From chemistry to clinic
Connect molecule characterization, formulation development and clinical trial material requirements around your product and next milestone.
COMPLEX DRUG PRODUCTS & COMBINATION SYSTEMSFormulation science.
Formulation science.
Analytical insight.
Develop and characterize complex drug products through pre-formulation studies, QbD-driven formulation, analytical testing and phase-appropriate clinical manufacturing.
FDA-registeredAnalytical laboratory
Phase I–IIClinical trial material manufacturing
Small & large moleculesAnalytical service capabilities
WHY SMABIO LABS
Scientific depth. A connected partnership.
Bring analytical science, formulation development and clinical material needs into one focused technical conversation.
A focused start to your program
Plan for kickoff within two weeks of contract execution, subject to current capacity, agreed prerequisites and program requirements.
A direct scientific conversation
Discuss methods, technical challenges and development decisions with the scientific team supporting your program.
Quality you can examine
Successful client audits are part of our quality credentials. Review the documentation, audit requirements and oversight relevant to your program.
CHARACTERIZE. FORMULATE. EVALUATE.
Find a scientific starting point.
Select your material, development stage and immediate question. Suggestions help frame a technical conversation; suitability and scope require review.
FRAME YOUR SCIENTIFIC CHALLENGE
Start with the question you need to resolve.
Understand an impurity
Frame the analytical question, available evidence and characterization needs.
Small-Molecule Analytical ServicesCustom SynthesisDiscuss this questionInvestigate instability
Discuss observed change, study conditions and appropriate analytical endpoints.
Stability Storage & TestingSmall-Molecule Analytical ServicesBiologics Analytical ServicesDiscuss this questionImprove a formulation
Explore how composition and process variables relate to target product attributes.
Product DevelopmentDiscuss this questionAssess an analytical method
Review intended use, method documentation, sample matrix and transfer requirements.
Small-Molecule Analytical ServicesBiologics Analytical ServicesDiscuss this questionTHE SCIENCE BEHIND THE SERVICE
Capabilities you can examine.
Explore the methods, dosage forms and scientific disciplines relevant to your product.
01
FORMULATE
Product Development
Pre-formulation, formulation and process development for complex drug products and combination systems.
02
CHARACTERIZE
Small-Molecule Analytical Services
Analytical development, characterization and testing for drug substance, drug product and related materials.
03
CHARACTERIZE
Biologics Analytical Services
Structural, purity and heterogeneity analysis for ADCs, proteins and polypeptides.
04
EVALUATE
Stability Storage & Testing
Study design, storage and analytical testing to understand product change over time.
05
CLINICAL SUPPLY
Clinical Trial Material Manufacturing
Sterile and non-sterile clinical trial material support from preclinical development through Phase I and Phase II.
06
CHEMISTRY
Drug Discovery & Process Development
Discovery and process chemistry connecting early research with API and intermediate development.
07
CHEMISTRY
Custom Synthesis
Synthesis support for API intermediates, reference standards and impurities.
CAPABILITY FACTSHEETS
Product development, in a clearer view.
Explore the connected development disciplines in our redesigned capability factsheet.
A QbD-DRIVEN DEVELOPMENT APPROACH
Decisions grounded in product understanding.
Engage for an individual service or connect disciplines around a broader development program.
Characterize the material.
Understand physicochemical properties and drug–excipient compatibility. Define the target product profile and critical quality attributes.
INFORMSCharacterization findings and formulation considerations
Evaluate the possibilities.
Develop proof-of-concept batches, evaluate lead formulations and examine packaging compatibility. Apply design of experiments where appropriate.
INFORMSFormulation assessment and selection rationale
Understand the process.
Map unit operations, equipment requirements and parameters that influence product quality and reproducibility.
INFORMSProcess understanding and control considerations
Build the evidence.
Evaluate scale-up considerations, control strategies and stability to inform the next development decision.
INFORMSStability findings and scale-up assessment
PEOPLE BEHIND THE SCIENCE
Scientific and quality leadership.
Lakshmidevi Ethirajan, PhD
CEO / Co-FounderScientific responsibility
Leads company vision, growth strategy and overall operational excellence.
Sachin Pandit, PhD
Associate Vice President, OperationsScientific responsibility
Manages technical operations, process workflows and execution of scientific projects.
Yide Chang, PhD
Director of Analytical ServicesScientific responsibility
Oversees analytical operations and the development of robust analytical methods.
Murugu Swaminathan, MS, MBA
Site Quality Head ConsultantScientific responsibility
Pharmaceutical quality leader with more than 25 years across pharmaceutical, biotechnology and CDMO organizations. Provides oversight of site quality, quality systems and inspection readiness.
SCIENTIFIC RESOURCES
Start with a better-informed conversation.
CAPABILITY GUIDE
Scientific capability overview
Explore the scientific services relevant to your product, connect them to the decision you need to make and prepare a focused brief for technical review.
Read the guide PROJECT PREPARATIONPlanning a stability discussion
Information to bring when discussing a product-specific stability program. Use this guide to clarify the decision, organize the available evidence and prepare a focused technical brief.
Read the guide PROJECT PREPARATIONStarting a formulation program
Prepare a focused formulation discussion by clarifying the target product, organizing the existing evidence and identifying the decision your next development work should support.
Read the guideA TECHNICAL CONVERSATION STARTS HERETell us what your
Tell us what your
product needs to do.
Share your product, scientific challenge and next milestone. Request an NDA before providing proprietary details.