Drug Development

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.

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

Ferrer and Treeway, have entered into a license agreement for the development and commercialization of an oral formulation of edaravone (TW001/FNP122).

Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years

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.

MilliporeSigma announced the opening of its second Carlsbad, California-based facility, which doubles production capacity to support commercial and industrial manufacturing of viral vectors.

The ever-increasing interest in photochemistry has inspired the development of innovative, modular flow photochemistry reactors.

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.

Advanced powder testing is a useful tool to differentiate materials and optimize the supply chain.

Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication.

Between dosage form versatility, product stability, lack of storage restrictions or need to refrigerate, and an easier means of purification, small-molecule APIs present an appealing market niche.

Pharmalex has launched the Biopharma Excellence brand, a new service line that combines the expertise of PharmaLex, ERA Consulting, and Biopharma Excellence.

The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.

The Pharmaceutical Technology and BioPharm International editors host industry experts, highlighting trends and new technologies.