Dosage Forms

Modeling the manufacturing process benefits both development and operations.

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

Container and equipment innovations expand applications.

Vaccines define the path to putting the pandemic in the rear-view mirror.

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

Modified-release dosage forms present new opportunities for drug developers and can help overcome challenges, such as short biological half-life or poor bioavailability due to degradation in the stomach.

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

CPI has revealed an agreement with DFE Pharma, making it the latest partner of the Medicines Manufacturing Innovation Centre (MMIC) collaboration.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.