A method for freeze-drying a hydrogel composition is disclosed, the method comprising providing the hydrogel composition, wherein the hydrogel composition comprises cellulose nanofibrils and/or cellulose nanocrystals, at least one saccharide, at least one amino acid, and biologics; and freeze-drying the hydrogel composition, thereby obtaining a freeze-dried hydrogel composition.

A method for freeze-drying a hydrogel composition is disclosed, the method comprising providing the hydrogel composition, wherein the hydrogel composition comprises cellulose nanofibrils and/or cellulose nanocrystals, at least one saccharide, at least one amino acid, and biologics; and freeze-drying the hydrogel composition, thereby obtaining a freeze-dried hydrogel composition.

A method of monitoring and controlling a freeze drying process in a freeze drying apparatus having walls, shelves and a number of vials or trays positioned on different areas of the shelves and containing product to be freeze dried. One or more vials or trays are selected that are representative of the positions of all of the vials or trays in different areas of the shelves. One or more heat flux sensors are positioned between the selected vials or trays and adjacent portions of the walls and/or shelves. The heat transfer between the selected vials or trays and the adjacent wall or shelf portions is measured during the freezing and drying stages of the freeze drying process.

A method of monitoring and controlling a freeze drying process in a freeze drying apparatus having walls, shelves and a number of vials or trays positioned on different areas of the shelves and containing product to be freeze dried. One or more vials or trays are selected that are representative of the positions of all of the vials or trays in different areas of the shelves. One or more heat flux sensors are positioned between the selected vials or trays and adjacent portions of the walls and/or shelves. The heat transfer between the selected vials or trays and the adjacent wall or shelf portions is measured during the freezing and drying stages of the freeze drying process.

The present disclosure provides a method of producing a population of lyophilized cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; and (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells. On some embodiments, the disclosure provides a method of producing a population of reconstituted viable cells, comprising: (a) freezing a composition comprising a population of cells, an aqueous component, a polyol, a sugar, and a polysaccharide; (b) removing at least 90% of the aqueous component from the frozen composition to produce the population of lyophilized cells, and (c) resuspending the population of lyophilized cells in a reconstitution agent to form a reconstituted composition, wherein at least 1% of the cells are viable.

An arrangement for monitoring an aseptic manufacturing process includes product condition sensors capable of making closely spaced measurements of a product condition such as temperature or humidity. The measurements are made using closely spaced sensors arranged in a linear array on a single probe, which may be used to take measurements at multiple levels within the product. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The sensors may be used to measure temperature and humidity at a single point. For example, when the sensors are used in pharmaceutical freeze drying, the location of a sublimation front may be calculated for each vial, and the freeze drying process may be controlled using the data.

An arrangement for monitoring an aseptic manufacturing process includes product condition sensors capable of making closely spaced measurements of a product condition such as temperature or humidity. The measurements are made using closely spaced sensors arranged in a linear array on a single probe, which may be used to take measurements at multiple levels within the product. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The sensors may be used to measure temperature and humidity at a single point. For example, when the sensors are used in pharmaceutical freeze drying, the location of a sublimation front may be calculated for each vial, and the freeze drying process may be controlled using the data.

An object of the present invention is to provide a new freeze-dried article that is easy to handle and a producing method thereof. A freeze-dried structure of the present invention includes a freeze-dried article and a support member, wherein the support member has an embedded region and a protruding region, the embedded region of the support member is embedded in the internal portion of the freeze-dried article, and the protruding region of the support member protrudes outward from the freeze-dried article.

An object of the present invention is to provide a new freeze-dried article that is easy to handle and a producing method thereof. A freeze-dried structure of the present invention includes a freeze-dried article and a support member, wherein the support member has an embedded region and a protruding region, the embedded region of the support member is embedded in the internal portion of the freeze-dried article, and the protruding region of the support member protrudes outward from the freeze-dried article.

Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.