It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China



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New method development for PK and immunogenicity for large molecule

12 Nov 2018

Lambda has successfully developed and validated bioanalytical methods to support pharmacokinetics measurement and immunogenicity assessment of Romiplostim. Romiplostim is a fusion protein analog of Thrombopoietin and is indicated for treatment of chronic idiopathic (immune) thrombocytopenic purpura (ITP).

The pharmacokinetic measurement assay is a sandwich ELISA based ligand binding assay, which employs anti-romiplostim antibody as capture and biotin conjugated anti-romiplostim antibody as detection reagent. The endpoint is colorimetric and is measured in terms of Optical Density. The assay is extremely sensitive with the lowest limit of quantification at 40 pg/mL and is selective and specific to detect and quantify low serum levels of romiplostim.

An electro-chemiluminescence immunoassay (ECLIA) has been developed for immunogenicity assessment of romiplostim. The assay is based on bridging format and employs biotin conjugated romiplostim and sulfotag conjugated romiplostim for capture and detection of anti–romiplostim antibodies, respectively.

The bioanalytical romiplostim methods were used to support a Phase III trial of the biosimilar of N-Plate (Amgen Inc.) and the results obtained were corroborating with the reported data of N-Plate by Amgen Inc.

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