Formulation and Drug Delivery, Biologic Drugs

Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

Jessica Rousset, chief operating officer, CURE Pharmaceutical, highlights some key regulatory considerations developers should keep in mind when approaching alternative dosage forms.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

Optimizing the patient experience and technological advances can positively impact adherence.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

The companies will collaborate to bring InnoCore Pharmaceuticals’ proprietary SynBiosys biodegradable polymer platform to market.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.

Siliconization is a key process step in the manufacturing of prefilled syringe systems.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.