The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
Training is crucial for supporting GMP operations in commercial-scale bioprocessing.
The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
Discover why integrating Human Factors and patient activities from early device to manufacturing is essential to develop a patient-centric inhaler.
The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
Study results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
The European Union aims to become the most attractive place for life science by 2030.
As the conference approaches, scientists are reviewing new technologies that enhance manufacturing process control, product integrity, and regulatory compliance through automation and sustainable materials.
During the past few years, we've seen a growing interest in direct oral application products, evidenced by the large amount of products already available on the market.
Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.
Predictive computational methods are finding wider use in pharmaceutical solid dosage development, particularly in mixing and blending, to improve tech transfer and equipment selection, and speed the acquisition of process understanding.
Ensuring reliable analytical methods and bioassays requires a well-thought-out strategy for evaluating method validity and systems suitability.
Sponsors should explore key considerations ahead of choosing a new outsourcing partner.
With the increasing importance of novel dosage forms, the use of release liners as components of transdermal delivery systems, oral thin films and buccal mucosal systems is on the rise.
With economics and politics in the way, can we defeat the malaria epidemic before it defeats us?
The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.
Best practice methods for the tech transfer of CGTs can increase process and analytics robustness while remaining scalable.
Tests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.
The authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.
An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years
Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.
There has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.