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CAR-T cancer, technology, chemotherapyCustom Manufacturingdisease, researchgenetic sequencing,, drug development
February 18, 2025

CAR-T

Introduction: Chimeric Antigen Receptor (CAR) T-cell therapy is advancing cancer treatment with a personalized approach that reprograms a patient’s own immune cells to target and kill cancer cells. Originally developed for hematologic malignancies, CAR-T therapy has shown strong promise in treating otherwise difficult cancers. This therapy presents a unique opportunity for the development of novel oncological and immunotherapy drugs. T-cells are harvested from a patient’s blood sample, and a viral or non-viral vector is used to introduce the genetic instructions to create the CAR. The vector is a delivery system that introduces the CAR gene, enabling the cell to produce these specific receptors. After these trained cells multiply, they are reintroduced into the patient and multiply in the bloodstream. These cells are now able to detect cancer cells that have hidden from standard immune identification. Development: CAR-T therapy has evolved from a long lineage of immunotherapy milestones—from 19th-century bacterial-based approaches such as Coley’s Toxins and BCG vaccine studies to modern…
Jason Kaimana 0
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The Rise of GLP-1 Drugs Custom Manufacturingdisease, researchgenetic sequencing,, drug developmenthealth, diet
January 16, 2025

The Rise of GLP-1 Drugs

The Rise of GLP-1 Drugs  Glucagon-like peptide-1(GLP-1) agonist drugs have emerged as one of the most significant breakthroughs in recent pharmaceutical history. Designed for managing Type 2 diabetes, these drugs have made news headlines and skyrocketed in popularity for their effectiveness in weight loss.   Transition from Diabetes to Weight Loss:  The GLP-1 hormone was first identified by researchers at Massachusetts General Hospital in 1986 as a glucagon precursor. This quickly found commercial applications for managing conditions such as diabetes with Novo Nordisk developing liraglutide in 1990s. This eventually led to the development of semaglutide in 2012, with a similar mechanism of action, but slower onset of effect and longer duration of action. Initially designed for diabetes treatment, the FDA approved Ozempic in 2017. Researchers noted in clinical trials that participants lost 10-15% of their body weight, prompting further applications for weight loss and obesity. Wegovy, another semaglutide-based formulation, uses a higher dose specifically for weight loss and achieved FDA approval…
Jason Kaimana 0
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Big Data Meets Big Pharma BusinessData ManagementPharmaceutical Development
June 7, 2024

Big Data Meets Big Pharma

Burgeoning Data The amount of data generated daily has grown exponentially in recent history. According to an article by Fabio Duarte, almost 329 million terabytes of data are generated each day, totaling 120 zettabytes annually (1 zettabyte = 1,000,000,000,000,000,000,000 bytes). Sensors on manufacturing equipment generate data based on current conditions and equipment performance. IoT devices can process this data to make immediate adjustments for optimal performance, quality, and regulatory compliance. Processing this “big data” efficiently can be a major source of competitive advantage for pharma companies. Big Data Analytics Aggregated data generated by equipment-bound sensors can differ from the data found in traditional datasets and processed by analytical methods. Traditional analysis focuses on static data and historical trends but is less effective with high-volume, real-time data. Data veracity is vital to transforming data into usable information; big datasets have a huge pool of data to offset outliers and reduce human error during analysis. Big data frameworks like open-sourced Hadoop and…
Justin Cesnavicius 0
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CMC Consutants, Gmp,Good,Manufacturing,Practice,Medicine,Pharmacy,Сoncept.,Quality,Control,Standards
Who Needs CMC Consultants? You do. CMC ConsultingPharmaceutical ConsultantPharmaceutical Development
February 23, 2023

Who Needs CMC Consultants? You do.

The pharmaceutical industry is a highly regulated field that requires attention to detail at every stage of product development. The Chemistry, Manufacturing, and Controls (CMC) aspect of drug development is critical, as it involves ensuring the safety, quality, and efficacy of the final product. CMC consultants are professionals who specialize in providing expert advice and guidance in this field, and they can be an invaluable asset to pharmaceutical companies throughout the development process. Regulatory Compliance One of the primary benefits of hiring a pharmaceutical CMC consultant is their expertise in regulatory compliance. The pharmaceutical industry is heavily regulated, and there are numerous guidelines and regulations that companies must adhere to in order to bring their products to market. CMC consultants are well-versed in these regulations and can help companies navigate the complex regulatory landscape, ensuring that their products meet all the necessary requirements. Cost-Effectiveness Developing a new drug can be a costly and time-consuming process. Pharmaceutical CMC consultants can help…
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QMS, QA, Release Testing
Is Your QMS Up to the Task? Quality Assurance
December 15, 2022

Is Your QMS Up to the Task?

What is a Quality Management System (QMS)? A QMS is a set of policies, procedures, and processes that are put in place to ensure that a product meets the required quality standards. In pharmaceutical manufacturing, a QMS is put in place to ensure that products are produced consistently and meet regulatory requirements. A QMS includes processes such as quality control, quality assurance, and quality improvement. Why is a QMS Important in Pharmaceutical Manufacturing? The implementation of a robust Quality Management System in pharmaceutical manufacturing is crucial for several reasons: Compliance with Regulatory Standards The pharmaceutical industry is highly regulated, and regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require that pharmaceutical manufacturers comply with strict regulations to ensure the safety and efficacy of their products. A Quality Management System is an important tool, among many, that a manufacturer uses to help with compliance with these regulations, reducing the risk of non-compliance and…
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