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…
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 Originally enacted in August 2017, as a part of the Food and Drug Administration (FDA) Reauthorization Act (FDARA), the RACE Act is an amendment to the Federal Food, Drug, and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…
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…
Tumor tissue biopsies have been the traditional method of identifying and analyzing cancer cells. But in addition to being invasive and risky, they have many limitations. Tumor accessibility is often problematic as are issues with monitoring the progression of disease. Tissue samples from a single location don’t always provide a full picture of a tumor’s genetic heterogeneity, limiting accuracy. The more data oncologists have about a patient’s cancer, including genetic information, the more precisely it can be diagnosed, treated, and monitored. Immunotherapy has quickly evolved as a promising treatment modality…
Short for Contract Research Organization, a CRO is a company that provides clinical research support to the pharmaceutical, biotech and medical industries on a contract basis. Contract Research Organizations are hired to offer research support and conduct clinical trials to safely and efficiently bring life-saving drugs and vaccines to market. Lasting partnerships between CROs and pharmaceutical companies are vital to the long-term success of ongoing programs and clinical trials. When a CRO fails to meet certain criteria relating to safety protocols or deadlines it can leave some companies questioning whether…
Cytokines are a broad class of soluble proteins, glycoproteins, and peptides that act as chemical messengers of the immune system. These small proteins are essential intercellular communicators that carry messages from one cell to another and contribute to cell growth and immune response. Cytokines include chemokines, interferons, interleukins, lymphokines and cannot cross the lipid bilayer of the cell wall to enter the cytoplasm. They have been shown to be key players in endocrine, autocrine and paracrine signaling as immunomodulating agents. Since cytokines help to regulate important functions in the human…
According to research compiled by Reports and Data, in 2018 the global biologics market was valued at over $250 million, but is projected to reach an estimated $625 million by the end of 2026 with an 11.9% compound annual growth rate (CAGR). Biologics are medications made up of proteins, sugars, or DNA, and oftentimes are a complex combination of these materials and by-products. Biologics can also be composed of living cells and tissues and come in a wide variety of products such as allergy medicines, vaccines, oncology treatments, therapeutics, amongst…
At the commencement of her national campaign in July 2016, the former UK Prime Minister Theresa May stated, “It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry.” This still holds true today. Despite this, according to the Freedom of Information Act, as of 2017, the number of EU academics and staff departing the United Kingdom was up by over 35% compared to years prior. In fact, many companies, Biotech included, have been leaving the UK for the Netherlands only adding to…
It’s that time of the year again. October 26th marks the beginning of the American Association of Pharmaceutical Scientists (AAPS) PharmSci 360 event. This yearly assembly of pharmaceutical scientists from across the globe is designed to share research and exchange ideas in the pursuit of global health and the betterment of humanity. PharmSci 360 draws thousands of the scientific community’s brightest minds in what is one the largest scientific conversations of the year in this segment of the pharmaceutical industry. It provides an excellent opportunity for us to network with…
If your goal is to attain swift and simple protein quantification, the Bradford assay is the way to go. Let’s find out more about what makes the Bradford assay so effective and relevant over 40 years after its inception. What is Bradford Assay? The Bradford protein assay, named after its developer Marion M. Bradford, is specifically used to calculate the concentration of total protein in a sample or solution. There are three standard methods to calculate and measure protein concentration and those are the bicinchoninic acid assay (BCA assay), absorbance…
