Drug Development

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

Choosing the right container and container closure system is crucial for ensuring product quality, safety, and efficacy of a biologic formulation.

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

Thermo Scientific TruTools chemometrics package extends the capabilities of the portable TruScan RM Raman Analyzer.

The author discusses key process parameters and shows how a process optimization template can be used to improve this key operation.

The author discusses issues and best approaches for solid dosage form pharmaceuticals.

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

This article explores two commercial platforms, and touches on a new program underway in the UK.

Stephen Hoag, a professor at the University of Maryland (Baltimore), and a member of the National Institute of Pharmaceutical Technology and Education (NIPTE) offers a brief update on issues, and NIPTE’s database project.

Matt Richardson of Capsugel and Michael Morgen of Bend Research, discuss improvements and results that have been seen in the second generation of hydroxypropyl methyl cellulose (HPMC) materials.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

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

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

Analytical laboratory equipment adapts for new realities of downsizing, outsourcing, and speed demands.

Hazardous reagents can prove to be faster, simpler, cheaper, and greener.

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.

As specialty API outsourcing grows, manufacturers and contract development and manufacturing organizations are investing for the long haul.

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.