Contract manufacturing of biologics is more than having superior technology — it’s having experienced people who are passionate, responsive, and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organization (CDMO), Therapure Biomanufacturing has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical, and commercial). Our 130,000-ft2 (12,000-m2) CGMP manufacturing facility meets FDA, EMA, and HPFB regulatory standards and includes flexible clinical and…

Vetter, a leading provider of aseptically prefilled drug-delivery systems, operates a state-of-the-art facility at the Illinois Science + Technology Park in suburban Chicago, IL. The site offers a central US location with a domestic and international airline hub. It is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure and prominent research institutions. The company’s Chicago site supports preclinical through phase 2 development projects. The 27,000-ft2 facility’s functional areas include microbiology and chemical analysis laboratories; materials preparation;…

Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with over 20 years of experience in microbial systems. Our customers benefit from a comprehensive service for the development of robust and highly efficient production processes and GMP-compliant manufacturing for clinical trials and commercial supply. Service Wacker Biotech’s services cover the whole process chain: from construction and optimization of host/vector systems to delivery of the bulk API. A well-equipped quality control department supports characterization of master and working cell banks and…

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing of biotherapeutics. Biopharmaceutical companies have enthusiastically adopted Pall ForteBio’s Octet systems due to their broad utility in protein quantitation and functional characterization combined with no need for labels, real-time monitoring, enhanced throughput, decreased sample preparation requirements, and low cost of operation. Concentration Measurement The Octet platform uses ForteBio’s proprietary Biolayer Interferometry (BLI) technology to measure concentration in 96-well and 384-well…

As the pharmaceutical industry continues to accelerate its focus on developing biological drugs derived using cell culture processes, the ability to accurately monitor osmolality throughout each phase of development, production, and finished product quality control (QC) becomes increasingly important. Osmolality is arguably one of the most important physical parameters to monitor in mammalian cell cultures because of its fundamental implications to the growth, viability, yield, and the close relationship between cells and media. Freezing point osmometers are considered the gold-standard…

Switching to single-use systems can have financial and performance benefits. However, one critical challenge for complete acceptance of single-use systems is assurance of bag integrity — and in turn, product sterility and operator safety. The main risk with single-use technology is associated with leaks that can be induced by transport and handling (1). The second greatest concern regarding the use of disposables is bag breakage and related loss of production materials (2). Limitations of Pressure-Decay Testing Pressure decay is the…

Host-cell protein (HCP) analysis is a big issue when it comes to early clinical testing, design of downstream processes, and quality control of biopharmaceuticals. The decision to use an off-the-shelf generic HCP assay or spend a considerable amount of money for development of a specific HCP assay is often not an easy one. In theory, generic HCP assays should be suitable for all HCP determinations of a specific cell line — independent of cell line modifications, fermentation conditions, and the…

Flexibility has been the key driving force behind the success and growth of Eurofins Lancaster Laboratories’ viral clearance program. “When we introduced four levels of service solutions for viral clearance studies, our clients responded well,” says Dr. Kate Bergmann, manager of viral safety and clearance. “They appreciate that we can tailor our program to meet their specific needs. They can use any of our service levels to address all their scientific, safety and scheduling challenges.” To provide additional capacity, the…

The ultimate objective in the development of any new therapeutic candidate is the validation of its mechanism of action and therapeutic efficacy in a clinical setting. Three important areas of product development are critical in determining the success of a new drug candidate: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical and initial stages of clinical development fundamentally resides in problems with manufacturing, stability, or safety issues. A Potential Risk for Everyone: The Cost…