Manufacturing

Experts share best practices in designing, manufacturing, and scaling up dry powder inhaler and metered dose inhaler drug–device combination products for inhalation drug delivery.

A multilayered processing approach ensures safe handling and content uniformity of highly potent APIs.

Advanced powder testing is a useful tool to differentiate materials and optimize the supply chain.

Back in person at the Javits Center, exhibitors present containers, components, equipment, and services to fill, ship, protect, and optimize the packaging process.

Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication.

New enzymes and protein engineering have advanced biocatalysis processing toward commercial acceptance. Technology and economic roadblocks must be overcome for the process to be widely embraced by pharma.

Between dosage form versatility, product stability, lack of storage restrictions or need to refrigerate, and an easier means of purification, small-molecule APIs present an appealing market niche.

CPhI is set to provide the pharma community with an ideal platform to engage with new value chain stakeholders post-COVID.

Aceto will acquire A&C Bio Buffer, including the company’s custom buffer and chemical blend portfolio.

The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.

The Pharmaceutical Technology and BioPharm International editors host industry experts, highlighting trends and new technologies.

Avid Bioservices is building a viral vector development and manufacturing facility near its existing biologics manufacturing facility in California.

Smiths Detection has confirmed that the Bioflash air sampler can detect Beta, Gamma, Kappa, Delta, and Delta plus variants.

Pfizer may pay up to $630 million for access to Voyager’s novel AAV capsids in transgene research.

Moderna’s new facility is expected to produce 500 million vaccine doses per year.

The $3 million investment will go towards various projects investigating key product attributes for therapeutic proteins.

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.

New excipients for protein-based drug products reduce viscosity while maintaining protein stability.

Thermo Fisher’s new Swiss facility will initially produce CSL Limited’s recombinant factor IX product Idelvion.

Conventional and robotic automation inside closed systems reduces risk.

Evolving equipment designs meet the unique needs of continuous processing techniques.

Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.

The new LabVantage Enterprise SaaS adds full configurability and custom interfacing capabilities.

NewAge Industries has completed a plant expansion that added new cleanrooms to its headquarters in Southampton, Pa.

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.