Manufacturing

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

An integrated focus on product design, development, operation, and control.

Quality control for disposable-bags

Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.

Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Mani Krishnan, director of systems at EMD Millipore live at Interphex 2013 about single-use technology. In this interview they discuss areas of growth in single-use technology as well as reservations that some companies have to switching to single-use systems Krishnan identifies a few technology advances that are overcoming these objections as well as decision-making strategies for facilities considering a switch to a single-use system.

Editorial Director Rita Peters interviews Alan Fisher of Dycem about risk management is applied to contamination control for pharmaceutical manufacturing

Project will optimize expansion and harvest of human cells in bioreactors.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

The author discusses issues related to the supply of soft parts in the biopharma industry.

BioPharm International spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.

Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.

BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation.

Third compounding pharmacy recalls products due to FDA inspection.

Unique technology expands Entegris? fluid-sensing and control offering.

Catalent Pharma Solutions has acquired a license to market Redwood Bioscience 's proprietary SMARTag precision protein-chemical engineering technology.

Astellas and Ambrx have entered into a collaboration to discover and develop novel antibody drug conjugates (ADCs) for an undisclosed number of targets in oncology. ADCs enable targeted delivery of drugs to the target tissue.

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Review the process-design space and scalability of a single-use, stirred-tank bioreactor.

Jerold Martin considers the types of tubing available to the industry and how to make an informed selection.

Reduced carryover risk and close attention to particulate control result in greater patient safety through the use of single-use systems.

BioPlan's Annual Report shows continued growth in the use of single-use technology.

The authors suggest techniques for mitigating risk and securing the supply chain for single-use components used in biopharmaceutical manufacturing.

The move to single-use manufacturing has prompted a paradigm shift in facility design.

Benchmarking can be a useful tool to improve manufacturing practices.

The authors describe the growth characteristics of human mesenchymal stem cells cultured in a stirred-tank bioreactor.

INTERPOL and 29 of the world's largest pharmaceutical companies have joined forces in an initiative to battle counterfeit drugs.

A Q&A with SAFC and BioReliance about sourcing and risk mitigation for raw materials.

Optimized freeze-drying cycles can offer scientific and business advantages.

Aggregate formation is influenced by multiple aspects of the bioproduction process but can be mitigated by good process design and control.