Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays

Consistent performance of anti-drug antibody (ADA) assays through all stages of clinical development is critical for the assessment of immunogenicity and interpretation of PK, PD, safety, and efficacy. The electrochemiluminescent assays commonly employed for ADA measurement use drug conjugated with ruthenium and biotin to bind ADA in samples. Here we report an association between high nonspecific ADA responses in certain drug-naïve individuals and the storage buffer of the conjugated reagents used in a monoclonal antibody ADA assay. Ruthenylated reagents stored in phosphate-buffered saline (PBS) buffer had increased levels of aggregate and produced variable and high baseline responses in some subjects. Reagents stored in a histidine-sucrose buffer (HSB) had lower aggregate levels and produced low sample responses. In contrast to PBS, conjugated reagents formulated in HSB remained low in aggregate content and in sample response variability after 5 freeze/thaw cycles. A reagent monitoring control (RMC) serum was prepared for the real-time evaluation of conjugated reagent quality. Using appropriate buffers for storage of conjugated reagents together with RMCs capable of monitoring of reagent aggregation status can help ensure consistent, long-term performance of ADA methods.

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Preparation and Evaluation of Paracetamol Effervescent Tablets under Normal and Exaggerated Storage Conditions

Bangladesh Pharmaceutical Journal ◽

10.3329/bpj.v17i1.22320 ◽

2015 ◽

Vol 17 (1) ◽

pp. 75-78

Author(s):

Rehana Sultana ◽

Krishna Sarker ◽

Sakina Sultana

Keyword(s):

Pharmaceutical Journal ◽

Storage Conditions ◽

Bench Mark ◽

Content Uniformity ◽

Cool Temperature ◽

Performance Study ◽

Long Term Performance ◽

Term Performance ◽

Preparation And Evaluation

A single blind study was conducted to prepare and evaluate paracetamol effervescent tablets. Potency, content uniformity, diameter, thickness and crushing strength of the prepared tablets were used as the bench mark parameters for quality assessment. Our results showed that all parameters met official values except for friability. The performance of the tablets in terms of duration of effervescence was investigated under high stresses of humidity as well as at low and high temperatures. The duration of the investigational period lasted for 3 days and results showed an increase in effervescence time in each case. In this study, the normal effervescence time at 111.00±14.22 seconds was changed to 286.13±55.18 seconds, 140.38±21.59 seconds and 158.63±26.14 seconds under high humidity, at refrigeration (representing cool temperature) and at high temperature, respectively. Here, a long term performance study was also conducted under normal storage conditions spanning a period of 60 days. Duration of effervescence on day 1 was 212.54±0.34 seconds, but at the end of 60 days the duration increased to 634.23±0.65 seconds. In the present study the changes in organoleptic properties were also evaluated. Results showed that the properties remained the same over a period of 60 days while the potency of the drug reduced from 99% to 95%. DOI: http://dx.doi.org/10.3329/bpj.v17i1.22320 Bangladesh Pharmaceutical Journal 17(1): 75-78, 2014

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9975 Shipping Package: Performance of Alternate Materials for Long-Term Storage Application

ASME 2010 Pressure Vessels and Piping Conference: Volume 7 ◽

10.1115/pvp2010-25279 ◽

2010 ◽

Author(s):

T. E. Skidmore ◽

W. L. Daugherty ◽

E. N. Hoffman

Keyword(s):

Storage Conditions ◽

Test Results ◽

Savannah River ◽

Long Term Storage ◽

Additional Testing ◽

Long Term Performance ◽

Term Performance ◽

River Site ◽

Term Storage

The Model 9975 shipping package specifies the materials of construction for its various components. With the loss of availability of material for two components (cane fiberboard overpack and Viton® GLT O-rings), alternate materials of construction were identified and approved for use for transport (softwood fiberboard and Viton® GLT-S O-rings). The shipping packages are part of a long-term storage configuration at the Savannah River Site (SRS). Therefore, additional testing is in progress to verify satisfactory long-term performance of the alternate materials under storage conditions. The test results to date can be compared to results on the original materials of construction to draw preliminary conclusions on the performance of the replacement materials.

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Building the COllaborative Carbon Column Observing Network (COCCON): Long term stability and ensemble performance of the EM27/SUN Fourier transform spectrometer

10.5194/amt-2018-146 ◽

2018 ◽

Cited By ~ 1

Author(s):

Matthias Frey ◽

Mahesh Kumar Sha ◽

Frank Hase ◽

Matthäus Kiel ◽

Thomas Blumenstock ◽

...

Keyword(s):

Total Carbon ◽

Long Term Stability ◽

Long Term Study ◽

Ensemble Performance ◽

Instrumental Line ◽

Consistent Performance ◽

Institute Of Technology ◽

Long Term Performance ◽

Term Performance

Abstract. In a 3.5 year long study, the long term performance of a mobile Bruker EM27/SUN spectrometer, used for greenhouse gases observations, is checked with respect to a co-located reference Bruker IFS 125HR spectrometer, which is part of the Total Carbon Column Observing Network (TCCON). We find that the EM27/SUN is stable on timescales of several years, qualifying it as an useful supplement for the existing TCCON network in remote areas. For achieving consistent performance, such an extension requires careful testing of any spectrometers involved by application of common quality assurance measures. One major aim of the COllaborative Carbon Column Observing Network (COCCON) infrastructure is to provide these services to all EM27/SUN operators. In the framework of COCCON development, the performance of an ensemble of 30 EM27/SUN spectrometers was tested and found to be very uniform, enhanced by the centralized inspection performed at the Karlsruhe Institute of Technology prior to deployment. Taking into account measured instrumental line shape parameters for each spectrometer, the resulting average bias across the ensemble in XCO2 is 0.20 ppm, while it is 0.8 ppb for XCH4. As indicated by the executed long-term study on one device presented here, the remaining empirical calibration factor deduced for each individual instrument can be assumed constant over time. Therefore the application of these empirical factors is expected to further improve the EM27/SUN network conformity beyond the raw residual bias reported above.

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