Manufacturing

Avid Bioservices Adds a New State-of-the-Art Biomanufacturing Facility

In July 2015, Avid Bioservices debuted its new state-of-the-art biomanufacturing facility in Tustin, CA. Designed to be one of the first US late phase 3 and commercial production facilities for the exclusive operation of single- use equipment to produce biologics, the 40,000-ft2 build-out of an industrial 110,000-ft2 warehouse provides the perfect setting to install state-of-the-art modular cleanroom bioproduction suites. This new facility incorporates the relatively recent concept of converting an existing building in to a new bioproduction facility, known as…

ThawSTAR™ Automated Cell-Thawing System: Breakthrough Adaptive Sensing Technology for Reproducible, Standardized Cell Thawing

Advances in cryopreservation techniques have been crucial for the substantial progress achieved in many fields, including cell biology research, drug discovery, bio-banking, and assisted reproduction. While cryopreservation techniques have markedly improved, downstream cell thawing techniques have thus far been neglected, even though proper thawing of cryopreserved materials is essential for optimal cell viability. The success of high-promise fields such as cellular therapy and regenerative medicine require reproducible and standardized handling of the therapeutic cells, which includes thawing both during manufacturing…

Producing Value with Boehringer Ingelheim BioXcellence™

Boehringer Ingelheim BioXcellence™ is your dedicated biopharmaceutical contract manufacturer. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience, it has brought more than 20 biopharmaceutical products to market. Boehringer Ingelheim BioXcellence™ offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria), Fremont (USA), and Shanghai (China). Boehringer Ingelheim BioXcellence™ can secure product…

Cobra Biologics Expertise, Experience, and Excellence

Expertise Cobra Biologics is a rapidly expanding international contract manufacturing organization (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three good manufacturing practice (GMP) approved facilities, each with expertise tailored to serving our customers across the world. We offer a broad range of integrated and stand- alone contract services, stretching from cell line and process development through to fill and finish for the supply of investigational medicinal products and commercial production. Read the full text of…

Application of SoloVPE to UV Concentration Measurement

FUJIFILM Diosynth Biotechnologies is implementing the newest evolution of UV-vis spectroscopy. The simple- to-use SoloVPE system provides accurate concentration measurements in under a minute, whereas comparable UV methods may take over an hour. This difference translates into less time spent on cumbersome in-process testing and more time spent confidently making product. It can measure concentration without the need for dilution, which eliminates pipetting and mixing errors associated with sample preparation. Read the full text of this application note in the…

The Effect of Rocking Rate and Angle on T-Cell Cultures Grown in Xuri™ Cell Expansion Systems

Ensuring optimal and maximal T-cell production is critical for adoptive immunotherapy and its continued success. The Xuri Cell Expansion System is an important component of the clinical manufacturing process. So we sought to investigate the effect of rocking rate and angle on the expansion of T cells. We used a combination of experimental data and predictive modeling and found that the rocking rate significantly influences the expansion potential of T cells with minimal contribution from the rocking angle. The results…

The Path to Commercial Cell Therapy Manufacturing: Developing a Strategic Roadmap

The road from conception to commercialization of a cell therapy is long, complex, and resource-intensive. To be successful, a cell therapy product must be manufactured to high quality standards using a robust, cost-effective process in a manner that will scale to meet demands and be sustainable over the commercial life of the product. Read the full text of this application note in the PDF (Login required).

High-Performance Biopharmaceutical Contract Development and Manufacturing

With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing (CDMO) of biopharmaceuticals based on mammalian cell culture. Delivering successful projects allows us to make an essential contribution to the global availability of biopharmaceuticals. Rentschler is an owner-managed company headquartered in Germany and acts independently on a long-term basis. Performing at the highest standard, we lead our clients’ projects to success according to their needs and timelines, which helps enhance their competitiveness in…

Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply

Richter-Helm is a dynamic and expanding German biotech company specialized in the development and manufacturing of products derived from microbial expression systems (bacteria and yeasts). Richter-Helm has more than 25 years of experience in process development and GMP-compliant manufacturing of recombinant proteins (e.g., cytokines, antibody fragments), plasmid DNA, and vaccines. With an experienced team of more than 150 employees, Richter-Helm offers tailored solutions to its customers with highest pharmaceutical quality standards confirmed by leading regulatory authorities (the European Medicines Agency…

Sandoz: Provider of Customized Solutions in Biotech Manufacturing

Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services, including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities. Read the full text of this application note in the PDF (Login required).