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Drug Master File Document Production Articles & Analysis
45 articles found
In the pharmaceutical industry, excipients play a crucial role in the formulation of medicines. These inactive substances, which are combined with the active pharmaceutical ingredient (API), perform various functions that enhance the effectiveness, stability, and overall performance of drug products. Understanding the common types of excipients is essential for pharmaceutical scientists and ...
As seasonal allergies affect millions globally, the demand for advanced, reliable treatments is growing rapidly. Behind the scenes of this progress lies a powerful class of materials: fluoropolymers. While often associated with aerospace, semiconductor, and chemical industries, fluoropolymers also play a vital—yet underappreciated—role in pharmaceutical manufacturing, particularly in ...
In the ever-evolving field of biopharmaceuticals, the production of antibodies has taken center stage due to their critical role in therapeutic applications. Among the various production systems available, Chinese Hamster Ovary (CHO) cells have emerged as a gold standard for monoclonal antibody production, and specialized services have been developed to streamline this process. The Significance ...
The MDCK permeability assay is a critical technique employed in pharmacology and drug development to evaluate the permeability of drug candidates across epithelial cell layers. This assay utilizes Madin-Darby Canine Kidney (MDCK) cells, which are a widely used model for studying intestinal absorption and permeability due to their similarity to human epithelial cells. Importance of the MDCK ...
Antibody-Drug Conjugates (ADCs) represent a groundbreaking advancement in targeted cancer therapy, combining the specificity of antibodies with the potency of cytotoxic drugs. The development and production of ADCs are complex processes that require a deep understanding of both biology and chemistry, alongside cutting-edge technology. This article delves into the intricacies of ADC development ...
Recombinant protein drugs refer to protein products that originate from animals and plants and are developed through biotechnology research. These protein drugs exhibit certain biological activity and can prevent, diagnose, and treat diseases in humans, animals, and plants. Compared with small molecular drugs, recombinant protein drugs offer advantages such as high activity, high specificity, and ...
Introduction The pharmaceutical industry faces stringent regulatory requirements to ensure the safety, efficacy, and quality of drug products. Among these, Current Good Manufacturing Practice (CGMP) guidelines set by agencies such as the U.S. Food and Drug Administration (FDA) play a pivotal role. Pharmaceutical CGMP manufacturing encompasses all processes that abide by these guidelines to ensure ...
Natural product extraction is a crucial process in the fields of chemistry, biology, and pharmaceuticals. It involves isolating bioactive compounds from plants, animals, and other natural sources to study their properties and potential applications in various industries. There are several methods used for natural product extraction, each with its advantages and limitations. One of the most ...
Watertown, MA, July 22, 2024 – Biopharma PEG, a top supplier of PEG derivatives, is excited to introduce its new line of monodispersed PEGs. These specially sized polymers are designed to improve the stability and delivery of proteins and peptides in drugs. They are essential for Antibody-Drug Conjugate (ADC) linkers, Proteolysis Targeting Chimeras (PROTAC) linkers, and PEGylated proteins ...
Host cell proteins (HCPs) are protein impurities produced by genetically engineered strains or cell lines. Some of these proteins are necessary for the survival, reproduction and other normal physiological activities of engineered strains or cell lines. HCPs are purified together with the target product during the production process and cannot be removed. Risks of HCPs In general, HCP ...
Pharmaceutical excipients play a crucial role in the formulation and production of drugs, supporting their stability, efficacy, and palatability. Among the numerous excipients used in pharmaceutical preparations, preservatives, stabilizers, suspending agents, thickener excipients, and flavoring agents are commonly observed. Understanding their functions and characteristics is essential for ...
Antibody drug conjugates (ADCs) are a new class of biopharmaceuticals that use monoclonal antibodies to target tumor cells to deliver potent cytotoxic drugs. So far, a total of 15 ADC drugs have been approved worldwide, of which the FDA has approved 13 ADCs for various cancers, including Adcetris®, Kadcyla®, Besponsa®, Mylotarg®, Lumoxiti®, Polivy®, Padcev®, Enhertu ®, Trodelvy® and Blenrep®. As ...
Medical devices are incredibly important in today’s world. They play a significant role in the treatment and prevention of various medical conditions. However, their effectiveness can be compromised if they are not packaged correctly. Packaging is an essential component of maintaining the integrity and shelf life of medical devices, especially during transportation and storage. Read on ...
Interleukin-2 (IL-2) is a 15kDa secretory protein with a 4-alpha-helical bundle structure. As a T-cell related growth factor, IL-2 can enhance the killing activity of NK cells and promote B cells to produce immunoglobulins. In addition, it aids in the development of regulatory T cells (Tregs), thereby producing peripheral T cell immune tolerance, as well as regulating the proliferation and ...
Solid-liquid separation is necessary in many industries for compliance, quality control, and efficient production processes. In the pharmaceutical industry, solid-liquid separation is conducted in applications such as biocatalysis, active pharmaceutical ingredient (API) purification, and chromatography, to name a few. The separation process can be carried out through a range of instruments, but ...
Drug-to-antibody ratio (DAR, drug-to-antibody ratio) The number of cytotoxic drugs connected to each antibody is the drug-to-antibody ratio (DAR). When the DAR increases, the drug metabolism rate of ADC drugs increases, the half-life decreases, and the systemic toxicity increases. Ideally, when the DAR is 4, the drug has the highest efficacy. Therefore, in actual production, the drugs with DAR ...
The pharmaceutical industry is a highly dynamic industry. It is constantly innovating new and complex drugs with great efficacy. This poses a challenge for generic companies to keep up and develop drugs that match the same level of complexity and effectiveness within a reasonable timeframe and budget. To address this challenge, generic companies often outsource their drug ...
Liraglutide and exenatide are both belonging to the class of diabetes products called GLP-1 analogues. The GLP-1 analogues have established themselves in the past years as one of the superior drug classes for treatment of diabetes type II in terms of blood glucose lowering and weight loss. Because of the latter, they are being used more and more also in the treatment of obesity. Until now, both ...
Revisiting the “why” behind decision making can be a helpful exercise in all aspects of business. This is no less true for clinical operations executives when it comes to the clinical trial systems they employ to facilitate their teams’ work. The technology that supports clinical trial systems has evolved steadily over the past several decades, yet the ultimate goal of ...
Executive Summary Futura Medical's novel OTC topical erectile dysfunction treatment MED3000 will be launched across numerous European markets by France's Cooper Consumer Health. You may also be interested in... Futura All Set For US FDA De Novo Application For Eroxon OTC ED Treatment Futura Medical is preparing to seek approval from the FDA to launch OTC in the US its MED3000 erectile ...