Formulation

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Aseptic fill/finish is crucial in biopharma manufacturing and is optimized through automated technology.

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

Advances in wearable devices have made it possible to deliver high-volume, high-viscosity biologics.

Sensors and devices being developed by nGageIT Digital Health Solutions can track patient use of oral solid-dosage or injectable drugs.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.

Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.

Biopharma employees reveal employment objectives, opportunities, and frustrations.

Germany tops quality ranking in the inaugural CPhI Global Pharma Index.

ADC Bio experts warn of impending problems in the ADC pipeline with millions wasted in development costs.

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.

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.

The company has officially opened a local brand office in South Korean to support its existing business in the region.

Siliconization is a key process step in the manufacturing of prefilled syringe systems.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

Gelest, a manufacturer and provider of silane, silicone, and metal-organic compounds, released a range of dual-function poly(ethylene glycol) (PEG) reagents that enable new approaches to PEGylation for bioconjugates.

There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.

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.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

The authors review methods for generating monoclonal antibodies for research and development.

A case study demonstrates that affinity chromatography can offer efficiency and scalability for gene therapy manufacturing using viral vectors.

Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.

This review examines how microfluidics has been used in the formulation, preclinical, and clinical development of gene-delivery nanoparticles.

Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.