Product Development
Integrated Product Development for Complex Drug Products and Combination Systems delivering the formulation expertise needed to advance drug products from pre-clinical development through clinical evaluation and regulatory submission.
SmaBio Labs provides product development support for complex and conventional dosage forms, including ophthalmic products, long-acting injectables, transdermal systems, microneedles, drug-device combination products, and standard formulations. Our scientists work as an extension of our partners' teams to design and optimize formulations aligned with defined development objectives. Through a collaborative, science-driven approach, we help partners navigate development challenges and generate the data and understanding needed to advance programs toward clinical success and support efficient regulatory submissions.
Designing Formulations for Success
Pre-Formulation: Physicochemical Analysis
Comprehensive evaluation of physicochemical properties: polymorphism, crystallinity, particle size, solubility across pH, hygroscopicity, bulk/tapped density, flow, and compatibility with excipients.
Lead Formulation
From Optimization to Identification
Systematic optimization and identification of lead formulations meeting predefined QTTP and CQAs, with scalability and shelf-life verified.
Extractables and Leachables (E&L)
Lead Formulation Identification
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Develops optimal process parameters, identifies stability risks, and defines packaging/storage controls.
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Scalability: Confirm formulation works at large-scale production.
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Process: Define equipment and parameters, simulate scale-up, and ensure transferability. Establishes scientifically justified shelf life for compliance and market readiness.
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Use systematic risk assessment and stress conditions to reveal stability issues on scale up batches.
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Apply mitigation strategies to ensure reliable performance across ICH climatic zones.
Extractables and Leachables (E&L)
Lead formulation optimization
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Identify one or two lead formulation from POC that meets predefined QTTP and CQA’s
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Integrity: Establish safety and stability per formulation design.
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Quality: Assess drug release, assay, content uniformity, and bioavailability.
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Define excipient selection and ratio ranges (DoE as needed) to deliver robust performance and scale-up feasibility.
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Stability: Conduct long-term and accelerated studies to confirm shelf life.
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Packaging: selection of primary and secondary packaging materials
02 · Process Development & Optimization
DoE-Driven Process Development
Process Optimization & Scale-Up
Pilot and engineering batches are executed to support scale-up and confirm process reproducibility. Critical Process Parameters (CPPs) and Process Attribute Ranges (PARs) are identified and challenged to evaluate process sensitivity under scale-relevant conditions.
Potential bottlenecks, operational inefficiencies, and process stress points (e.g., mixing, heat transfer, hold times, filtration, and transfer steps) are systematically assessed and mitigated.
Process validation activities are performed with defined in-process controls and monitoring strategies to demonstrate process robustness, consistency, and readiness for commercial manufacturing and market supply.
Process Identification
Process Identification
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Mapping process steps across dosage forms: blending, granulation, drying, milling, compression, coating (solid orals); homogenization, sterilization (liquids); aseptic fill/lyo (sterile product) Transdermal patches (coating, drying and converting), CPPs identified and optimized.
SPECIALISED SERVICES
01 Clinical Labelling
02 HPAPI & Potent API Handling
03 Aliquoting (cGMP)
04 Sterile Product Development
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Clinical Labelling
• Blinded/unblinded labels, multi-language booklet, tamper-evident, QR/e-labels for clinical trials.
0 3 · Stability , Packaging & Scale - Up
From Pilot Batches to
Commercial Readiness
Stability Studies
Stability Studies
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Identifies degradation risks and confirms shelf life.
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ICH-compliant stability protocols across Zones I–IVb. Includes accelerated (40/75), long-term (25/60) and Intermediate (30/65) and photostability testing.
Packaging Material Selection
Packaging Material Selection
Evaluation of moisture, oxygen, light barriers; migration, leachable, seal integrity, physical strength, compatibility with formulation. Includes accelerated and real-time validation studies.
Preclinical and Clinical Trial Material Manufacturing
Preclinical and Clinical Trial Material Manufacturing
GMP-compliant CTM for Phase I–II. Manufactured in ISO-8 cleanrooms. Includes analytical validation, warehouse control, and support for IND, NDA, ANDA, 505(b)(2) filings.