Abstract: A bioreactor system may include (a) two or more fluidically coupled vessels configured to collectively carry out a bioreaction; (b) one or more fluidic paths coupling the two or more vessels to one another, where the fluidic paths are configured to provide flow of culture medium between the two or more vessels; (c) one or more fluid transfer devices along at least some of the one or more fluidic paths; and (d) a control system. The control system may be configured to (i) read or receive values of one or more parameters characterizing the culture medium in one or more of the vessels, and (ii) use the values to determine an adjusted flow rate in at least one of the fluidic paths to maintain substantially uniform values of the one or more parameters in the culture medium from vessel-to-vessel among the two or more vessels.

Abstract: A cylindrical or annular polymeric bioreactor is disclosed which provides enhanced mixing and aeration of the growth medium while simultaneously offering reduced mechanical shear force.

Abstract: Disclosed herein are apparatuses and methods for installing a sterilized peripheral in a bio-processing vessel. One aspect is an aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel via an aseptic connector affixed to the vessel. The aseptic peripheral connection assembly may include a carrier, an applicator, a plunger, and a removable hermetic sealing tab.

Abstract: A composite sensor assembly for monitoring bio-processes which is suitable for use with a polymeric bioprocess vessel or with downstream equipment, and comprises: i) a port comprising a high surface tension thermoplastic having a hollow tubular portion and a base plate portion, the base plate portion being fusibly sealable to the bioreactor vessel at a hole in the wall thereof; ii) a generally opaque polymeric monitoring sensor assembly including electrical, and/or optical measurement components. The sensor assembly tits inside the bore of the hollow tubular portion of the port, and is adhesively retained therein.

Abstract: Disclosed herein are apparatuses and methods for installing a sterilized peripheral in a bio-processing vessel or component. One aspect is an aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel or component via an aseptic connector affixed to the vessel or component. The aseptic peripheral connection assembly may include a carrier, an applicator, and a removable hermetic sealing tab.

Abstract: A composite sensor assembly for monitoring bio-processes which is suitable for use with a polymeric bioprocess vessel or with downstream equipment, and comprises: i) a port comprising a high surface tension thermoplastic having a hollow tubular portion and a base plate portion, the base plate portion being fusibly sealable to the bioreactor vessel at a hole in the wall thereof; ii) a generally opaque polymeric monitoring sensor assembly including electrical, and/or optical measurement components. The sensor assembly fits inside the bore of the hollow tubular portion of the port, and is adhesively retained therein.

Abstract: Disclosed herein are apparatuses and methods for installing a sterilized peripheral in a bio-processing vessel or component. One aspect is an aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel or component via an aseptic connector affixed to the vessel or component. The aseptic peripheral connection assembly may include a carrier, an applicator, and a removable hermetic sealing tab.

Abstract: Disclosed herein are apparatuses and methods for installing a sterilized peripheral in a bio-processing vessel. One aspect is an aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel via an aseptic connector affixed to the vessel. The aseptic peripheral connection assembly may include a carrier, an applicator, a plunger, and a removable hermetic sealing tab.

Abstract: A data management system for a biological process, comprising: a. a single-use component, b. a tag assembly, including a non-volatile memory storage component, that is associated with the single-use component, c. the memory storage component including a unique identification and a memory, and at least one data element that describes a key performance, calibration or control parameter of the single-use component d. a memory reader useable to obtain the identification from the memory storage component.

Abstract: A multi-analyte sensor system based on hollow core photonic bandgap fiber and Raman anti-Stokes spectroscopy. The system includes: i) an inlet to introduce an analyte sample into an analyzer chamber which analyzer includes; ii) a measurement system to derive the anti-Stokes spectral peaks and/or spectra of the sample; iii) a set of reference calibrants corresponding to the analytes of which the sample is primarily comprised; iv) a second inlet to introduce said calibrants into the analyzer chamber; v) a second measurement system to derive the anti-Stokes spectral peaks and/or spectra of the calibrants vi) an outlet through which the sample and calibrants are expelled from the analyzer chamber.

Abstract: A composite sensor assembly for monitoring bio-processes which is suitable for use with a polymeric bioprocess vessel or with downstream equipment, and comprises: i) a port comprising a high surface tension thermoplastic having a hollow tubular portion and a base plate portion, the base plate portion being fusibly sealable to the bioreactor vessel at a hole in the wall thereof; ii) a generally opaque polymeric monitoring sensor assembly including electrical, and/or optical measurement components. The sensor assembly fits inside the bore of the hollow tubular portion of the port, and is adhesively retained therein.

Abstract: A composite sensor assembly for monitoring bio-processes which is suitable for use with a polymeric bioprocess vessel or with downstream equipment, and comprises: i) a port comprising a high surface tension thermoplastic having a hollow tubular portion and a base plate portion, the base plate being fusibly sealable to the bioreactor vessel at a hole in the wall thereof; ii) a generally opaque polymeric monitoring sensor assembly including electrical, and/or optical measurement components. The sensor assembly fits inside the bore of the hollow tubular portion of the port, and is adhesively retained therein.

Abstract: A port for use with a bioreactor vessel comprising: i) a base member comprising a hollow tubular portion and a base plate configured to be sealingly affixed to a hole in the wall of a bioreactor vessel ii) a hollow, generally tubular bushing member for containing electrical, optical, microfluidic and/or chemical monitoring components which bushing member fits inside the bore of the tubular portion of the base member, both the base member and bushing member providing access to the contents of a bioreactor by; iii) a monitoring assembly inserted into the bushing member which assembly comprises means for providing incoming optical and/or electrical signals and means for collecting and transmitting measurement signals resulting from the interaction of incoming optical and/or electrical signals with the contents of a bioreactor; and iv) a cover which maintains the position and alignment of components ii) and iii) relative to the base member.

Abstract: A bioreactor monitoring and/or control system utilizing only non-dedicated user input and information display devices, a digital controller and software, said system comprising: i) at least one diagnostic probe for measuring operating conditions in a bioreactor; ii) signal conditioning and communication electronics which supply operating current and/or voltage to said probe and which convert the diagnostic signal into a format accessible by iii) a digital controller which directly receives the format converted signal and transmits it to iv) software which enables the display device to show the converted signal, and also to instruct the controller to implement changes in the operating conditions in the reactor, and v) a software-based virtual transmitter which substantially replicates the keyboard, display, menu-tree and response of a physical sensor transmitter.

Abstract: A port assembly for use with a polymeric bioreactor bag includes the following components: i) a hollow port member made from a material which can be fusibly affixed to the wall surface of the bioreactor bag; ii) at least one fluorophore spot positioned on the port member; iii) a conduit for conveying excitation light from an optical source to the fluorophore, which conduit can be a lens, a curved parabolic collimator, a shaped reflector or a wave guide; and iv) a second conduit for conveying fluorescent emission light from the excited fluorophore to a photo-detector, which second conduit although different from the first, can likewise be a lens, a curved parabolic collimator, a shaped reflector or a wave guide.

Abstract: A data management system for a biological process, comprising: a. a single-use component, b. a tag assembly, including a non-volatile memory storage component, that is associated with the single-use component, c. the memory storage component including a unique identification and a memory, and at least one data element that describes a key performance, calibration or control parameter of the single-use component d.

Abstract: An optical loss probe utilized as a bioreactor process monitor manifesting a substantially linear response in optical loss vs. concentration of scatterers present in an aqueous medium in the range of between about 0 AU and about 4.0 AU, said probe comprising: i) a light source, ii) an optical detector, and iii) an optical gap between said light source and said optical detector, said optical detector having a receiving aperture configured such that the solid angle of acceptance of the light passing through said optical gap and impinging on said optical detector is less than ?/50 radians.

Abstract: This invention relates to methods for monitoring and controlling bioprocesses. Specifically, it describes using quasi-real-time analytical and numerical techniques to analyze optical loss measurements calibrated to indicate cell viability, whereby it is possible to reveal process changes and/or process events such as feeding or induction. Additionally, the present invention makes it possible to accurately estimate the onset of a decrease in cell viability and/or a suitable time for cell harvesting for a cell culture growth process. Pattern recognition methods for identifying specific process events such as batch feeding, cell infection, and product precipitation are also described.

Abstract: An apparatus and method for the stimulation and collection of fluorescent signals from a target analyte. The apparatus comprises: i) a frequency modulated optical source which emits excitation light of a wavelength which will stimulate a target fluorophore to emit a fluorescent signal when illuminated by the excitation light, ii) a first optical filter interposed between the optical source and the target fluorophore, iii) a second optical filter interposed between the fluorophore and a photo-detector and positioned to receive the emitted fluorescent signal. The beam path of at least one, preferably both, of the excitation light and the fluorescent signal is transmitted substantially through free space. A data processor will normally be used to calculate and record the phase delay between the excitation light and the fluorescent signal.

Abstract: An optical loss probe utilized as a bioreactor process monitor manifesting a substantially linear response in optical loss vs. concentration of scatterers present in an aqueous medium in the range of between about 1 AU and about 4.0 AU, said probe comprising: i) a light source, ii) an optical detector, and iii) an optical gap between said light source and said optical detector, said optical detector having a receiving aperture configured such that the solid angle of acceptance of the light passing through said optical gap and impinging on said optical detector is less than ?/50 radians.