Services We Offer

Analytical and Formulation Solutions for Biopharma

Characterization
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Characterization

We have successfully supported our clients with comprehensive characterization packages for IND, CTA, MAA, and BLA filings.

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Compliance
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Compliance

Quality Management System (QMS) and 21 CFR Part 11 compliant software packages ensure us providing services for analytical method qualification and validation, comparability studies at different stages for our clients.

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High-End Analyses
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High-End Analyses

We are the experts on high-end and challenging analysis of SVA, HCP, disulfide and trisulfide bond isoforms, unknow impurities structural elucidation, and cell-based assays.

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Formulation Development
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Formulation Development

We have extensive experience on liquid, frozen, and lyophilization development including formulation screening, stress stability studies, and formulation evaluations with a full panel of analytical assays.

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LEADING THE WAY IN BIOPHARMA CROs WITH

Cutting-Edge Technologies

Mass Spectrometry

We are the industry leader in MAM and other MS technologies for HCP, SVA, intact mass, disulfide shuffling, glycosylation, and other CQAs analysis.

LC and CE

Conduct cIEF, CE-SDS, SEC, reverse phase, affinity, IEX & fraction collection followed by in-depth analysis for comprehensive profiling.

Biophysical Characterization

Employ UVCD, DSC, DLS, SEC-MALS, & fluorescence spectroscopy to thoroughly characterize biophysical properties.

Particulate Analyses

Utilize HIAC, MFI, Flow Imaging Microscopy (FIM) technologies to accurately analyze & quantify particulates, ensuring product purity and safety.

Cell Based Assays

Offer apoptosis-proliferation, cytotoxicity, ADCC, immune checkpoint functional, chemotaxis/cell migration, functional lentiviral vector infectivity/titer assays.

Formulation Development

Leverage our extensive experience in frozen, liquid and lyophilization formulation development for formulation screening, stress stability studies, and PQA analysis.

EQUIPPED FOR EXCELLENCE WITH

Top-Tier Laboratory Infrastructure

Our modern labs use cutting-edge technology to ensure precise and reliable results. We meet the highest standards, supporting advanced biopharma research and development

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MEET THE FOUNDER

The Mind Behind Our Success

Dr. Da Ren
Welcome to Bio Therapeutics Solutions

As the founder & CEO, I am honored to share our mission of providing top-quality, cost-effective analytical solutions for the biopharma industry. With a background in pioneering the Analytical Platform and MAM at a major biopharma company, I have dedicated my career to advancing analytical excellence.

Our advanced technologies & expert team ensure precision and reliability in every project. We are committed to driving innovation and helping our clients to achieve their goals.

Thank you for trusting BioTherapeutics Solutions as your partner!

HEAR FROM OUR CLIENTS

Testimonials

“I would like to share with you the good news. Our very first peptide program was moving to clinical trial. The data you generated for the confirmation of the sequence and identification of the major degradant were part of the CTA submission. Thanks for your effort and your expertise contributing to our success!”

Principle Scientist
a mid-size biopharma company in USA

"The in-depth characterization package your firm provided for us is comprehensive. The BLA filing for the program was successful and we didn't receive any RTQ on the characterization section. Thank you for providing high quality analytical services for our product!"

Director
a large biopharma company in USA

STAY INFORMED WITH

BioTherapeutics Solutions Industry Presence

2025 WCBP
2025 WCBP, Jan 28, 2025
PANELIST: Hidden Potential of Established Analytical Technologies Session
PANELIST: Navigating the Small and Virtual Business Landscape Session

Analytical Control Strategy for Biologics. Part I: Foundations
J. Pharm Sci. (2025) 114(7):103826, Kendrick B. S., Sampathkumar K., Gabrielson J. P., Ren D.

Analytical Control Strategy for Biologics. Part II: Roadmap for Development and Implementation
J. Pharm Sci. (2025) 114(8):103834, Sampathkumar K., Kendrick B. S., Gabrielson J.P., Ren D.

Comprehensive multi-attribute method (MAM) workflow for biotherapeutic characterization and cGMP testing
Nat. Protoc. (2023) 8(4):1056-1089, Bones J., Millan-Martin S., Carillo S., Jakes C., Ren D., Rogers R.S.

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Ready to Elevate Your Biopharma Projects?

Reach Out to Us Today for Expert Solutions!

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