Dosage Forms

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Gernot Warnke, Head of R&D, JRS Pharma, spoke about excipients and how these relate to feeding in batch and continuous manufacturing.

Sharon Nowak, Business Development Manager, Coperion K-Tron USA Food & Pharmaceutical Industries spoke about feeding equipment in solid-dosage drug manufacturing.

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Fernando Muzzio, PhD, Distinguished Professor of Chemical and Biochemical Engineering at Rutgers University, spoke about trends in continuous manufacturing of OSD drugs.

Johannes Khinast, PhD, Institute for Process and Particle Engineering in the Research Center Pharmaceutical Engineering (RCPE) at the Graz University of Technology in Austria, spoke about continuous manufacturing of OSD drugs.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

Dave DiProspero, director of Pharmaceutical Process Technology at CRB, spoke about equipment trends in solid-dosage drug manufacturing.

Alternative drug delivery approaches are promising, but due to their complexity, they need to be sufficiently justified.

Best practices help mitigate generic drug shortages.

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

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.

Conventional and robotic automation inside closed systems reduces risk.

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

Alternatives to animal testing and in-vivo assays are occurring as a result of recent scientific advances.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.

Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.

When designing and manufacturing a pMDI or DPI combination drug-delivery device, the commercial stage should be kept in mind from the beginning of development.

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.

Signal Rx Pharmaceuticals, Crystec, and ADYA Consulting are collaborating on the development of an inhaled dry powder formulation of SF2523 to treat pulmonary fibrosis, lung cancer, and SARS-CoV-2 related illnesses.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.