From The Stage

Update on CAR T-Cell Therapies for the Treatment of Cancer

Posted by BioAgilytix / / Uncategorized

Chimeric Antigen Receptor (CAR) therapies are a type of cell therapy that consists of modifying immune cells to attack various forms of cancerous cells. While this is a relatively new therapeutic class, there are already a number of versions that are being developed or already approved for treatment.  Let’s start with the source of the cells being modified. In general, there are two categories of CAR immune cells: Autologous and Allogeneic. Autologous CAR therapies are derived from the patient’s own cells while allogeneic CAR therapies are typically taken from healthy donors…

Challenges for Measuring Immunogenicity of AAV-based Gene Therapies

Posted by BioAgilytix / / Uncategorized

Gene therapy is a powerful form of treatment that involves introducing genetic material into cells to replace defective genes resulting in the production of an essential protein. If a defective gene causes a required protein to be faulty or absent, gene therapy may be able to restore the protein’s function by introducing a “healthy” copy of the gene.Since gene therapy products work by introducing genetic material into the cell, scientists need a way to deliver DNA, RNA, or nuclease to the target tissue and cells. The delivery systems that carry…

Cell-Based nAb Assays: What We Need to Know

Posted by BioAgilytix / / Uncategorized

Cell-Based nAb AssaysSo, how do we deal with the nAbs when it comes to the industrial production of biotherapeutic agents? The bioanalytical community adopts a tiered approach to tackle the problem of nAbs. Firstly, any study samples in question are first screened and confirmed for the presence of binding antibodies via an established immunoassay. If the sample tests positive for binding antibodies, it is then examined for any drug-specific neutralizing ability in a nAb assay. Standard immunoassays such as enzyme-linked immunosorbent assays (ELISA), electrochemiluminescent (ECLIA) and other assays can detect…

Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market

Posted by BioAgilytix / / Gene Therapy, Industry Update

Cell and gene therapies have gone through a growth spurt in the last decade. According to data from the Alliance for Regenerative Medicine (ARM), during the first three quarters of 2020, regenerative medicine research and development broke records at nearly $16 billion in global financing. From the treatment of knee injuries to osteoarthritis, certain cancers and even muscular dystrophy, advances in gene and cell therapies have definitely caught the attention of medical professionals, and for good reason. Cell and Gene Therapies Account for a Large Portion of Therapeutic Market Share…

BioAgilytix Team Q&A: Meet Chris Carlin

Posted by BioAgilytix / / BioAgilytix Insight, CRO Selection

Tell us a little about your background and how you came to join BioAgilytix. My first wet lab experience was gained during my undergrad studies at Bowdoin College in southern Maine. I majored in biology and completed an honors thesis through an exploratory study of an uncharacterized genetic locus in a pathogenic yeast. Thereafter, I moved to Boston and worked for three years at the Ragon Institute of MGH, MIT and Harvard, where I analyzed expression profiles of proteases in the blood cells of HIV+ patients. I then transitioned into…

BioAgilytix Team Q&A: Meet Reema Davis

Posted by BioAgilytix / / BioAgilytix Insight, CRO Selection

Tell us a little about your background and how you came to join BioAgilytix. I did my doctoral and postdoctoral training in Cell Biology. My fascination with blood and lymphatic vessels led me to research their genetic make-up and related diseases, in hopes to find potential drug targets. During my research I trained extensively in cell-based work including but not limited to gene expression studies, intracellular signaling, cellular staining, transduction, all of which helped me build a strong foundation of transferable skills. I interviewed at BioAgilytix through Hannah Powell’s referral…

BioAgilytix Team Q&A: Meet Nikhil Soni

Posted by BioAgilytix / / BioAgilytix Insight, CRO Selection

Tell us a little about your background and how you came to join BioAgilytix. Some of my friends at my previous job joined BAL and told me about how much they liked it here. What is your current role, and how has it evolved since joining the team? Scientist III/BPM. Since joining the team I’ve had 4 analysts and scientists added under me. Along with that I’ve been given the responsibility of managing all aspects of multiple large studies. This has given me a lot of experience in both project…

CMC Requirements for Cell and Gene Therapy for IND Applications

Posted by BioAgilytix / / Regulatory Considerations

The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene therapies. The focus of the guidance is on SISPQ (safety, identity, strength, purity and quality), critical quality attributes (CQAs) and risk assessment. These apply to new cell/gene therapy products that have been developed in recent years. The FDA’s requirements, updated in January 2020, cover critical factors such as: Specification/characterization of manufacturing materials Filing and submission practices (i.e. eCTD or not) Manufacturing processes/procedures Product testing considerations…

FDA RACE for Children Act: What You Should Know

Posted by BioAgilytix / / Industry Update

Short for Research to Accelerate Cures and Equity, the RACE Act went into effect on August 18, 2020, and significantly increased the number of required studies devoted to pediatric cancer research, drugs, and therapies. Originally enacted in August 2017, as a part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), the RACE Act is an amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA) which was created to extend user-fee programs for drugs, medical devices, and biosimilars, as well as other biological products. Key Factors of the…

The Benefits of Outsourcing R&D Processes to CROs

Posted by BioAgilytix / / CRO Selection

As a leading contract research organization (CRO), BioAgilytix helps companies around the world with research and development, leveraging expertise in cell-based assays, immunogenicity, biomarkers and pharmacokinetics. We perform assay development and validation as well as sample analysis, lot release testing and ongoing data surveillance after drug products are introduced to market. Committed to helping reduce drug development timelines and costs, we are not alone in this growing industry. In fact, our work represents the larger-scale trend of pharma companies outsourcing R&D to CROs specializing in state-of-the-art technologies and expertise. The…