February 2009

Non-Invasive Sensors as Enablers of “Smart” Disposables

    Disposable bioprocessing has come of age. Economic and regulatory conditions are driving the widespread adoption of disposable equipment at all stages of bioprocessing. This review considers the entire bioprocess chain and assesses the status of disposables. In particular, we focus on the current availability and need for additional sensors that will enable the disposable process to be integrated — in compliance — with the latest Process Analytical Technologies. Traditional bioprocessing is highly compartmentalized into upstream and downstream operations.…

The Maturation of the Biomanufacturing Industry

    In my opening editorial, I referred to an industry in transition. This is being driven by challenges that are by no means unique to biotech: all other industry sectors are experiencing similar pressures. We are seeing the impact in terms of factory design, manufacturing technologies, validation and business processes; these are all themes that have been addressed in this supplement. The big innovation in terms of manufacturing systems has been the wholesale acceptance of disposable manufacturing technologies during…

MAb Contaminant Removal with a Multimodal Anion Exchanger

Monoclonal antibodies (MAbs) constitute ∼30% of the biopharmaceutical products currently under development (1). An increasing demand for MAbs during the past decade has led to intense development of high-expression cell cultures (2). Today, it is possible to see titers of 4–5 g/L, and expression levels as high as 15 g/L and greater have been reported. As a consequence, demand has increased for more efficient downstream processes. That demand, combined with its potential for reducing time-to-market, has increased interest in the…

Better Positioned Than Ever

    In June 2007, Sartorius AG acquired the French company, Stedim S.A., and a global solution provider for the biopharmaceutical industry was created. Since then, the new company — Sartorius Stedim Biotech (SSB) — has entered into collaborations with a number of other key industry players, including Metroglas, Bayer Technology Services GmbH and the recently acquired Wave Biotech AG to bring technologies such as single-use bioreactors, UVC irradiation and the first disposable–integrated electrochemical pH sensor into its rapidly expanding…

IBC’s 18th InternationalBiological Assay Development and Valiation

Biological assays continue to be considered the “quality” assay for biopharmaceuticals. Companies often ignore their importance and find themselves on clinical hold in phase 2 — or worse, in phase 3 — because their biological assays do not meet current expectations. (Usually there are performance, robustness, and/or specificity problems.) This is the conference to find out the newest technical, regulatory, and practical trends for the all-important biological assays. IBC’s 18th International Bioassay meeting has it all. Get the tools you…

Disposable pH Sensors

    This paper describes the design, development and validation procedure for a novel, single-use gamma-stable electrochemical pH probe jointly developed by Sartorius Stedim Biotech SA and Metroglas. This new, single-use pH sensor offers a range of pH measurements (from 0 to 11 with ±0.1 precision) and features a one-point calibration process in its storage solution that provides a fast and easy pre- and post-use sensor performance check. Also described is a specific encapsulation device designed to integrate the pH…

Global Marketplace

  Disposable Clamps     Product: 6″ and 8″ BioClamps Applications: Biomanufacturing Features: In addition to the 0.5″ to 4″ family range of disposable BioClamp products, BioPure Technology now offers 6″ and 8″ sizes. They meet the requirements of media transportation for light weight, strength, and easy manipulation. Two wing-nuts provide even compression across the entire circumference for a secure and safe seal, with the added benefit of perforation to facilitate tamper-proof ties. Underside-molded lot numbers ease traceability, and clamps…

Implementing Gamma-Stable RFID Tags in Single-Use Fluid Management Systems

    This paper describes how RFID (Radio Frequency Identification) technologies can be implemented into single-use systems to generate electronic records for both bag manufacturers and bag end-users. RFID technology will enable the user to both read and write all relevant product and process information directly onto the single-use bag, providing instantaneous data recall. The tag can also provide the user with immediate access to the bag’s original part number, lot number, date of manufacture, expiration date and other critical…

Developing Best Practices for Disposables

The current lack of best practices for implementing single-use manufacturing technologies in pharmaceutical and biopharmaceutical manufacturing is a recognized challenge in the industry. At the 2008 BioProcess International Conference and Exhibition in Anaheim there was a lively debate from end users perspectives, “Developing Best Practices for Disposables.” This discussion identified the work that various industry associations are doing in this area, outlined here. The Bioprocess Systems Alliance (BPSA www.bpsalliance.org) plastics trade organization has developed a series of guidelines relating to…

An Industry in Transition

As an industry, biopharmaceutical manufacturing is in transition and is facing challenges borne out of success. It was in the early 1980s that the first products were commercialized, namely the replacement hormones insulin and human growth hormone. The industry initially grew rapidly in the early ‘80s against a background of an immature supply industry: there were no large-scale columns (>10 cm diameter), column controllers, limited resin supplies and no established ultrafiltration technology. The position today is that the industry has…