2012

A Host Cell Protein Assay for Biologics Expressed in Plants

    Host cell proteins (HCPs) can be present in significant amounts in biological products through copurification with a recombinant protein-drug substance. Purified active ingredients developed for human use must be free of all contaminants — including residual HCPs — to minimize the incidence of immunogenicity against a drug product or its trace contaminants (1).   HCP assays allow for monitoring host-related impurities during product development and process development. Most are in the enzyme-linked immunosorbent assay (ELISA) format for detecting…

Integrity Testing of Ultrafiltration Systems for Biopharmaceutical Applications

    Ultrafiltration (UF) is a membrane-based separation technology commonly used in the biopharmaceutical industry for concentration or diafiltration of protein solutions to remove low–molecular-weight (LMW) impurities or exchange buffers. The nominal MW limit of UF membranes ranges from 1,000 Da (1 kDa) to 1,000,000 Da (1,000 kDa). A target product is retained by the membrane while lower-MW solutes or impurities pass through (1). For a target product with a smaller MW than the impurities, separation is accomplished by allowing…

Enhancing Data Quality with a Partly Controllable System at Shake Flask Scale

    In bioprocess development, small-scale systems are used to identify appropriate cell lines, media, and feeds before applying more expensive, controlled cultivation systems at larger scales. Process development relies on data generated in such uncontrolled small-scale cultivation systems, so comparability is an issue. Shake flasks are commonly used for small-scale culture of mammalian suspensions. Incubators provide a suitable environment with carbon dioxide (CO2) supply and humidity control and ensure sufficient oxygen transfer and homogenization of cell suspension by appropriate…

Global Marketplace

3D Bioreactor Product: InBreath whole-organ bioreactor Applications: Tissue engineering and regenerative medicine for trachea, esophagus, intestines, blood vessels, and other hollow, tubular organs Features: The autoclavable, GLP-compatible InBreath bioreactor is designed for cell seeding and culturing on intraluminal and extraluminal surfaces of a tubular matrix. A polymer culture chamber houses the scaffold and culture medium for the entire duration of organ generation. Secondary “paddle” elements move with the scaffold holder to mix the culture medium continuously for mass transport and…

IBC’s Inaugural Drug Product Quality Summit

The vast majority of drug shortages — 82% of the 168 products in short supply — are sterile injectables. According to an IMS Institute for Healthcare Informatics report from November 2011, many are linked to fill– finish deficiencies. In addition to supply shortages, medicines can be delayed in reaching patients due to contaminated raw materials, findings of particulates, extractables and leachables, vial stopper and glass problems or interactions with product, and even cross contamination. IBC’s Drug Product Quality Summit is…

Listening to Patients’ Voices

    The role of patients in changing the pharmaceutical industry’s research agenda is evolving. Patients are greatly affected by drug R&D, with its potential to provide cures or treatments for a wide range of different medical conditions. But new product development does not always meet all patients’ needs. For example, drugs for Parkinson’s disease most often aim to treat movement disorders, whereas patients are also concerned about pain, sleep problems, lack of bowel and bladder control, and sexual dysfunction…

Thermo Fisher Hosts a Series of BioProcessing Seminars

Thermo Fisher Scientific wrapped up its North American series of BioProcessing Technology Seminars in June 2012 in North Carolina. Over two months, the company and local biomanufacturers hosted six all-day events at different venues focusing on cell culture media design, single-use systems, bioreactor technologies, and performance optimization. Agendas included interactive presentations from industry experts and typically ended with a tour of a local bioprocessing facility. On 21 June in Cambridge, MA, Eric Langer (BioPlan Associates) kicked off the fifth meeting…

Global Marketplace

  Product Development   Service: Contract development and manufacturing Applications: Clinical- and commercial-scale complex biologics Features: Therapure Biopharma specializes in biologics development, scale-up, and manufacturing. At its 130,000-ft2 CGMP facility in Toronto, Ontario, Canada, the company offers cell-line, process, and analytical development; product manufacturing and testing; and aseptic fill–finish and lyophilization. It has >20 years of experience working with mammalian and primary cell cultures, whole blood, and plasma sources. Contact Therapure Biopharma www.therapurebio.com     Capsule Filters   Product: CM…

Agenda-at-a-Glance

    For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012, The BPI Conference and Exhibition returns to Providence, RI and the Rhode Island Convention Center ()   For 2012,…

BioProcess International Conference and Exhibition

Expand your knowledge with unparalleled access to new, unpublished data and exclusive case studies from companies of all sizes and perspectives at the most comprehensive event for those directly involved with improving the speed, cost, and quality of developing and manufacturing biotherapeutics. This event will help you improve manufacturing and development efficiency, enhance process understanding and quality, advance cell culture and upstream processing, streamline recovery and purification, and optimize the quality and novelty of your next-generation biologic drug products. To…