Many biotechnology companies recognize the powerful benefits of increasing product titer early in product development as a strategy to minimize manufacturing costs, scale, and the duration necessary to produce clinical supplies and achieve product commercialization. Additional benefits include minimizing or completely avoiding significant regulatory delays to market that can be caused by major process technology changes (such as cell line and product quality changes). Recently, another significant benefit has been realized too: Smaller, more productive and efficient 2,000-L…
2009
Assay Validation for Rapid Detection of Mycoplasma Contamination
Mycoplasmas and related bacteria in the class Mollicutes are parasitic organisms found not only on the external surfaces of a wide range of eukaryotic host cells, but also intracellularly. They are characterized by small size and lack of a rigid cell wall, which gives them resistance to β-lactam antibiotics and the ability to pass through 0.2-µm filters (1,2). Contamination by Mollicutes is a common problem for cell cultures that is not easily detected because it usually does not produce turbidity…
Bridging the Gap from Reusable to Single-Use Manufacturing with Stirred, Single-Use Bioreactors
During the past few years, use of disposable bioreactors in development and manufacturing processes has become widely accepted. Particularly, low–oxygen-demanding cell types such as human and insect cells have proven to be perfectly suitable for cultivation in single-use bag chambers. These bioreactors have significant advantages over their reusable counterparts (1). They transform a single-purpose process using stainless steel reactors into a multipurpose facility in which switching from one application to another is both easy and cost effective. Reusable…
Real-Time Bioreactor Monitoring of Osmolality and pH Using Near-Infrared Spectroscopy
Osmolality and pH are important cell culture process parameters, key elements that are often examined and optimized to improve the productivity of cell-culture–based bioprocesses. Osmolality affects cell viability and growth by regulating the transport of water and nutrients through cell membranes and pH maintains the isotonicity of a culture. To monitor these parameters in cell culture, samples are typically withdrawn and passed through a multifunction analyzer as the BioProfile 400 instrument from NOVA Biomedical (www.novabiomedical.com). Withdrawing samples during a bioreactor…
Integration Is the Future of Single-Use Technology
Single-use technologies are becoming more widely accepted by biopharmaceutical manufacturers than ever before. The market is complex, fast-growing, and dynamic, which means integrated innovative technologies are the key to keeping pace with biopharmaceutical manufacturing needs. In fact, end users are already beginning to move away from singular disposable components to increasingly require suppliers to provide integrated solutions for specific process needs. So it is critical for suppliers to work closely with their customers and provide novel solutions. Why the Switch?…
Ratiometric Photometry Improves Laboratory Quality Assurance
Laboratory scientists often assume that their liquid-handling instruments, from pipettes to automated liquid handlers, are operating within specification. But given that data integrity for applications from drug discovery to molecular diagnostics relies on accurate and precise liquid delivery, that can be a very risky assumption with high costs of failure. Those costs and risks are compounded by several trends in today’s life-science laboratories, such as the growing use of valuable reagents at low volumes and an increasingly strict regulatory environment.…
Global Marketplace
Cryopreservation Product: CryoSolve single-use CGMP cell cryopreservation media Application: Cell cryopreservation Features: These single-use syringes with Luer-lock tips help eliminate sharps, avoid cross contamination, maintain sterility, and streamline your process. Raw materials are serum-free (USP/EP) and the medium has been shown to support an average cell viability of 97%. The products are manufactured under CGMP conditions with syringes made of USP Class VI glass, compatible with DMSO. All equipment passed compatibility studies and meets the requirements of low leachables/extractables, low…
IBC’s Fourth Annual BioProcess International Analytical and Quality Summit
The fourth annual BioProcess International Analytical and Quality Summit offers a focused look at solutions and approaches to problems facing analytical scientists in product characterization, assay development, method validation and quality control. Separate conference tracks are dedicated to biophysical analysis, posttranslational modifications, and method validation — with an additional track to tie those fields to the need for improved product understanding associated with quality by design. This multitrack format allows you to customize your conference experience based on your personal…
Encyclopedia of Rapid Microbiological Methods
Many different rapid microbiological methods (RMM) have been developed in recent years, although their acceptance and implementation in the pharmaceutical industry has been slow. To stimulate the integration of RMMs in the pharmaceutical industry, the Food and Drug Administration (FDA) introduced the Process Analytical Technology (PAT) initiative in 2004. A year later, the Encyclopedia of Rapid Microbiological Methods, edited by Michael J. Miller, was published. Miller, senior research fellow in the manufacturing and science department at Eli Lily, recruited many…
The Human Network
Biotechnology is not simply about science or technology, process engineering or cell lines, corporations or regulations. It’s ultimately about the people involved in all these things — and about the people they hope to serve with their biotech aspirations. It’s about scientists and technicians, businessmen and medical professionals, patients and consumers, farmers and governments, all their lives touched in one way or another by the biotechnology industry — some admittedly more than others. Policy decisions made by…