Welcome to Discovery Bioanalytical Consulting

At Discovery Bioanalytical Consulting, I specialize in providing tailored bioanalytical consulting services to biotechnology and pharmaceutical companies, as well as contract research organizations (CROs). As a bioanalytical experts, I am dedicated to helping you navigate the complexities of bioanalytical methods (PK, ADA, NAb, PD), ensuring your projects are not only successful but also compliant with industry standards. Let’s embark on this journey together and unlock the potential of your innovations.

Offerings

Expert Consultation

I bring you years of experience in bioanalytical method validation and implementation, and ensure you receive tailored advice that meets your product development phase-appropriate project needs.

Regulatory Compliance

I help navigate the complex landscape of regulatory requirements, ensuring your assays comply with the latest guidelines and standards in a phase appropriate manner.

BLA Assistance- ISI and 2.7.1

With over 50 BLA, sBLA, and NDA filings, I can provide editing, review, and writing of BLA section 2.7.1 and the Integrated Summary of Immunogenicity (ISI) documents.

Customized Solutions

Every project is unique. I offer customized solutions that align with your goals, timelines, and budget, ensuring optimal outcomes.

About Me

With over 20 years of demonstrated expertise in the Bioanalytical field, numerous technologies (LCMS, LBA/ELISA, Molecular-qPCR, ddPCR, dPCR, cell-based-NAb and IHC), leadership, strategy, cost-effectiveness, and over 15 previously approved biologics in my repertoire, I look forward to helping you bring your innovations forward from idea to approval. Let's begin moving your biologic forward together!

Frequently Asked Questions

What services does Discovery Bioanalytical Consulting offer?

I provide a range of bioanalytical consulting services tailored for biotechnology and pharmaceutical companies, as well as contract research organizations (CROs). My expertise includes method development, validation, IND and BLA submission (bioanalytical portions), and regulatory support to ensure your projects meet industry standards.

How can I get started with your consulting services?

Getting started is easy! Simply reach out to us through our contact form or give us a call. We'll schedule a consultation to discuss your specific needs and how we can assist you in achieving your goals.

What industries do you primarily work with?

I primarily work with biotechnology and pharmaceutical companies, as well as CROs. With my extensive experience in these sectors, I can provide specialized insights and solutions. I work with companies located in North America, Europe, and Asia.

What Modalities do you have experience with?

I work in a broad range of biologics. The list includes: Monoclonal Antibodies, Bispecific Antibodies, Enzymes, Antisense Oligonucleotides, Antibody-Drug Conjugates, Peptides, complex constructs, and Cell and Gene Therapy (CGT)including in vivo expressed biologics (including both LNP-mRNA and viral vectors) and CAR-T.

Approved Drug Program History

Molecule Proprietary Name Molecule Generic Name Molecule Type Indication Biological Target Role
Imfinzi Durvalumab mAb Oncology PD-L1 Bioanalytical Lead, Submission Lead, PK, ADA, and Nab Assay Lead, Outsourcing Lead
Enhertu trastuzumab-deruxtecan ADC Oncology HER2 Immunogenicity Lead, Submission Team, PK (LBA), ADA, and Nab Assay Lead, Outsourcing Lead, Co-Collaboration Lead
Imjudo Tremelimumab mAb Oncology CTLA4 Bioanalytical Lead, Submission Lead, PK, ADA, and Nab Assay Lead, Outsourcing Lead
Saphnelo Anifrolumab mAb SLE (Lupus) IFNar Bioanalytical Lead, Submission Lead, PK, ADA, and Nab Assay Lead, Outsourcing Lead
Beyfortus Nirsevimab mAb Infectious Disease RSV (F-protein) Bioanalytical Lead, Submission Lead, PK, ADA, and Nab Assay Lead, Outsourcing Lead
AiRuiKa Camrelizumab mAb Oncology PD-1 ISI Preparation
Evusheld AZD7442 (tixagevimab and cilgavimab) 2 mAbs COVID-19 COVID-19 Immunogenicity Strategy, Outsourcing Lead, ADA and Nab Assay Lead
Bydureon Bcise exenatide peptide T2DM GLP-1 Bioanalytical Lead, Submission Lead, ADA Assay Lead, Outsourcing Lead
Trulicity dulaglutide peptide T2DM GLP-1 Key Client Contact, PK Assay Lead
Kynamro Mipomersen, ISIS301012 ASO Hyper- cholesterolemia apoB-100 Key Client Contact, PK Assay Lead, ADA Assay Lead
Xigris drotrecogin alfa Enzyme Sepsis Activated Protein C Key Client Contact, PK Assay Lead, ADA Assay Lead, Nab Assay Lead
Mounjaro GIP-GLP peptide T2DM, Obesity GLP-1, GIP Key Client Contact, Discovery Bioanalysis PK Assay lead
Covishield, Vaxzevria ChAdOx1 vaccine COVID-19 COVID-19 Preclinical Strategy, molecular lead, DART study lead
Kisunla donanemab mAb Alheimer's Amyloid-beta Key Client Contact, PD Assay Lead
Cyramza ramucirumab mAb Oncology VEGFR2 Key Client Contact, PD Assay Lead

Let's talk!

Business Hours

Mon - Fri
-
Sat - Sun
Closed
5750 Prestwick Court, Discovery Bay, CA 94505-1406, US

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