Formulation and Drug Delivery

DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

Sanofi’s acquisition of Origimm Biotechnology will add to its pipeline of vaccine candidates for treating acne.

Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.

Increased patient-centricity and alternative dosage forms require careful consideration when selecting the best taste-masking approach.

CordenPharma will build a clinical trial development facility for manufacture of oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

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.

Pfizer’s PAXLOVID oral solid-dosage treatment is designed to combat SARS-CoV-2 in high-risk patients at the first sign of infection.

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

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

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.

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

Investing in formulation strategies earlier on in development will maximize the chance of success.

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

Best practices help mitigate generic drug shortages.

SEDDS and SMEDDS improve solubility and permeability while expanding efficacy and applicability.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

Crystec and Biosidus have joined forces to enhance the delivery and performance of biotherapeutics.

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.