Author: admin

New method development for PK and immunogenicity for large molecule

  |   Panomics   |   No comment

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...

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Refuse to Receive Standards

  |   Regulatory   |   No comment

ANDA Submissions- “refuse to receive standards” Draft Guidance   Prepared by: Mr. Bhavesh J. Rathod, Mr. Nishant R. Christian & Mr. Manoj K. Patel Over the years, there have been many questions raised by the applicants of Abbreviated new drug applications regarding “refuse to receive standards” (RTR) and...

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An Expansion of Excellence

  |   lambdanews   |   No comment

At Lambda, we believe excellence is a continuous journey. Therefore, since inception, we have steadily evolved and grown in potential by adding new services to our portfolio, training our employees, upgrading our technologies and accelerating the journey of molecule to the market for the benefit...

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