Formulation and Drug Delivery, Combination Drugs

Distinguishing E&L Testing for Combination Products (AAPS PharmSci 360)

November 06, 2023

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, talks about the differences in designing E&L testing for combination products vs. conventional pharmaceuticals.

Key E&L Issues to Consider During Formulation (AAPS PharmSci 360)

November 03, 2023

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.

Phase III Study for Novel Ganaplacide/Lumefantrine-SDF Combination in Adults, Children with Malaria Announced

November 29, 2022

The decision to move forward in Phase III development stems from the threat of resistance to current malaria treatment growth.

Advances in Drug Delivery and Areas for Improvement

September 02, 2022

While a variety of innovations have already impacted the drug delivery landscape, improving sustainability and having the ability to make smaller volumes of drug products still require work.

Exploring the Optimization of Linker Chemistries for ADCs

December 13, 2021

A look at how linker technology for antibody drug conjugates has evolved.

AstraZeneca’s AZD7442 Clinical Trial Meets Primary Endpoint

October 12, 2021

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

November 10, 2017

The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Nemera Receives Drug Manufacturing Authorization for its Autoinjector Facility

September 28, 2017

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

Engineered Proteins as Tools in ADC Development and Manufacture

April 01, 2017

OrlaSURF technology can be used for the development of target-binding assays to monitor the binding of an ADC to its antigen.

Being Thorough When Transferring Technology

March 01, 2017

Communication and taking the time to develop the process are key to successful transfer and scale up of biologics