BPI Contributor

January 1, 2012

3 Min Read

Disposable Bioreactor

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Product: UniVessel SU controller

Applications: R&D and process laboratory-scale cell culture

Features: UniVessel SU bioreactors work with most Sartorius Stedim BIOSTAT benchtop controllers as well as those for conventional, stirred-tank glass bioreactors. The system includes disposable SENSOLUX sensor patches for optical noninvasive pH and dissolved oxygen (DO) measurement. It is applicable to small-scale protein expression, media, and process optimization studies.

Contact Sartorius Stedim Biotech SA www.sartorius-stedim.com

GMP-Grade Nutrient

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Product: CGMP-grade hyaluronic acid

Applications: Cell culture, drug delivery, and medical devices

Features: Novozymes debuted CGMP-grade hyaluronic acid (HA) derived from Bacillus culture at CPhI Worldwide 2011. Produced at a new facility in Tianjin, China, designed exclusively for its production, this HA is derived from a patented water-based process run in compliance with ICH Q7 guidelines. It is free of animal-derived components and organic solvents. GMP manufacturing provides for onsistent batches and tightly controlled molecular weight, fast dissolution, and autoclave heat stability. The product can be customized using proprietary cross-linking technology.

Contact Novozymes Biopharma www.biopharma.novozymes.com

Sample Protection

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Product: AssayAssure products and Refco UxF ultralow-temperature freezers

Applications: Sample collection, protection, and storage

Features: AssayAssure sample collection, transport, and storage products use a unique chemical formulation to protect samples from cell death or molecular degradation without refrigeration. Kits can be used for PCR, qPCR, and cellular (flow cytometry, microscopy, and culture) applications. And UxF series freezers store up to 72,000 2-mL or 118,300 1-mL Cryobank tubes in ≤=33.5 ft3. Touch-screen control panels offer an event log, health monitoring system, and controlled access options. Laboratories can choose/switch between high-performance and energy-saving modes.

Contact Thermo Fisher Scientific www.thermoscientific.com

Packaging Audits

Service: OEE consulting service

Applications: Final product fill and finish, packaging

Features: The overall equipment effectiveness (OEE) service from Bosch begins with an equipment audit to detect process-disturbing factors such as downtime, low machine output, and product waste. Experts gather data on machine availability, performance, and output quality, then statistically evaluate the results. Based on audit findings, consultants present a detailed plan of action to detect root causes and improve line efficiency. After equipment, maintenance, and/or training changes are implemented, continuous performance monitoring helps provide ongoing advice and document improvements.

Contact Bosch Packaging Technology www.boschpackaging.com

Sterile Fluid Transfer

Literature: BioFlex brochure

Applications: Bioprocessing

Features: A 2011 brochure from Meissner highlights the company’s BioFlex tubing assemblies for secure fluid transfer. It walks users through several common process configurations for connecting to and from single-use and stainless steel processing equipment. The tubing provides a secure path for filling assemblings and manifolds and sampling/flushing fluid transfers. Sterilizing-grade membrane filter capsule options listed include SteriLUX PVDF, STyLUX PES, and EverLUX PES filters, with additional media available for process stream sterilization, clarification, and sterile venting. This brochure also covers documentation and traceability features.

Contact Meissner Filtration Products www.meissner.com

Industrial Centrifuge

Product: APD-250 production centrifuge

Applications: Bioreactor harvest

Features: The Celeros model APD-250 centrifuge’s tubular bowl has a 40-L working volume. This unit can process bioreactor harvests ≤=10,000 L in a single shift. The large-scale production centrifuge generates ≤=20,000g of separating force, producing what the company calls “the driest paste and clearest centrate of any industrial centrifuge available for the biotech industry.” A patented Automatic Piston Discharge (APD) system completely transfers separated solids from the bowl without operator intervention or excessive centrate loss.

Contact Celeros Inc. www.celerosinc.com

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