Product Development

Physicochemical analysis

Comprehensive evaluation of physicochemical properties: polymorphism, crystallinity, particle size, solubility across pH, hygroscopicity, bulk/tapped density, flow, and compatibility with excipients.

Compatibility Studies

Conducted during pre-formulation to identify and mitigate interactions impacting safety, stability, efficacy, or manufacturability.

Benefits include:

• Accelerating formulation by eliminating incompatible excipients early.
• Enhancing product safety, stability, and shelf life.
• Ensuring compliance with regulatory guidelines.

Possible incompatibilities

• Physical: color change, eutectic formation, phase separation.
• Chemical: hydrolysis, oxidation, reduction, precipitation, decarboxylation, racemization.
• Thermal: interactions caused by heat during processing.

Example of Common methods used

• Thermal studies: DSC, TGA.
• Spectral methods: FTIR, X-Ray Diffraction.
• Chromatography: HPLC.
• Rheological: viscosity, flow properties.

Proof-of-Concept (PoC) Batches

• Define the final product’s desired characteristics, Quality Target Product Profile (QTTP) and performance criteria, Critical Quality Attribute (CQA).
• Establish success criteria: quality, safety, stability, bioavailability, and efficacy.
• Source high-quality raw materials (based on Critical Material Attributes (CMA) of APIs and excipients) that influence final product quality.
• Identify the processing framework: through DoE equipment, temperature, pressure, mixing speed, and timelines.
• Evaluate PoC performance across safety, stability, bioavailability, and efficacy.
• Present case studies with scalability protocols, key pain points, and mitigation strategies or alternatives.
• Manufacture prototype batches to validate PoC insights and ensure regulatory readiness.

Lead Formulation Identification

• Identify one or two lead formulation from POC that meets predefined QTTP and CQA’s
• Integrity: Establish safety and stability per formulation design.
• Quality: Assess drug release, assay, content uniformity, and bioavailability.
• Define excipient selection and ratio ranges (DoE as needed) to deliver robust performance and scale-up feasibility.
• Stability: Conduct long-term and accelerated studies to confirm shelf life.
• Packaging: selection of primary and secondary packaging materials

Lead formulation optimization

• Develops optimal process parameters, identifies stability risks, and defines packaging/storage controls.
• Scalability: Confirm formulation works at large-scale production.
• Process: Define equipment and parameters, simulate scale-up, and ensure transferability. Establishes scientifically justified shelf life for compliance and market readiness.
• Use systematic risk assessment and stress conditions to reveal stability issues on scale up batches.
• Apply mitigation strategies to ensure reliable performance across ICH climatic zones.

Stability Studies

• Identifies degradation risks and confirms shelf life.
• 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

Evaluation of moisture, oxygen, light barriers; migration, leachable, seal integrity, physical strength, compatibility with formulation. Includes accelerated and real-time validation studies.

Process Identification

• Mapping process steps across dosage forms:
• Homogenization, sterilization (liquids).
• Aseptic fill/lyo (sterile product).
• Coating, drying and converting (Transdermal patches).
• Blending, granulation, drying, milling, compression, coating (solid orals).
• CPPs identified and optimized.

Process Optimization (Lab Scale)

A systematic DoE- and QbD-based approach is used to refine and control manufacturing processes.

• Mapping unit operations across the full process flow
• Identifying Critical Process Parameters (CPPs) that have a direct impact on CQAs
• Defining Process Analytical Requirements (PARs) to monitor and control CPPs
• Establishing process boundaries, operating ranges, and interactions
• Linking material attributes, process parameters, and CQAs through scientific rationale

Process 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.

• GMP-compliant CTM for Phase I–II. Manufactured in classified cleanrooms. Includes analytical validation, warehouse control, and support for IND, NDA, ANDA, 505(b)(2) filings.

Clinical Packaging and Labeling

Blinded/unblinded labels, multi-language booklet, tamper-evident, QR/e-labels for clinical trials.

HPAPI Formulation and Potent API handling

Specialized containment, FFU/HEPA, safe handling SOPs, hormones/steroids expertise, and analytical validation.

Aliquoting (cGMP)

APIs, excipients, biologics aliquoted under cGMP. Traceable, secure, labeled, and logged for clinical supply.

Ophthalmic Formulations (Eye Drops, Ointments, Gels)

• Tackle challenges of eye sensitivity, small surface area, and rapid clearance.
• Ensure sterility, non-irritation, and physiological compatibility.
• Control key parameters: pH, osmolality, viscosity, particle size.
• Stabilize APIs against oxidation and hydrolysis for long-term efficacy.
• Maintain clarity, preservative effectiveness, and microbial safety.
• Expertise in aseptic formulation, ICH stability, and preservative testing.
• Use advanced analytics: in-vitro release, clarity, and particulate testing.
• Develop solutions, suspensions, ointment and gels ready for clinical and commercial success.

Sterile Formulation

• Solutions, suspensions, emulsions, lyophilized products. Requires sterility, solubility optimization, stability, endotoxin/pH/osmolality control. Includes aseptic processing, container closure compatibility, regulatory support.

Topical Formulations (Creams, Gels, Ointments)

SmaBio Labs delivers stable, patient-friendly formulations from concept to commercial readiness.

• Balance of efficacy, texture, absorption, and skin safety.
• Use emulsifiers, gelling agents, and penetration enhancers for optimal performance.
• Ensure stability and non-irritancy through rigorous testing.
• APIs must reach the target skin layer while maintaining potency and avoiding degradation.
• Optimize texture, spreadability, absorption, and release via careful excipient selection.

Transdermal drug delivery (Matrix Patches)

Transdermal patch development demands precision—from drug selection to skin compatibility. At SmaBio Labs, we turn complexity into patient-friendly, stable, and scalable solutions.

• Overcome skin’s natural barrier while ensuring stability and patient comfort.
• Select drugs with optimal properties: low molecular weight, lipophilicity, and potency.
• Design matrix polymers, adhesives, and enhancers for consistent drug release.
• Minimize risks of skin irritation and sensitization, even with long-term use.
• Expertise in excipient screening, in-vitro permeation, and stability optimization.
• End-to-end support for safe, scalable, and patient-friendly transdermal patch development.