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Nextcea Inc.

Woburn, Massachusetts, US

Nextcea, Inc. is a pharmaceutical service company dedicated to optimizing efficacy, minimizing toxicity, and ensuring the quality of drug products through all phases of drug development and biotherapeutic bioequivalence. Nextcea performs customized services in support of discovery, preclinical and clinical stage research and biological therapeutic development.

  • Biotherapeutic Antibody / Bioconjugate Characterization
  • Biomarkers
  • Drug-Induced Phospholipidosis
  • Analytical Method Development & Validation
  • Sample Analysis (non-GLP/GLP)
  • Cross-Species ADME & Metabolism
  • PK/PD & TK/TD Analysis

These services can be conducted as non-GLP or GLP studies.
In-house platforms include µHPLC, UPLC, high resolution/ accuracy (Q-TOF MS/MS) and sensitivity (API 6500s) mass spectrometry.

Selected Publications

  • Hsieh F, Tengstrand E. “Drug-Induced Phospholipidosis Assessment from Nonclinical to... Show more »

Nextcea, Inc. is a pharmaceutical service company dedicated to optimizing efficacy, minimizing toxicity, and ensuring the quality of drug products through all phases of drug development and biotherapeutic bioequivalence. Nextcea performs customized services in support of discovery, preclinical and clinical stage research and biological therapeutic development.

  • Biotherapeutic Antibody / Bioconjugate Characterization
  • Biomarkers
  • Drug-Induced Phospholipidosis
  • Analytical Method Development & Validation
  • Sample Analysis (non-GLP/GLP)
  • Cross-Species ADME & Metabolism
  • PK/PD & TK/TD Analysis

These services can be conducted as non-GLP or GLP studies.
In-house platforms include µHPLC, UPLC, high resolution/ accuracy (Q-TOF MS/MS) and sensitivity (API 6500s) mass spectrometry.

Selected Publications

  • Hsieh F, Tengstrand E. “Drug-Induced Phospholipidosis Assessment from Nonclinical to Clinical Studies” Dokusei Shitsumon-Bako, 17:24-36, 2015.
  • Liu N, Tengstrand EA, Chourb L, Hsieh FY “Di-22:6-BMP-bis(monoacylglycerol) phosphate: A clinical biomarker of drug-induced phospholipidosis for development and safety assessment” Toxicology and Applied Pharmacology. 279, 467-476, 2014.
  • Hsieh F. Tengstrand E. Detecting Phospholipidosis and Diagnosing Lysosomal Storage Disorders. US Patent 8,313,949 (2012) and Japanese Patent 5702363 (2015).
  • Tengstrand EA, Miwa GT, Hsieh FY “Bis(monoacylglycerol)phosphate as a non-invasive biomarker to monitor the onset and time-course of phospholipidosis with drug-induced toxicities”, Expert Opinion Drug Metabolism and Toxicology, 6(5):555-70, 2010.
  • Xu JJ, Kalgutkar AS, Will Y, Dykens J, Tengstrand E, Hsieh F. Hit and Lead Profiling: Identification and Optimization of Drug-like Molecules, Volume 43, Chapter 15. Predicting Drug-Induced Hepatotoxicity: In Vitro, In Silico and In Vivo Approaches. 2010.
  • Hsieh FY, Tengstrand E, Pekol TM, Guerciolini R, Miwa G. “Elucidation of Potential Bortezomib Response Markers in Multiple Myeloma Patients” Journal of Pharmaceutical and Biomedical Analysis 49(1):115-22, 2009.
  • Hsieh F., Tengstrand E, Li LY, Huang YN, Milton MN, Silverman L, Alden C, Miwa G, Lee F “Toxicological Protein Biomarker Analysis – An Investigative One-week Single Dose Intravenous Infusion Toxicity and Toxicokinetic Study in Cynomolgus Monkeys using and Antibody-cytotoxic Conjugate against Ovarian Cancer” Pharmaceutical Research, 25(6):1309-1317, 2008.
  • Drug safety evaluation through biomarker analysis—A toxicity study in the cynomolgus monkey using an antibody-cytotoxic conjugate against ovarian cancer. Frank Y. Hsieh, Elizabeth Tengstrand, Ju-Whei Lee, Lily Y. Li, Lee Silverman, Bill Riordan, Gerald Miwa, Mark Milton, Carl Alden, Frank Lee. Toxicology and Applied Pharmacology 224: 12-18, 2007.
  • Baronas E, Lee JW, Alden C, and Hsieh F “Biomarkers to Monitor Drug-Induced Phospholipidosis” Toxicology and Applied Pharmacology 218: 72-78, 2007.
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In vitro ADME
Price on request

Quantitative Assays using HPLC/UPLC and LC-MS/MS:

Nextcea develops and validates bioanalytical assays to support non-clinical and clinical analysis. We have the experience and state of the art platforms to accelerate pharmaceutical small and biotherapeutic analysis.

Quantitative Assays using HPLC/UPLC and LC-MS/MS:

Nextcea develops and validates bioanalytical assays to support non-clinical and clinical analysis. We have the experience and state of the art platforms to accelerate pharmaceutical small and biotherapeutic analysis.

  • Non-GLP
  • GLP Method Development
  • Method Validation
  • Sample Analysis
  • MetID cross species
  • In Vitro / In Vivo
  • Protein Binding
  • RBC Partitioning
  • Metabolic Stability
  • CYP Induction / Inhibition
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Clinical Laboratory Services
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*Drug-Induced Phospholipidosis
Drug-induced phospholipidosis (DIPL) is a phospholipid storage disorder characterized by an excessive accumulation of multi-lamellar bodies (myeloid bodies) in cells and tissues. Many drugs that cause DIPL are associated with clinical toxicities (myopathy, kidney injury, QT prolongation, lung... Show more »

*Drug-Induced Phospholipidosis
Drug-induced phospholipidosis (DIPL) is a phospholipid storage disorder characterized by an excessive accumulation of multi-lamellar bodies (myeloid bodies) in cells and tissues. Many drugs that cause DIPL are associated with clinical toxicities (myopathy, kidney injury, QT prolongation, lung injury, and hepatotoxicity). Because DIPL may be linked to unwanted toxicities, its presence during nonclinical/clinical testing can result in the delay or discontinuation of new drug development. DIPL should be carefully evaluated and interpreted on a case by case basis, especially for chronically used drugs. Read more

*Di-docosahexaenoyl (22:6)-BMP
The lysosomal phospholipid bis(mono)acylglycerol phosphate (BMP) is increased in the tissues of animals and humans with DIPL and the lysosomal storage disorder NPC disease. Elevated di‑docosahexaenoyl (22:6)-BMP (a unique isoform of BMP) in plasma and urine is a reliable indicator of tissue DIPL for nonclinical and clinical studies.

*DIPL Quantitative Assays
Nextcea specializes in DIPL bioassay services for nonclinical and clinical studies. We provide GLP validated bioanalytical
LC-MS/MS methods for measurement of di-22:6-BMP in animal and human matrices (plasma/serum, urine, tissues).

  • Nonclinical and clinical studies

  • Validated LC-MS/MS Assays

  • Non-GLP, GLP Study Sample Analysis

  • Correlate DIPL with PK/PD, TK/TD

*In Vitro DIPL Screening
The in vitro analysis of di-22:6-BMP provides a sensitive and specific high throughput screening assay to rapidly identify compounds with the potential to induce DIPL early in the drug discovery process.

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Biosimilar Assay Development
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*Characterization of Biotherapeutics
Nextcea’s scientists are experts in the complexities of large molecules and advanced, high resolution mass spectrometry based approaches for analysis of biotherapeutics.

  • Therapeutic antibodies (biosimilars, mAbs)

  • Antibody Drug Conjugates (ADCs)

  • Protein therapies

  • Gene... Show more »

*Characterization of Biotherapeutics
Nextcea’s scientists are experts in the complexities of large molecules and advanced, high resolution mass spectrometry based approaches for analysis of biotherapeutics.

  • Therapeutic antibodies (biosimilars, mAbs)

  • Antibody Drug Conjugates (ADCs)

  • Protein therapies

  • Gene therapies

In-house platforms include UPLC-MS and UPLC-MS/MS (API-6500s, high-resolution TripleTOF 6600). This enables the sponsor to select the best biologics candidate for each project for further development. Biotherapeutic services are tailored to the drug development needs of our sponsors.

*Biosimilar and Therapeutic Antibodies
- Demonstrate biosimilarity to a reference product

  • N-terminal heterogeneity: pyroglutamate . . .

  • Amino acid modifications: deamination, oxidation, glycanation

  • Fragmentation: Cleavage in the hinge region

  • Oligosaccharides: fucosylation, sialyation . . .

  • Disulfide bonds: free thiols, disulfide shuffling, thioether

  • C-terminal heterogeneity: proline amidation, lysine truncation

*Antibody Drug Conjugate (ADC)
- Number of toxins/drugs, variable drug-antibody ratio (DAR)

  • ADC DAR distribution impacting efficacy and PK/TK
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Biomarkers
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We identify early response markers in order to predict patient and animal response sooner and more non invasively compared to traditional clinical chemistry and morphological endpoints. Biomarker services are customized based on compound class and the drug development needs of our sponsors.

We identify early response markers in order to predict patient and animal response sooner and more non invasively compared to traditional clinical chemistry and morphological endpoints. Biomarker services are customized based on compound class and the drug development needs of our sponsors.

  • Define drug efficacy using biomarkers
  • Evaluate drug response sooner in animal disease models
  • Clinical response marker
  • Patient selection and stratification
  • Routine clinical care (companion diagnostic)

Mass spectrometry and bioinformatics are used to evaluate efficacy biomarkers and screen medicinal molecules based on drug efficacy responses. In-house platforms include HPLC/UPLC coupled to mass spectrometry LC-MS and LC-MS/MS (API-6500s, TripleTOF 6600).

  • Small and Large Molecule Bioanalysis
  • Method Development and Validation
  • Biomarker Discovery (Targeted, Non-targeted Approach)
  • Non-Clinical and Clinical Studies
  • Non-GLP, GLP Study Sample Analysis
  • PK/PD Correlation
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Drug Candidate Safety Testing
Price on request

The pharmaceutical industry continues to explore new methods to prevent costly and unforeseen safety issues during drug development. Biomarkers are increasingly viewed by the FDA as a means for providing toxicity information earlier in drug development. Safety biomarkers should be quantitative, highly specific, and sensitive in... Show more »

The pharmaceutical industry continues to explore new methods to prevent costly and unforeseen safety issues during drug development. Biomarkers are increasingly viewed by the FDA as a means for providing toxicity information earlier in drug development. Safety biomarkers should be quantitative, highly specific, and sensitive in order to provide insight into onset, severity, and recovery of toxicities. Nextcea specializes in the discovery, development, and GLP/non-GLP application of drug safety biomarkers to reduce late-stage drug attrition by guiding clinical development and meeting regulatory expectations.

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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
Price on request

Nextcea develops and validates bioanalytical assays to support non-clinical and clinical analysis. We have the experience and state of the art platforms to accelerate pharmaceutical small and biotherapeutic analysis.

  • Non-GLP

  • GLP Method Development

  • Method Validation

  • Sample Analysis

  • MetID cross species

-... Show more »

Nextcea develops and validates bioanalytical assays to support non-clinical and clinical analysis. We have the experience and state of the art platforms to accelerate pharmaceutical small and biotherapeutic analysis.

  • Non-GLP

  • GLP Method Development

  • Method Validation

  • Sample Analysis

  • MetID cross species

  • In Vitro / In Vivo

  • Protein Binding

  • RBC Partitioning

  • Metabolic Stability

  • CYP Induction / Inhibition

« Show less
In vivo PK/PD Studies
Price on request

Quantitative Assays using HPLC/UPLC and LC-MS/MS:

Nextcea develops and validates bioanalytical assays to support non-clinical and clinical analysis. We have the experience and state of the art platforms to accelerate pharmaceutical small and biotherapeutic analysis.

Quantitative Assays using HPLC/UPLC and LC-MS/MS:

Nextcea develops and validates bioanalytical assays to support non-clinical and clinical analysis. We have the experience and state of the art platforms to accelerate pharmaceutical small and biotherapeutic analysis.

  • Non-GLP
  • GLP Method Development
  • Method Validation
  • Sample Analysis
  • MetID cross species
  • In Vitro / In Vivo
  • Protein Binding
  • RBC Partitioning
  • Metabolic Stability
  • CYP Induction / Inhibition
« Show less
Bioavailability and Bioequivalence Studies
Price on request
Request a quote for more information about this service.
Pharmacology & Toxicology
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Bioanalysis
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Safety Pharmacology & Efficacy Testing
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