April 2009

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…

Trends in Single-Use Bioproduction

    Most people in the biopharmaceutical industry recognize, at least anecdotally, that the use of disposables in biomanufacturing is moving forward. At BioPlan Associates, we’ve tried to quantify how things are advancing and capture some of the shifts in attitudes, especially in light of current economic challenges. The major shift is that decisions are being made more from an operational point of view. It’s become less a question of if disposables will be implemented than of where and how.…

Environmental Life-Cycle Assessment of Disposable Bioreactors

    Disposable technology for bioprocessing is efficient and cost effective in many product development scenarios. For an industry dedicated to improving human health, however, the environmental contributions of a product must also influence its bottom line. Product transitions evaluated within a people/planet/profit framework require assessment regarding shifts in human and environmental impact. Life-cycle assessment (LCA) offers one perspective by evaluating the environmental loading of inputs and outputs to a product or process. The contribution of individual product life-cycle stages…

21st Century Vaccine Manufacturing

Establishment of standard production platforms can help vaccine development move a step closer to the commercial, technical, and regulatory benefits increasingly enjoyed by developers of monoclonal antibody (MAb) products. Three recent advances especially will assist vaccine manufacturing development: rapid analytical methods to support evaluation of process design and provide in-process control; and the establishment of supply chains and vendors across Asia for bioprocessing equipment and consumables that meet the highest international standards. Whereas some workers in the field may consider…

Scaling Up a CHO-Produced Hormone–Protein Fusion Product

    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…

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…