Can lyophilized proteins remain stable during room-temperature shipping or temporary room-temperature exposure?

Question

Accepted Answer

In general, lyophilized proteins remain stable during room-temperature shipping or temporary exposure to room-temperature conditions.

Many ACROBiosystems recombinant proteins are supplied in lyophilized (freeze-dried) form. The lyophilization process effectively removes moisture from the product, helping reduce degradation-related reactions and improve protein stability during transportation and storage.

To evaluate the stability of lyophilized proteins under normal temperature conditions, ACROBiosystems conducted a stability study on 11 representative lyophilized protein products at 37°C. The study demonstrated that these proteins maintained good quality stability after storage at 37°C for approximately 20 days. Based on these validation results, temporary room-temperature exposure during shipping or handling is generally not expected to have a significant impact on product quality or downstream application performance.

To ensure optimal long-term stability, products should be stored according to the storage conditions specified in the product Certificate of Analysis (COA) upon receipt.

Supporting Document

Validation Report for Accelerated Stability Study of 11 Lyophilized Proteins

Source	This Monoclonal Anti-VHH Antibody, Rabbit IgG is a rabbit monoclonal antibody recombinantly expressed from HEK293.
Specificity	This antibody can react with Humanized and Alpaca VHHs.
Cross-Reactivity	No cross-reactivity was observed with human IgG1, human IgG4, mouse IgG2a, rabbit IgG, and rat IgG. Weak cross-reactivity was observed with mouse IgG1 or mouse IgG2b at concentrations below 1 μg/mL.
Formulation	Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with trehalose as protectant.
Physical Appearance	Powder
Storage (unopened)	-20°C to -70°C
Storage (opened)	-70°C
Unit Size	1000 tests & 5000 tests & 20000 tests
Technology	TR-FRET
Intended Use	For binding the Humanized and Alpaca VHHs as Acceptor in TR-FRET Assay

Monoclonal Anti-VHH Antibody FA-Labeled (for TR-FRET)

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