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Drug Substance Manufacturing Articles & Analysis: Older
22 articles found
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 ...
Whether it is medical research or drug manufacturing, tablet press is a vital link. Let's see how to choose the one that suits you best.Grand pack.The field of drug delivery is constantly evolving, driven by the core goal of improving therapeutic outcomes—enhancing efficacy, reducing toxicity, boosting patient compliance, and even enabling entirely new medical treatments. The global drug delivery ...
Nanogels (NGs), namely nanoscale hydrogel particles, are three-dimensional network systems formed by physical or chemical cross-linking of polymers. Nanogels have received widespread attention in recent years due to their unique properties and potential applications in various fields such as drug delivery, tissue engineering, and diagnostics.Classification of NanogelsAccording to the phase change ...
Microneedle patch technologies have revolutionized the field of drug delivery, offering a wide range of advantages over traditional methods. These innovative patches provide a minimally invasive and painless alternative to injections while ensuring precise and controlled drug administration. In this article, we will explore various types of microneedle patch technologies, including ...
Patient-centric drug development is a divisive concept. Dismissed as a buzzword by some. Adopted extensively by others. It has, nevertheless, gained enormous traction over the last decade. This new approach to treatment incorporates patient perspectives into drug development. A key benefit is the keener focus on convenience and safe drug administration. Traditional approaches, prioritising ...
The generic pharmaceutical industry is fiercely competitive, with each company striving to add new products and expand its portfolio. However, not all companies possess the necessary resources to undertake such endeavours. Some lack the requisite experience in commercial-scale production using the latest technology, while others lack the capacity to ramp up manufacturing. ...
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 ...
Metformin is a classic first-line hypoglycemic agent for patients with type 2 diabetes, and is an essential drug in combination regimenes. However, as the evidence is updated, the idea of drug selection for first-line treatment is changing. GLP-1 agonists and SGLT-2 inhibitors in combination with or without metformin (as required for glycemic management) have also been recommended by multiple ...
COVID -19 Vaccine Overview The development of a COVID-19 vaccine by drug manufacturers has been welcomed across the globe. A key concern, however, is the safe distribution of the vaccines worldwide. This may cause some challenges for certain vaccines. Certain vaccines must be kept at an extremely cold temperature of -70°C (-94F), much lower than the average temperature capabilities of an ...
In addition, experts have found that tetracyclines are susceptible to cations such as calcium, magnesium, zinc, iron, and form poorly soluble or insoluble complexes, thereby greatly reducing the effect of tetracycline pharmaceutical preparations. Drug manufacturers should avoid using some metal salts as excipients when developing and producing such preparations. ...
In addition, experts have found that tetracyclines are susceptible to cations such as calcium, magnesium, zinc, iron, and form poorly soluble or insoluble complexes, thereby greatly reducing the effect of tetracycline pharmaceutical preparations. Drug manufacturers should avoid using some metal salts as excipients when developing and producing such preparations. ...
The purpose of the stability testing is to investigate how the raw materials or pharmaceutical preparations will change over time under the influence of temperature, humidity, and light, so as to provide a scientific basis for the production, packaging, storage, and transportation conditions of the drug, and to establish the validity period of the drug through the test. In addition to humidity ...
Introduction “Our priority is to provide our customers with the high purity water and steam that is critical to the development and manufacturing of life-saving medications now and for future generations.” —George Gsell, MECO President Nexus Pharmaceuticals, maker of difficult-to-manufacture, high quality, FDA-approved specialty and generic drugs, is opening a $250 million, ...
Due to a lack of robust in vivo gut models, animal studies are generally required to evaluate gut toxicity. However, these studies can be lengthy and expensive and may not accurately recapitulate the behavior of the human gastrointestinal tract. Drugs are thus often developed with undesired gut side effects that are not apparent until clinical trials. Organ-on-a-chip models are the closest ...
In this context, we review here the manufacturing costs at scale for nanobodies, and ask whether their production costs are really cheaper than CHO-produced mAbs. ...
The risk? According to Medicinenet.com, only 5 in 5,000 drugs that enter preclinical testing advance to human trials. And only 1 of these 5 drugs ultimately gets approved for sale, which means the chance for a new drug to make it to market is 1 in 5,000. That’s a lot of R&D ...
Few sectors are as captive to water requirements and regulations as the biopharmaceutical industry. Water is a critical component in the manufacture of active pharmaceutical ingredients (APIs), life-saving drugs, vaccines, PPE, testing kits and many more products. To gain a clear picture, water for industrial use represents a significant part of global water demand and if nothing is done to ...
Pharmaceutical firms research, develop, and manufacture over-the-counter and prescription drugs and medicines. Usage of these drugs includes, but is not limited to, vaccinations, treatment for chronic conditions, and pain management. To protect the health and well-being of the public, the pharmaceutical industry is one of the most highly regulated industries. For instance, in the United States, ...
Abstract: Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of cGMP Controlled Raw Materials is critical to Life sciences personnel to ...
Section 6002 of the Affordable Care Act (ACA) of 2010 – also known as the Physician Payments Sunshine Act (PPSA) – requires all manufacturers of drugs, medical devices and biologicals that participate in US federal healthcare programs to disclose any and all payments or other transfers of value made to physicians or teaching hospitals. It also requires disclosure of any physician ...