August 2013

The RAMbio Incubator Improves Culture Growth and Protein Expression

End oxygen limitations when growing Escherichia coli, Streptomyces, Pichia, Aspergillus, and other high-demand aerobes in shake flasks. Many bioprocesses rely on aerobic growth and protein expression, yet traditional orbital shakers do not provide adequate oxygen. Cultures become oxygen limited. The RAMbio incubator solves this problem by providing active headspace refreshment using low-frequency acoustic energy that aerates standard shake flasks. Why Use the RAMbio? The increased dissolved oxygen provided by the RAMbio may benefit aerobic microbial cultures by Increasing biomass, protein,…

Polishing a Monoclonal Antibody (MAb) Using Capto™ adhere ImpRes in Bind and Elute Mode

A platform approach for MAb purification is desirable as it saves both time and money in process development. GE Healthcare Life Sciences’ MAb toolbox employs protein A chromatography media (resins) as well as a wide range of options for polishing purification steps. One of these options is Capto adhere ImpRes, a cost-effective and flexible multimodal anion exchange chromatography medium designed for high-resolution polishing of MAbs. The medium allows operation in either bind-elute (B/E) or flow-through (FT) modes. Here we describe…

Scale-Up of Human Mesenchymal Stem Cells on Microcarriers in Suspension in Single-Use Bioreactors

Mesenchymal stem cells (MSCs) are an attractive target for clinical study as therapeutic agents. However, current multilayer flatbed culture-expansion paradigms are cumbersome, time consuming, and typically limited in the ability to monitor cell characteristics during the growth process. We have used the Mobius® CellReady 3-L bioreactor in combination with microcarriers and human mesenchymal stem cells (hMSC) as a model. Following expansion, we have comprehensively compared the characteristics of cells grown in the bioreactor with those grown in standard two-dimensional (2D)…

4 New Viral Clearance Suites, 4 Service Models, All 4 You

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…

Biopharmaceutical Product Development

Catalent is your strategic partner for biologic drug development success. We create smart, tailored solutions with our novel SMARTag™ antibody–drug conjugation (ADC) technology, our market-leading GPEx® cell line expression system, expanded biomanufacturing capabilities, and integrated development services to help you get better products to market faster. New SMARTag ADC Technology for Development of Optimized Antibody–Drug Conjugates — Superior Technology for Treatments in Development: Catalent has entered into an exclusive license and comarketing agreement with Redwood Bioscience to offer customers SMARTag…

Downstream Scale-Up Purification of Influenza Virus Using ReadyToProcess™ Equipment

The vaccine manufacturing industry is continuously seeking more flexible and time-saving solutions for a quicker response to pandemic outbreaks (1, 2). For influenza, vaccine is traditionally produced in fertilized hen eggs and purified in fixed steel equipment. Here we describe the scale-up of a downstream purification process of cell-based influenza virus, from a 10 L cell culture to the purification from a 50 L culture using ReadyToProcess single-use technology. Single-use technology reduces the need for time-consuming device preparations, such as…

Georgia, USA

Georgia’s strong and growing fill and finish sector includes access to an extremely talented workforce and world-class global infrastructure for cold chain, logistics and transportation. World-Class Distribution and Logistics Infrastructure Cold-Chain Storage in Georgia 70 cold-chain facilities 90% of the top 25 global third-party logistics providers (3PLs) Operations for four of the top five global public refrigerated warehousing companies Four major US interstates enabling companies to reach 80% of the US market by truck in less than two days Georgia…

Designing Quality into the Product

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…

Validation of the New Single-Use Freeze-Pak™STS

Figure 1:  Production of biologics — whether for clinical development or large-scale manufacturing campaigns intended to be converted to final drug product — often involves frozen storage. It provides manufacturing process flexibility while enabling long-term product stability. Products are frozen and stored using a number of technologies: stainless-steel vessels, bottles, carboys, and disposable bags. Although single-use freezing bags are a common choice for storing biologics, challenges with durability persist. Single-use bags intended for freezing and storage are often made with…

EcoPrime

Table 1:&#8 LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPLC, SMB, and LPLC chromatography worldwide. A customer came to us several years ago requesting a low-pressure liquid chromatography system with a flow range of 20–2,200 L/h. They also wanted the ability to achieve linear gradient from 1 to 99%. We designed and…