy Changes will Accelerate Cell and Gene Therapy Approvals

Feb 21, 2019 10:02:00 AM / by Nancy Andon, MSc posted in FDA, Gene Therapy, Cell Therapy, GMP Cellular Therapeutics

0 Comments

The U.S. Food and Drug Administration (FDA) has announced that they are adding staff and rolling out policy changes aimed at advancing the development of safe and effective cell and gene therapies. [1] The announcement came in the form of a press release on January 15th, citing that the new policies are a response to the current surge in cell and gene therapy products that the agency is handling. Based on the number of investigational new drug (IND) applications being submitted, the FDA projects a significant rise in the number of therapies that will be approved over the next few years:

Read More

      Subscribe Here!

      Posts by Topic

      see all

      Recent Posts