Validation Service: Confidence leachables and extractables testing Applications: Single-use equipment validation Features: Proprietary analytical techniques have been developed to detect low levels of extractables (including high-performance liquid chromatography, liquid and gas chromatography with mass spectrometry, and Fourier-transform infrared spectroscopy; testing is conducted with each test component in contact with the actual pharmaceutical formulation; other tests offered include bacterial challenge and viability testing, integrity test values analysis, and chemical compatibility testing Contact Sartorius Stedim Biotech www.sartorius-stedim.com Fermentation Product: BioFlo Pro fermentors…
January 2008
Will Diagnostics Return to Its Roots?
Diagnostic tests originated at patients’ bedsides more than 3,000 years ago. However, over the past 200 years, diagnostics moved into laboratories as the tests became more complex. Now further technological advances are bringing these tests out of the laboratory and back to a near-patient environment. This change in procedure will save both lives and money. Know Faster, Act Faster Use of diagnostic tests principally falls into three categories. The first is long-term monitoring of chronic diseases (e.g., measuring glucose levels…
20th Antibody Development and Production
IBC’s Antibody Development and Production is regarded by industry as a leading resource for process development scientists and engineers looking for the latest case studies on recent breakthroughs that help increase process efficiency and productivity. IBC has shared a unique partnership with industry experts delivering programs that present solutions to the ongoing challenges of developing and producing antibody-based therapeutics. Each year this event continues to evolve and explore new ways to accelerate speed to market and reduce cost with successful…
Process Monitoring in Suspension–Adapted CHO Cell Cultures
Suspension-adapted Chinese hamster ovary cell (CHO-S) cultures are widely used in biotechnological production of recombinant proteins. In fact, such special cell lines have become the standard for this type of biopharmaceutical production (1). The reasons for that include their fast reproduction, high protein expression rate compared with other eukaryotic cells and, above all, the glycosylation patterns generated by the cells (2, 3). PRODUCT FOCUS: Animal cell products (recombinant proteins)PROCESS FOCUS: Production and product developmentWHO SHOULD READ: Process and cell culture…
Integrated Strategies for Clone and Media Formulation Selection
Clone selection techniques used for development of stable, high-expressing recombinant cell lines suitable for robust fed-batch cell culture processes are critical for biopharmaceutical manufacturing. Basal media screening, feed development and addition strategies, and fed-batch bioreactor performance are all intimately tied to overall performance of the clones during scale-up. Serious issues can arise if a high-quality clone is not established, such as low or unstable protein yield and ineffective use of costly resources. PRODUCT FOCUS: Recombinant proteinsPROCESS FOCUS: ProductionWHO SHOULD READ:…
Comparing Shaker Flasks with a Single-Use Bioreactor for Growing Yeast Seed Cultures
Pichia pastoris is a species of methylotrophic yeast that is widely used for protein expression both in academia and the biotechnology industry. A number of properties make it suited for this task (1). Pichia has a high growth rate, and it can grow on simple, inexpensive media. It can also be grown in either shaker flasks or bioreactors, which makes it suitable for both small-and large-scale protein production. PRODUCT FOCUS: Yeast-expressed recombinant proteinsPROCESS FOCUS: ProductionWHO SHOULD READ: Manufacturing and process…
Recommendations for Extractables and Leachables Testing
Extractables and leachables from disposable manufacturing systems must be addressed as part of process validation. Extractables are compounds that can migrate from a material into a solvent under exaggerated conditions of time and temperature. Leachables are compounds that actually do migrate into a drug product formulation under normal processing conditions. All materials have extractables and potentially have leachables. When properly evaluated, both are easily addressed and rarely lead to disqualification of a disposable component. PRODUCT FOCUS: ALL BIOLOGICSPROCESS FOCUS: MANUFACTURINGWHO…
Proteomics Technology Applied to Upstream and Downstream Process Development of a Protein Vaccine
Development and manufacturing of recombinant-protein–based vaccines has in the past few years become very similar to that of other well-documented and well-characterized biological drugs. For investigational vaccines, chemistry, manufacturing, and controls (CMC) information is critical for a successful regulatory filing. The process development and CGMP manufacturing of a recombinant protein drug is on the critical path toward clinical phase 1 dosing and safety studies as well as proof-of-concept clinical studies (1, 2). However, resources invested in this process may be…
Integrating Modular Design–Build Execution Strategies into Biotech Projects
One of the earliest and most important decisions in a biopharmaceutical facility construction project is choosing a project execution strategy. This choice affects cost, schedule, and quality of the immediate project as well as further operations throughout the facility life-cycle. As technology and best practices evolve in the early 21st century, many biopharmaceutical facility projects are integrating some form of modularization execution strategy to maximize predictable costs, schedules, and quality benefits. The modularization concept can manifest as prefabricated buildings, modular…
The Biotech Boom Down Under
Australia is a key global player in biotechnology investment for the Asia-Pacific region. The environment is characterized by outstanding research facilities, accelerating employment in the industry, uniquely Australian discoveries, and burgeoning alliances between Australian and international companies. Australia’s biotech companies are rapidly maturing. The country has 427 core biotech companies that are active in human therapeutics (48% of companies), agricultural biotech (16%), and diagnostics (14%) (1). Partnerships between multinationals and Australian companies and research organizations indicate growing international appreciation of…