Drug Development

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.

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.

ICIG’s CordenPharma Group expands fermentation-based production technology with acquisition of Sandoz Site.

Ashland Chemical’s Calvert City, KY, facility is the first in the US to receive EXCiPACT certification for GMPs of pharmaceutical excipients.

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 author reviews FDA's final Animal Rule guidance.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Hazardous reagents can simplify processes and provide higher yields and purities.

The chemical distribution industry has formed an international chemical trade association to address global issues.

Choosing the right excipient manufacturer can help ensure the use of quality excipients.

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

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

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

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.

The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.

Andrew Badrot, founder and CEO of Centroflora CMS, discussed the acquisition and technical transfer of Boehringer Ingelheim’s (BI) non-captive phytochemical API portfolio with Pharmaceutical Technology.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.