scholarly journals Microwave-Assisted Freeze-Drying of Monoclonal Antibodies: Product Quality Aspects and Storage Stability

Pharmaceutics ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 674
Author(s):  
Julian Hendryk Gitter ◽  
Raimund Geidobler ◽  
Ingo Presser ◽  
Gerhard Winter
Keyword(s):  
Monoclonal Antibodies ◽  
Freeze Drying ◽  
Storage Stability ◽  
Moisture Distribution ◽  
General Applicability ◽  
Residual Moisture ◽  
Microwave Assisted ◽  
Freeze Dried ◽  
Quality Aspects ◽  
Related Quality

In order to overcome the downside of long conventional freeze-drying (CFD) process times for monoclonal antibody formulations, microwave-assisted freeze-drying (MFD) was introduced. Recently, the general applicability and potential shortening of drying times were shown. However, little is known about the storage stability of MFD products compared to CFD references. Additionally, batch homogeneity issues were seen within MFD in the past. In this study, we examined four different formulations of two different monoclonal antibodies using three different glass-forming excipients: sucrose, trehalose, and arginine phosphate. These formulations were freeze-dried with two different drying protocols (CFD and MFD), stored for 24 weeks, and analyzed for solid-state and protein-related quality attributes. Moreover, a new microwave generator setup was investigated for its potential to improve batch homogeneity. In all investigated formulations, comparable stability profiles were found, although the classical magnetron generator led to inferior batch homogeneity with respect to residual moisture distribution. In contrast, the new MFD setup indicated the potential to approximate batch homogeneity to the level of CFD. However, for future applications, there is an unabated need for new machine designs to comply with pharmaceutical manufacturing requirements.

Viability of microencapsulated Akkermansia muciniphila and Lactobacillus plantarum during freeze-drying, storage and in vitro simulated upper gastrointestinal tract passage

2018 ◽  
Vol 9 (11) ◽  
pp. 5868-5879 ◽  
Author(s):  
Martín Sebastián Marcial-Coba ◽  
Tomasz Cieplak ◽  
Thiago Barbosa Cahú ◽  
Andreas Blennow ◽  
Susanne Knøchel ◽  
...  
Keyword(s):  
Gastrointestinal Tract ◽  
Lactobacillus Plantarum ◽  
Freeze Drying ◽  
Storage Stability ◽  
Upper Gastrointestinal Tract ◽  
Akkermansia Muciniphila ◽  
Freeze Dried ◽  
Upper Gastrointestinal

Microencapsulated and subsequently freeze-dried cells showed acceptable storage stability and enhanced survival during in vitro upper gastrointestinal tract passage.

scholarly journals Freeze-Drying of Plant Tissue Containing HBV Surface Antigen for the Oral Vaccine against Hepatitis B

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Marcin Czyż ◽  
Radosław Dembczyński ◽  
Roman Marecik ◽  
Justyna Wojas-Turek ◽  
Magdalena Milczarek ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Freeze Drying ◽  
Elevated Temperatures ◽  
Oral Vaccine ◽  
Leaf Tissue ◽  
Residual Moisture ◽  
Small Surface ◽  
Process Step ◽  
Freeze Dried

The aim of this study was to develop a freeze-drying protocol facilitating successful processing of plant material containing the small surface antigen of hepatitis B virus (S-HBsAg) while preserving its VLP structure and immunogenicity. Freeze-drying of the antigen in lettuce leaf tissue, without any isolation or purification step, was investigated. Each process step was consecutively evaluated and the best parameters were applied. Several drying profiles and excipients were tested. The profile of 20°C for 20 h for primary and 22°C for 2 h for secondary drying as well as sucrose expressed efficient stabilisation of S-HBsAg during freeze-drying. Freezing rate and postprocess residual moisture were also analysed as important factors affecting S-HBsAg preservation. The process was reproducible and provided a product with VLP content up to 200 µg/g DW. Assays for VLPs and total antigen together with animal immunisation trials confirmed preservation of antigenicity and immunogenicity of S-HBsAg in freeze-dried powder. Long-term stability tests revealed that the stored freeze-dried product was stable at 4°C for one year, but degraded at elevated temperatures. As a result, a basis for an efficient freeze-drying process has been established and a suitable semiproduct for oral plant-derived vaccine against HBV was obtained.

scholarly journals Storage Stability of Encapsulated Black Carrot Powder Prepared Using Spray and Freeze-Drying Techniques

2019 ◽  
Vol 7 (2) ◽  
pp. 261-267 ◽  
Author(s):  
Subramani Murali ◽  
Avinash Singh Patel ◽  
Abhijit Kar
Keyword(s):  
Half Life ◽  
Freeze Drying ◽  
Storage Stability ◽  
Color Change ◽  
Degradation Kinetics ◽  
Storage Period ◽  
Gum Arabic ◽  
Anthocyanin Content ◽  
Black Carrot ◽  
Freeze Dried

The present study was aimed to investigate the storage stability encapsulated black carrot powder obtained under the optimized conditions of spray drying of 150°C of inlet air temperature and freeze-drying with maltodextrin, gum arabic and tapioca starch as the combined carrier materials.Effect of two types of vial as a storing material viz., transparent and amber colored was used in this study and study was observed for the period of 90 days. Anthocyanin content, antioxidant activity, total color change and half-life period were monitored at 15 days interval throughout the storage period. The anthocyanins degradation rate followed first order kinetics. The storage half-life of spray and freeze-dried encapsulated material stored under airtight amber color vials was predicted up to 130 and 155 days with total degradation kinetics of 33% and 38%. However, the storage self-life spray and freeze-dried encapsulated material stored under airtight transparent vial was predicted up to 109 and 134 days with total antocyanin degradation of 37% and 43%, respectively.

Viability, Efficacy, and Storage Stability of Freeze-Dried Biocontrol Agent Candida sake Using Different Protective and Rehydration Media

2001 ◽  
Vol 64 (6) ◽  
pp. 856-861 ◽  
Author(s):  
M. ABADIAS ◽  
N. TEIXIDÓ ◽  
J. USALL ◽  
A. BENABARRE ◽  
I. VIÑAS
Keyword(s):  
Freeze Drying ◽  
Storage Stability ◽  
Storage Temperature ◽  
Penicillium Expansum ◽  
Freeze Dried ◽  
Skimmed Milk ◽  
The Stability ◽  
Candida Sake ◽  
Initial Starting ◽  
And Storage

Viability, efficacy against Penicillium expansum on Golden Delicious apples, and storage stability of freeze-dried Candida sake strain CPA-1 were studied. The effect of several protective agents and rehydration media was investigated in the freeze drying of C. sake. Skimmed milk at 10% concentration was a good rehydration medium for all protectants tested. In general, good viability results were obtained when the same solution was used as a protectant and as a rehydration medium. The best survival was obtained when C. sake cells were protected with 10% lactose + 10% skimmed milk and rehydrated with skimmed milk (85% viability). The potential for biocontrol of the best freeze-dried treatments against P. expansum on apples was compared with that of fresh cells. Freeze-dried treatments at 1 × 107 CFU/ml reduced the incidence of decay by 45 to 66%. The best biocontrol effect was obtained with cells that had been freeze dried using 10% lactose + 10% skimmed milk as a protectant and 1% peptone as a rehydration medium, with a 66% reduction in rot incidence. However, in all treatments, the efficacy of freeze-dried cells was significantly lower than fresh cells. The stability of freeze-dried samples decreased during storage and was influenced by storage temperature. In the best treatment, storage of C. sake cells for 60 days at 4°C resulted in final concentrations of 2.5 × 108 CFU/ml, which was a 10-fold reduction in relation to the initial starting concentration of cells prior to freeze drying.

scholarly journals Evaluation of Freeze Drying and Electrospinning Techniques for Saffron Encapsulation and Storage Stability of Encapsulated Bioactives

2021 ◽  
Vol 5 (12) ◽  
pp. 326
Author(s):  
Fatemeh Golpira ◽  
Neda Maftoonazad ◽  
Hosahalli S. Ramaswamy
Keyword(s):  
Bioactive Compounds ◽  
Encapsulation Efficiency ◽  
Freeze Drying ◽  
Storage Stability ◽  
Control Sample ◽  
Storage Period ◽  
Diameter Distribution ◽  
Freeze Dried ◽  
Drying Techniques ◽  
Saffron Extract

Saffron extract was encapsulated into a gelatin matrix by means of electrospinning and freeze drying techniques and the degradation kinetics of bioactive compounds were evaluated during their storage at 4, 24, and 35 °C as compared to non-encapsulated control. The encapsulation efficiency, thermal properties, storage stability, morphology, and diameter distribution of the encapsulated saffron extract were evaluated as output parameters. In general, both encapsulation techniques demonstrated superior retention of bioactive compounds compared to samples without encapsulation during the entire storage period. Electrospinning and freeze drying techniques were able to retain at least 96.2 and 93.7% of crocin, respectively, after 42 days of storage at 35 °C with the 15% saffron extract. The half-life (t1/2) time parameter for the control sample (with 15% saffron extract without encapsulation) was 22 days at 4 °C temperature, while that encapsulated by electrospinning was 138 days and that obtained for freeze drying was 77 days, The half-lives were longer at lower temperatures. The encapsulation efficiency of crocin, picrocrocin, and safranal associated with the electro-spun gelatin fibers were 76.3, 86.0, and 74.2%, respectively, and in comparison, the freeze drying encapsulation efficiencies were relatively lower, at 69.0, 74.7, and 65.8%, respectively. Electro-spun gelatin fibers also had higher melting and denaturation temperatures of 78.3 °C and 108.1 °C, respectively, as compared to 65.4 °C and 93.2 °C, respectively, for freeze-dried samples. Thus, from all respects, it was concluded that electrospinning was a better and more effective technique than freeze drying in terms of preserving saffron bioactive compounds.

scholarly journals Room-temperature-storable PCR Mixes for SARS-CoV-2 Detection

2020 ◽  
Author(s):  
Jiasu Xu ◽  
Jin Wang ◽  
Zecheng Zhong ◽  
Xiaosong Su ◽  
Kunyu Yang ◽  
...  
Keyword(s):  
Freeze Drying ◽  
Room Temperature ◽  
Karl Fischer Titration ◽  
Residual Moisture ◽  
Ambient Temperatures ◽  
Logistics Networks ◽  
Rapid Pcr ◽  
Freeze Dried ◽  
Novel Coronavirus ◽  
Sensitivity Specificity

AbstractA novel coronavirus (severe acute respiratory syndrome coronavirus 2, SARS-CoV-2) emerged in late 2019, causing an outbreak of pneumonia [coronavirus disease 2019 (COVID-19)] in Wuhan, China, which then rapidly spread globally. Although the use of ready-made reaction mixes can enable more rapid PCR-based diagnosis of COVID-19, the need to transport and store these mixes at low temperatures presents challenges to already overburdened logistics networks. Here, we present an optimized freeze-drying procedure that allows SARS-CoV-2 PCR mixes to be transported and stored at ambient temperatures, without loss of activity. Additive-supplemented PCR mixes were freeze-dried. The residual moisture of the freeze-dried PCR mixes was measured by Karl-Fischer titration. We found that freeze-dried PCR mixes with ∼1.2% residual moisture are optimal for storage, transport, and reconstitution. The sensitivity, specificity, and repeatability of the freeze-dried reagents were similar to those of freshly prepared, wet reagents. The freeze-dried mixes retained activity at room temperature (18∼25°C) for 28 days, and for 14 and 10 days when stored at 37°C and 56°C, respectively. The uptake of this approach will ease logistical challenges faced by transport networks and make more cold storage space available at diagnosis and hospital laboratories. This method can also be applied to the generation of freeze-dried PCR mixes for the detection of other pathogens.

Scanning Electron Microscopy-cuticular Lesions on the Roundworm Ascaris Suum

1970 ◽  
Vol 28 ◽  
pp. 114-115
Author(s):  
P. A. Madden ◽  
W. R. Anderson
Keyword(s):  
Electron Microscopy ◽  
Scanning Electron Microscopy ◽  
Freeze Drying ◽  
Room Temperature ◽  
Secondary Electron ◽  
Distilled Water ◽  
Freeze Dried ◽  
Silver Paint ◽  
To Come ◽  
Scanning Electron

The intestinal roundworm of swine is pinkish in color and about the diameter of a lead pencil. Adult worms, taken from parasitized swine, frequently were observed with macroscopic lesions on their cuticule. Those possessing such lesions were rinsed in distilled water, and cylindrical segments of the affected areas were removed. Some of the segments were fixed in buffered formalin before freeze-drying; others were freeze-dried immediately. Initially, specimens were quenched in liquid freon followed by immersion in liquid nitrogen. They were then placed in ampuoles in a freezer at −45C and sublimated by vacuum until dry. After the specimens appeared dry, the freezer was allowed to come to room temperature slowly while the vacuum was maintained. The dried specimens were attached to metal pegs with conductive silver paint and placed in a vacuum evaporator on a rotating tilting stage. They were then coated by evaporating an alloy of 20% palladium and 80% gold to a thickness of approximately 300 A°. The specimens were examined by secondary electron emmission in a scanning electron microscope.

Revealing gross three-dimensional structure in the SEM

1987 ◽  
Vol 45 ◽  
pp. 656-657
Author(s):  
Sterling P. Newberry
Keyword(s):  
Freeze Drying ◽  
Three Dimensional ◽  
Dimensional Structure ◽  
Small Object ◽  
Final Solution ◽  
Dimensional Representation ◽  
X Ray ◽  
Three Dimensional Representation ◽  
Freeze Dried ◽  
Critical Point Drying

The beautiful three dimensional representation of small object surfaces by the SEM leads one to search for ways to open up the sample and look inside. Could this be the answer to a better microscopy for gross biological 3-D structure? We know from X-Ray microscope images that Freeze Drying and Critical Point Drying give promise of adequately preserving gross structure. Can we slice such preparations open for SEM inspection? In general these preparations crush more readily than they slice. Russell and Dagihlian got around the problem by “deembedding” a section before imaging. This some what defeats the advantages of direct dry preparation, thus we are reluctant to accept it as the final solution to our problem. Alternatively, consider fig 1 wherein a freeze dried onion root has a window cut in its surface by a micromanipulator during observation in the SEM.

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