Formulation and Drug Delivery

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

Biocon Biologics will acquire Viatris’ global biosimilars business, including the company’s portfolio of in-licensed biosimilar assets, in a transaction valued at over $3.3 billion.

BioMed X and Boehringer Ingelheim have announced the start of a new research project in brain sensor development.

EMA has recommended approval of Spikevax for children aged 6 to 11.

AstraZeneca and Honeywell will partner to develop next-generation respiratory inhalers as part of AstraZeneca’s Ambition Zero Carbon program.

Scottish Enterprise has awarded £20 million (US$27 million) to Valneva Scotland to advance vaccine development.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.

The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.

Thermo Fisher Scientific is expanding its Millersburg, Penn., site with a $40 million investment to support increased production of single-use technology for critical vaccines and biologics.

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview Sean Tucker, PhD, chief scientific officer of Vaxart, on developing oral recombinant vaccines.

PharmTech interviewed Sartorius about SUS innovations and trends.

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.

In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

Toxicology studies are an important and required aspect of drug development that are performed to ensure that drugs are deemed safe prior to patient administration and use in clinical trials.

Arranta Bio will use Cytiva’s FlexFactory single-use manufacturing platform to produce mRNA vaccines.

A key benefit for companies when outsourcing formulation development is the broad experience they can gain from a dedicated service provider, particularly for niche markets.

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

Catalent has expanded its Malvern, Pennsylvania, USA, and Dartford, UK, facilities to provide advanced containment capabilities for the micronization of highly potent drug compounds.

Stevanato Group has extended its licensing agreement with Haselmeier for its Axis-D pen injector technology.

A report by international regulators reviews the effectiveness of current COVID-19 vaccines against the omicron variant.

Protective external packaging ensures COVID-19 vaccines arrive safely.

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.

Intravacc is partnering with Leiden University Medical Center for the development and evaluation of a new intranasal coronavirus vaccine candidate in a clinical Phase I/II study.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

Workforce training is crucial for biopharmaceutical manufacturing.

Dosage form and patient needs drive excipient choice.