Drug Manufacturing Articles & Analysis: Older
21 articles found
Ordinary nanogels will swell when absorbing water, and their drug administration and subsequent release behavior will be single. Environmentally responsive nanogels will swell or dissolve when exposed to different environments, and their administration and subsequent release behavior will be more intelligent. ...
Upon application to the skin, the microneedles dissolve, releasing the drug payload in response to the skin's temperature. This technology enables precise control over drug release kinetics, making it suitable for various therapeutic applications. ...
This new approach to treatment incorporates patient perspectives into drug development. A key benefit is the keener focus on convenience and safe drug administration. ...
For a generic Pharma Company partnering with a CMO has several benefits, some of which are as follows: Cost Savings One of the primary benefits of partnering with a CMO is cost savings. Manufacturing a large-scale drug for a pharmaceutical company is time-consuming and costly. By partnering with a CMO, generic pharmaceutical companies can save on ...
To address this challenge, generic companies often outsource their drug development to Contract Development and Manufacturing Organizations (CDMOs), which offer end-to-end services from research to commercialization. ...
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. ...
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. ...
Pharmaceutical excipients are substances formulated together with active pharmaceutical ingredients (APIs) of the drug, and excipients account for most of the drug composition. Excipients are designed to interact with and enhance the properties of APIs. ...
This is to say that relatively more drugs will enter the lymphatic circulation and at the same time avoid the first pass effect of the drug in the liver. ...
This is to say that relatively more drugs will enter the lymphatic circulation and at the same time avoid the first pass effect of the drug in the liver. ...
Generally, the use of nonlinear and other types of special linear models (such as sqrt, 1/x, logarithm, exponential, polynomial) should be avoided as they may produce meaningless and unreproducible drug expiration estimates. Measures to improve drug stability Based on the above analysis, the following measures can be considered to improve drug ...
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 ...
Clearly, fewer liabilities carried into the clinic will result in higher-quality drugs that reach the market more quickly. An Efficient Human Cell–Based Option RepliGut® tissue constructs from Altis Biosystems have the potential to address this critical need in pharmaceutical drug development. ...
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 ...
Water is a critical component in the manufacture of active pharmaceutical ingredients (APIs), life-saving drugs, vaccines, PPE, testing kits and many more products. ...
In previous blog posts, we have explored the fact that many drugs, vaccines and pharmaceutical products require refrigerated conditions in order to maintain efficacy. We also examined the importance of minimizing temperature excursions during transportation. Establishing a drug stability budget can minimize discards and ensure a quality product is delivered to the end-user. We know that ...
ByAKCP
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 ...
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 ...
Abstract: An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has ...