In BPI’s June issue, we presented a supplement on geographical trends in biomanufacturing. We looked at the influence of a growing demand for biotherapeutics in emerging countries and the influence of new technologies that are driving interest in smaller, perhaps more geographically distributed production. We wanted to explore what a global bioeconomy would look like and where its primary capacity would be concentrated. Authors provided examples of how to balance cost with control issues. They talked about working in different…
2010
Poster Presentations
Product Lifecycle Management Jayne Hesley, applications scientist in marketing for Molecular Devices, Inc. (Sunnyvale, CA) Homogeneous Antibody Binding Assay: Comparing Imaging Systems and Optimizing Acquisition Parameters for High-Throughput Screening Hybridoma cell lines are cultured to produce monoclonal antibodies for use in diagnostics, vaccine development, or therapeutics. One well-accepted assay for screening the antibody-containing supernatant of hybridomas is to capture the antibody on the surface of beads (
Sequence Variant Analysis Using Peptide Mapping By LC–MS/MS
Monoclonal antibodies are usually expressed in mammalian cell lines and are produced in several variants known as isoforms (1,–2). Microheterogeneity can result from posttranslational and enzymatic modifications as well as those caused by processing, alteration, storage, and incorrect translation of the target protein (1,3). Common sources of heterogeneity include Fc glycosylation, partial carboxypeptidase processing of heavy-chain (HC) C-terminal lysine residues (4), deamidation or isomerization (5), Fc methionine oxidation, hinge-region fragmentation (6), aggregation, and sequence variants. Sequence variants are…
Minimizing the Environmental Footprint of Bioprocesses
Biomanufacturers must take active measures to minimize their environmental footprints and promote environmental sustainability. The collateral benefit of reducing environmental footprint often is viewed as only a secondary consideration after cost of goods and product quality. Biopharmaceutical processes are 80% defined by the time of proof-of-concept studies (clinical trial stage 2b). This milestone is before the official technical transfer to commercialization or manufacturing organizations and almost always before the environmental evaluation of a production process. This step is…
Demonstrated Performance of a Disposable Bioreactor with an Anchorage-Dependent Cell Line
Increased adoption of disposable storage vessels and mixing systems for biopharmaceutical manufacturing operations has provided economic and efficiency benefits to a number of life-science companies. Single-use technologies have reduced validation requirements, shortened turnaround times, eliminated cleaning regimes, increased the speed of set-up procedures, and facilitated the development of flexible manufacturing platforms. Many biomanufacturers have sought to extend those benefits into the field of cell culture by using disposable bioreactors. Here we describe work undertaken to develop and demonstrate…
IBC’s 14th Annual Well Characterized Biologicals Practical Case Studies, Analytical Strategies, and Regulatory Perspectives for Protein Product Characterization
IBC’s Well Characterized Biologicals conference is the top forum for hearing industry case studies and unpublished new data on the challenges, strategies, and technologies involved in protein characterization. Register now for exclusive access to meet FDA reviewers and industry experts who will share their insights to help you implement new approaches and avoid common pitfalls in your own characterization projects. Hear first-hand from FDA reviewers about their “pet peeves” and suggestions to help you improve your IND packages and characterization…
Global Marketplace
Single-Use Bioreactors Product: Modular, integrated bioreactors Applications: Single-use cell culture Features: PBS Biotech has introduced its “next-generation†single-use bioreactors. The first three models support maximum working volumes of 3 L, 15 L, and 80 L to support expansion and process scale-up from R&D to pilot plants. The modular, preconfigured bioreactors feature an integrated controller with a graphical user interface, proprietary low–shear-stress Air-Wheel agitation, automated sampling, and an on-board database. Each unit is built to order,…
Manufacturing Convergence Technologies
Many regenerative medicine products represent a convergence of pharmaceutical, biologic, and medical device technologies. Although such products could have a great impact on medicine, they often pose significant challenges for their developers, requiring companies to incorporate competencies from several technology sectors. By addressing commercial regulatory and manufacturing challenges at an early stage in product development, these companies are more likely to succeed in reaching their commercial goals. Exact regulations governing the manufacture of a convergent technology — or…
Novozymes Biopharma
With over 45 years’ experience in microbial protein expression, we deliver animal-free, recombinant biological products and technologies to forward-thinking medical device, drug formulation, and drug delivery manufacturers. Working closely together with our customers, we can provide customized biological solutions to make their products safer and more effective while getting them to market faster and hassle free. Recombinant Human Albumin (rHA) A range of rHAs (Recombumin®, albucult®, CellPrimeâ„¢ rAlbumin AF-S) developed for industrial cell…
Your Partner for High-Quality Protein Hydrolysates
FrieslandCampina Domo, a division of the Ingredients Business Group of Royal FrieslandCampina BV, is one of the operating companies formed as a result of the merger between Friesland Foods and Campina in January 2009 to form Royal FrieslandCampina. Royal FrieslandCampina is a leading global multinational company, with 22,000 employees and revenues of over 9 billion Euros. Formerly Known As DMV International The operating company FrieslandCampina Domo incorporates parts of the companies formerly known as DMV International Nutritionals and Friesland Foods…