Formulation

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.

At BIO 2024 in San Diego, John Dunlop, PhD, chief scientific officer at Aliada Therapeutics, sat down for an interview with BioPharm International to discuss the firm’s MODEL platform and its potential impact on therapeutic delivery for brain-related conditions.

Swiss CDMO CordenPharma and Spain-based Certest will collaborate on the development of ionizable lipids for LNP formulations.

Using a multi-pronged strategy to find optimum, tailored formulations is best.

Progression in biopharmaceutical drug development and manufacturing is being boosted by technological advances.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

This article represents a comprehensive exploration about biopharmaceutical excipients, exploring their multifaceted classification, active role in drug formulation processes, inherent challenges, and upcoming advancements poised to revolutionize the drug formulation and its efficacy for patient welfare.

Proprietary cell lines offer opportunities for achieving high AAV titers.

CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

Preparing for variability and flexible processing are necessary for success.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

There is no such thing as a perfect linker.

Sara Fathollahi, PhD, product application specialist at DFE Pharma, makes the case of how excipient suppliers can support the transition from batch to continuous manufacturing.

Biologics formulation comes with a unique set of challenges, which can be overcome through innovative strategies and good partnerships.

Despite its success, clinical and logistical roadblocks to mRNA cancer vaccine development remain.

Nanoparticles offer the potential for a safer, more effective method of drug delivery to the patient.

When one is using continuous hot-melt extrusion to enhance solubility, process control is essential.

This deal would help the companies merge to work on future projects and conduct research together.

Presspart will still be responsible for the manufacturing of the Sunriser device.

Advancements in therapeutic modalities are necessitating change in drug delivery to help negate some of the expense of development and manufacturing.

Polyplus’ LipidBrick is designed to expand the scope of lipid nanoparticle formulation usage in mRNA therapeutics and vaccine development.

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.

Particle engineering can be a resourceful tool to advance drug candidates by offering drug delivery innovation.

Companies need to consider and address formulation challenges to employ a successful reformulation strategy.

There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.

Research into oncolytic viruses potentiated by stem cells shows promise for treating cancer.

Manufacturing and processing challenges surrounding mRNA can be overcome in order to realize the true potential of a technology 30 years in the making.

Using an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.