Abstract:
The present invention relates to novel and improved methods for the purification of biomolecules. In particular, the present invention relates to methods of protein purification which employ small molecules, which include at least one non-polar group and at least one cationic group or which include at least one non-polar group and at least one anionic group.
Abstract:
A method and apparatus for providing more reliable wireless communication and power to sensors in electrically challenging bioprocess environments is disclosed. An unconnected antenna is located within the bioprocess environment, preferably in the same plane as the primary powered antenna. This unconnected antenna, also referred to as reflective antenna, enhances and confines the electromagnetic field created by the powered antenna. This reflective antenna is incorporated in or proximate to the devices containing a sensor or communication device. In one embodiment, the reflective antenna is incorporated into the filter housing. In another embodiment, it is incorporated into the filtering element itself. In another embodiment, it is incorporated into or affixed on the disposable bioprocess components, such as bags and tubes.
Abstract:
Media and devices, such as anion exchangers including such media, wherein the media is a membrane having a surface coated with a polymer such as a polyallylamine. The resulting membrane offers stronger binding of protein impurities and superior removal of host cell proteins from biological samples than conventional ligands based on quaternary ammonium salts, including trimethylammonium ligands. Also described is a chromatography scheme and method for purifying monoclonal antibodies, wherein the anion exchange sorber is placed downstream of an affinity column (such as Protein A or Protein G affinity column) and optionally one or more polishing devices such as cationic exchange columns. Little or no dilution of the cation exchanger pool (or affinity column exchange pool where no cation exchanger is used) is necessary to lower the conductivity of the sample. The sorber functions well to strongly bind host cell proteins and other impurities even at high conductivities and pH.
Abstract:
A valved microfluidics device, microfluidics cell-culture device and system incorporating the devices are disclosed. The valved microfluidics device includes a substrate, a microchannel through which liquid can be moved from one station to another within the device, and a pneumatic microvalve adapted to be switched between open and closed states to control the flow of fluid through a microchannel. The microvalve is formed of three flexible membranes, one of which is responsive to pneumatic pressure applied to the valve and the other two of which deform to produce a more sealable channel cross-section. The cell culture device provides valving to allow controlled loading of cells into the individual well of the device, and exchange of cell-culture components in the wells.
Abstract:
Adsorbent filter media particularly suited for removal of biological contaminants in process liquids. A porous fixed bed of adsorbent material is formed, using only a granular adsorbent and a water-insoluble thermoplastic binder. The resulting composite filter allows for a higher amount of adsorbent with smaller adsorbent particles than conventional depth filters. Elimination of cellulose fiber, as well as the elimination of the thermoset binder, results in reduced contamination of the process liquid.
Abstract:
A system and method for implementing embedded electronics in environments where radiation or extreme temperatures are used is disclosed. Embedded electronics are affixed to various components of a pharmaceutical system, thereby enabling the customer to download pertinent information about the component, such as lot number, date of manufacturer, test parameters, etc. Additionally, these electronics allow an array of functions and features to be implemented, such as integrity tests and diagnostics. The electronics in the pharmaceutical components utilize a technology that is not as susceptible to radiation and extreme temperatures as traditional electronics.
Abstract:
The biocontainer of the present invention provides a low cost, simple solution of many of the problems encountered during shipping, freezing and thawing of biopharmaceutical materials. The present invention enables a user to monitor the temperature profile of each biopharmaceutical container during the cryogenic process, so as to ensure the integrity of materials within each biocontainer by using a pre-installed and pre-sterilized temperature sensor. In some embodiments, the sensor assembly includes a wireless transmitter and is capable of transmitting information regarding the measured reading. In other embodiments, the sensor assembly includes a processing unit, which determines whether the temperature profile is acceptable. In a further embodiment, an indicator is included, such that the processing unit may indicate whether the biopharmaceutical material has been properly frozen. In other embodiments, the sensor assembly also includes a storage element, which is capable of storing various parameters during the freezing process.
Abstract:
The biocontainer of the present invention provides a low cost, simple solution of many of the problems encountered during shipping, freezing and thawing of biopharmaceutical materials. The present invention enables a user to monitor the temperature profile of each biopharmaceutical container during the cryogenic process, so as to ensure the integrity of materials within each biocontainer by using a pre-installed and pre-sterilized temperature sensor. In some embodiments, the sensor assembly includes a wireless transmitter and is capable of transmitting information regarding the measured reading. In other embodiments, the sensor assembly includes a processing unit, which determines whether the temperature profile is acceptable. In a further embodiment, an indicator is included, such that the processing unit may indicate whether the biopharmaceutical material has been properly frozen. In other embodiments, the sensor assembly also includes a storage element, which is capable of storing various parameters during the freezing process.
Abstract:
Filtration device suited for concentration of liquid samples, particularly biomolecules, and a method of concentrating, desalting, purifying and/or fractionating liquid samples. In certain embodiments the device includes a housing having a sample reservoir, and two substantially vertically oriented and spaced apart membranes disposed in the housing. An underdrain is associated with each membrane such that fluid passing through each membrane flows through a respective underdrain into a filtrate collection chamber. The fluid that does not pass through the membrane is collected in the retentate collection chamber, and can be recovered such as by a reverse spinning step, achieving recoveries greater than about 90%. The substantially vertical orientation of the membranes increases the available membrane area by at least 2.7 times the area available in a conventional filter device. The two-panel configuration also maintains more available membrane area in use during the last stages of filtration than a one-panel configuration.