Monday, August 1, 2011 Daily Archives

Protein Crystallization in Downstream Processes

Two decades of intensive development of novel expression systems for mammalian cells and microorganisms have led to a significant increase in fermentation titers in the biopharmaceutical production of proteins (more than 20 g/L in microbials and more than 4 g/L in mammalian cell culture). However, dynamic binding capacity of chromatography resins is often limited, and very large chromatography columns are needed to purify such large amounts of target proteins. New paths for cost-efficient purification are therefore needed, including downstream processing…

Increase Efficiency and Accelerate Protein Workflows with the LabChip GXII

Vaccine engineering, antibody quality screening, and glycosylation profiling processes can generate large quantities of protein samples that must be analyzed in a timely manner. Generation of high-quality data and rapid, quantitative analyses are mandatory to determine next steps. Although still heavily relied upon, sodium dodecyle sulfate polyacrylamide gel electrophoresis (SDS-PAGE) is labor-intensive and only semiquantitative, and its throughput capacity is limited. Quantitative analysis techniques such as capillary electrophoresis (CE) and high-performance liquid chromatography (HPLC) do not provide the throughput necessary…

Cryogenic Storage of Human Hematopoietic Progenitor Cells

Successful cryopreservation of hematopoietic progenitor cells (HPC) depends on a number of factors: biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation, and transfer of hematopoietic progenitor stem cells (HPCs). These bags are made from a unique polyolefin film that offers excellent durability while remaining flexible when stored at ultralow temperatures (−196°C). Their proprietary membrane port design offers thinner walls for increased flexibility, and an industry-standard label…

Rapid Cell Line Development with Integrated Protein Analysis

          The standard cell line development pathway at many contract service organizations is based solely on selecting clones by growth and productivity with little or no analytical characterization of the expressed protein. The use of protein analytics to support selection of clones that match desired product quality is important for second-generation processes and will be of utmost importance for biosimilar development. CMC Biologics performs sophisticated protein characterization using state-of-the-art analytical equipment combined with our robust cell…

All-in-One Sterile Connect and Disconnect Option Expands Manufacturers’ Flexibility

As single-use systems (SUS) continue to be incorporated throughout bioprocess manufacturing, a wider range of solutions and flexibility is being requested of the connections currently used in single-use systems. Colder Products Company, the leader in single-use connection technology, has been listening to the trends in the marketplace and has responded by expanding its product offering to incorporate a wider range of connections options for the single-use market. AseptiQuik® DC is the first all-in-one sterile connection technology to offer both a…

Bioprocess Scale-Up Using Corning® HYPERStack™ Vessels

In the development of a new biological product, it is important to remember that a successful R&D development project needs to be converted from a bench-scale concept to a bioproduction platform. This process development stage requires identifying ways to increase cell numbers to meet annual dosage demands, as well as to minimize direct contact with the cell product by developing a closed system for all culture manipulations. identifying a bench-scale platform that can scale to CGMP production scale eases the…

Comprehensive Global Capabilities and Extensive Scientific Expertise

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its comprehensive portfolio of services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. Working with clients of all sizes, Covance recognizes that your development program is as unique as the product you bring to our facilities. With >250 different biomolecules successfully supported annually, Covance Biotechnology Services provide you…

Rhobust® Technology

Product recovery is a lengthy and costly procedure consisting of centrifugation and depth filtration steps to remove the cells (clarification), followed by multiple cycles of packed-bed chromatography that bind and separate the target molecule from cell culture medium components (capture). The Rhobust® Technology is a second generation expanded-bed adsorption (EBA) technology that provides an elegant solution to using multiple process steps by combining clarification and product capture into one single step in the first downstream process unit operation. The Rhobust®…

XD® Technology

DSM Biologics has developed a highly intensified cell culture process termed XD®, which provides cells with a constant environment for optimal cell growth (Figure 1). The XD® Technology works in a continuous media feeding mode with a filtration unit to retain both the cells and the recombinant protein in the bioreactor. Compared with a standard fed-batch process, the feeding regime in the XD® process can be performed with basal media, and this allows straightforward implementation without the need for extensive…

Formulation and Fill for a Vaccine with Alum Adjuvant

The goal: Develop a CGMP formulation–fill process for a subunit vaccine–aluminum adjuvant complex. The challenge: To engineer a scaled-up process for vaccine–adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product. The Outcome: Florida Biologix scientists successfully developed the manufacturing, formulation–fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to the clinic on time. About…