Manufacturing

Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.

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.

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.

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.

Global outbreaks energize vaccine R&D and drive production modernization.

Pharmaceutical Technology spoke with FDA to get the agency’s insights on how the industry can ensure quality in solid and semi-solid dosage products.

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

At DCAT's annual meeting, Bill Downey, president of the market research firm High Tech Business Decisions, summarized results from its latest survey on biopharmaceutical outsourcing.

A strengths, weaknesses, opportunities, and threats analysis.

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

The Matrix Alliance was formed by Vanrx Pharmasystems with inaugural members ARaymond Life, Daikyo Seiko, Datwyler Group, Ompi, Schott AG, Schott Kaisha and SiO2 Medical Products.

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

The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.

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

The agency cited Emcure Pharmaceuticals with CGMP violations.

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

Advanced electronic batch recording (EBR) manages workflows and recordkeeping for compliance and production efficiency.

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.

The author discusses key areas of focus and presents best practices from the International Pharmaceutical Excipients Council (IPEC).

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

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

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.

Wear-resistant materials and coatings protect tablet punches and dies from abrasive formulations.

The syriQ Rigid Cap (SRC) and SCHOTT TopPac Rigid Cap (TRC) closure systems from Schott use an intuitive twist-off mechanism for ease of use and container closure integrity.

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

The module was installed in the company’s Watson laboratory information management system in Poitiers, France.

Dedusting equipment and techniques address problems associated with tablet manufacturing dust accumulation.