Manufacturing

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

This marks the first time a biologic manufactured in China has been released for use in a clinical trial in Europe.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Experts in the field share some best practices for optimizing process economics in biomanufacturing.

The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.

The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.

Collaborative efforts are underway between suppliers and drug manufacturers to address raw material variability.

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.

Microbial models offer some exciting production alternatives.

Miniature bioreactors add value by reducing validation efforts.

The authors provide their perspectives on shipping validation.

Researchers discovered more than 300 antibodies that reacted with the Ebola virus’s surface glycoprotein and could be used to neutralize many strains of the virus.

FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

The agency prepares a plan to implement new packaging safety features.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.

Rapid methods to test CAR-T therapies for potential contamination are on the horizon.

The authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.