BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support your commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face. Experience Makes the Difference: With 80 years of parenteral expertise, we can help to navigate the pathway of success for your molecule. As a dedicated CMO with over 20 years of experience devoted to our customers’ clinical and commercial success,…

Peptones have a long history of use in cell culture media. However, increasing emphasis has been placed on growing cells in animal-free and chemically defined systems for the production of biopharmaceuticals. This has created a demand for cell culture media supplements that equal the performance of peptones but have greater certainty of composition. This demand prompted BD’s efforts to identify the functional components of yeast extract to develop a chemically defined supplement, BD recharge. Formulation The keys to making a…

It is important to ensure that testing services meet applicable regulatory standards necessary to support investigational new drug (IND) applications, the clinical development life cycle, and commercialization. However, monitoring and — when possible — anticipating the ever-changing regulatory landscape is a challenge. Yet, the failure to do so can negatively affect both the cost and time needed to move a product from development through to commercialization. This article describes BioReliance’s position concerning anticipated regulatory changes over the next three to…

Both industrial and research scale protein purification require the development of superior procedures for increasing recovery yields. This places an emphasis on maintaining proteins in fully reduced states to solubilize inclusion bodies, while increasing the recovery of active proteins through improved protein-folding technologies. These concerns have a common theme: the ability to maintain the disulfide bonds in the protein in a sufficiently reduced state so as to facilitate correct folding while simultaneously avoiding protein aggregate formation. Dithiothreitol (DTT) is still…

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…

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…

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…

          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…

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…

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…