Manufacturing

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.

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

The authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Kevin Ott, executive director of the Bio-Process Systems Alliance, discusses the latest trends and issues surrounding single-use technologies and the role of his association.

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

FDA has released a list of more than 50 guidance documents planned for 2013.

FDA has released a list of more than 50 guidance documents planned for 2013.

NIBRT's Michael Lacey provides an overview of biopharmaceutical facility design and operation.

A look at vaccine history, markets, manufacturing, and overcoming the scale-up dilemma.

Improvement strategy should be linked to business strategy.