Drug Development

Polymeric amorphous solid dispersions are the most commonly used technology, but amorphous APIs remain inherently unstable.

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.

Chinook Therapeutics has formed a 50/50 joint venture with investors to develop kidney disease therapies in China.

Researchers from MIT have developed novel nanosensors for the detection of the nucleocapsid and spike protein of the SARS-CoV-2 virus.

BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.

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.

Takeda has exercised an option to co-develop and co-commercialize an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin.

Secarna Pharmaceuticals and Achilles Therapeutics have entered into an agreement to optimize the development of T cell therapies in Achilles’ pipeline.

CGT Catapult and Deep Science Ventures have partnered to encourage innovative approaches to overcoming barriers in delivering advance therapies to patients.

Sterling Pharma Solutions has announced a £10 million (US$13.5 million) investment into process development and manufacturing capacity at its site in Dudley, UK.

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

Under the expanded agreement with Agios, Centogene will provide global clinical trial support for thalassemia and sickle cell diseases.

Fujifilm is expanding its R&D footprint at its California facility.

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

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

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

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

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

The researchers will use 3D printing to design novel flow reactors and static mixers.

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

Advances in simulation and the development of digital twins.

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.

The $691 million deal will see Vertex use Mammoth’s systems to discover and develop in-vivo gene-editing therapies.

The National Institutes of Health (NIH), FDA, and fifteen private organizations are partnering together to form the Bespoke Gene Therapy Consortium.

Ajinomoto and its subsidiary company, Ajinomoto Genexine, have partnered with Insilico Biotechnology to accelerate and improve process development and production of biologics using digital twin technology.

Spectrum Chemical scientists give a shout-out to 10 chemicals impacting quality of life in conjunction with National Chemistry Week.