Formulation and Drug Delivery, Biologic Drugs

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

Gregor Kawaletz, head of Oral Solid Dose Business Unit at Recipharm, discusses the immediate future of oral biologics

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.

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

Some of the greatest advancements in drug delivery are related to disposable delivery devices, vaccine adjuvants, and wearable pumps, according to Nicholas W. Warne of Pfizer.

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

Novo Nordisk will expand its existing research collaboration in novel delivery technologies with MIT and Brigham and Women’s Hospital.

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

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

Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.

Vaccine development is inherently challenging; however, in light of the COVID-19 pandemic, innovations have been prioritized, leading to accelerated development processes.

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

CordenPharma announces expansion of lipid excipients supply for coronavirus vaccine scale up.

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

Considering the potential interaction of a drug with the delivery device early on in in development is integral to achieving the best combination.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

The need for manufacturing speed inspires contract manufacturers to explore advanced processing technologies.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.

On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.