Manufacturing

Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?

Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

Cryopak’s CryoCube reusable temperature-controlled shipping systems are available in several insulation categories, and a tailored solution can be modeled using thermal modeling software.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

CMOs must embrace flexibility in their technology decisions and business arrangements.

Eric Jayjock, Patheon’s director of continuous manufacturing, discusses the CDMO’s plans for its new continuous manufacturing business.

Successful development requires coordinating and aligning drug and device design, focusing on a complete drug delivery system that meets patients’ needs.

TraceLink’s Graham Clark, director of contract supplier relationships and cofounder, and Brian Daleiden, vice-president of industry marketing, shared insights into industry’s serialization readiness as well as recent trends and developments with Pharmaceutical Technology.

Advanced digital ledger technologies offer potential solutions, but are still several years away from practical use.

The contract development and manufacturing organization (CDMO) Aesica Pharmaceuticals has had a serialization program in place for the past five years, and recently installed capabilities for serialization at all its packaging facilities.

Elevating the project management function can improve transparency and enable companies to react faster to internal and external change.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.

Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).

A sampling of new laboratory equipment showcases streamlined operations.

Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

ipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

JLL ranks top 10 US life-sciences locations where scientists prefer to work and finds that location and workplace culture are key priorities.

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.