Development

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

Miniature bioreactors add value by reducing validation efforts.

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

ViaCyte and Janssen Biotech have entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.

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.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

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.

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

The company plans to reformulate injectable products to make them into inhaled and intranasal medications.

Use of a subspace model is a viable method to characterize process space variables and optimize process performance.

Paras Biopharmaceuticals and Novozymes will collaborate on the creation of an improved osteoporosis treatment.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

A new consortium involving Arecor, FUJIFILM Diosynth Biotechnologies and the Center for Process Innovation will focus on formulation innovation as a way to improve downstream processing and reduce biopharmaceutical cost.

The global supply chain for bovine and porcine heparin and regulatory considerations are examined.

The novel antibody-engineering platform works differently than most of the currently employed antibody-modifying technologies, according to UM Baltimore.

The company presented a portfolio of new products during the meeting in Madrid.

Can alternative approaches to the permitted/acceptable daily exposure be justified?

This article introduces the technology that powers automated HT–DLS and explores its practical applications in enhancing formulation stability investigations.

Rafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a