Formulation

The complexity of newer biotherapeutic molecules calls for alternative drug delivery strategies.

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Establishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.

Syngene International appoints two US-based executives to senior level positions.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.

Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.

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

DFE’s new line will offer market purity and low endotoxin excipients for use in formulation, while providing drug developers and manufacturers high-quality excipient technology and services.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

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

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.

Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.

The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.

Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.