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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.

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development-lifecycle
formulation-development

Building a Strong Foundation for Product Development

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.

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.

Compatibility Studies

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

Benefits:


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


Possible incompatibilities:

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  • Physical: color change, eutectic formation, phase separation.

  • Chemical: hydrolysis, oxidation, reduction, precipitation, decarboxylation, racemization.

  • Thermal: interactions caused by heat during processing.


Common methods used:

 

  • Thermal studies: DSC, TGA.

  • Spectral methods: FTIR, X-Ray Diffraction.

  • Chromatography: HPLC.

  • Rheological: viscosity, flow properties.

Lead formulation optimization

  • 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 Identification

  • 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.

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 Identification

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.

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.

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.

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.

Specialized Services

SPECIALISED SERVICES

Clinical Labelling

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

HPAPI & 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.

Sterile Product Development

Aseptic fill-finish of vials/ syringes/ cartridges. Includes lyo cycle development, sterility, endotoxin, ICH stability, and regulatory CMC support.

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Dosage Form

Formulation Across Every Route of Administration

- Dosage Form Narratives

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.

Ophthalmic Formulations (Eye Drops, Ointments, Gels)

  •  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.

Injectables

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

Liquid Oral Formulations (Solutions, Suspensions, Syrups)

  • Designed to be stable, palatable, and bioavailable for pediatric, geriatric, and specialty care.

  • Address challenges of solubility, stability, and dispersion with optimized solvents and rheology modifiers.

  • Use taste-masking systems (flavors, sweeteners) for patient compliance.

  • Include preservative systems and ICH stability testing for microbial safety and shelf life.

  • End-to-end services: solubility screening, preservative efficacy, regulatory-ready development.

Otic Formulations (Ear Drops, Suspensions, Emulsions)

  • Focus on local efficacy, patient comfort, and long-term stability.

  • Optimize solubility, surfactants, and pH buffers for chemical integrity.

  • Use particle size and viscosity tuning for uniform dosing and retention.

  • Incorporate robust preservative systems for microbial safety.

  • Design for minimal irritation and sensory tolerance.

  • Services: pre-formulation, in-vitro testing, ICH stability, regulatory documentation.

Topical Formulations (Creams, Gels, Ointments)

  • 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.

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

Oral Film Formulations (Fast Dissolving Films)

  • Require precision in drug loading, taste masking, and rapid disintegration.

  • Ensure uniform API distribution in a thin, flexible polymer matrix.

  • Optimize taste, mouthfeel, and compliance with flavoring agents, sweeteners, and plasticizers.

  • Maintain consistent thickness, tensile strength, and content uniformity across batches.

  • Designed for pediatric and geriatric populations needing easy administration.

  • Supported by excipient screening, solvent casting, dissolution profiling, and regulatory documentation.

  • SmaBio Labs delivers safe, stable, scalable, and patient-friendly film solutions.

Solid Oral Formulations (Tablets, Capsules, Powders, Pellets)

  • Require precision in release design, bioavailability, and manufacturability.

  • Immediate-release: ensure rapid dissolution with excipient optimization, disintegration enhancers, and taste masking.

  • Sustained/Delayed/Controlled-release: involve polymer selection, matrix/coating technologies, and release kinetics.

Medical Food / Nutraceuticals

  • Develop low-nitrogen, protein-restricted, and keto-acid enriched formulations.

  • Balance nutritional needs, palatability, and stability for CKD patients.

  • Address challenges of GI tolerance, electrolyte balance, and metabolism.

  • Ensure compliance with stringent medical food regulations.

  • Deliver effective, safe, and compliant nutrition products tailored to kidney health.

Otic Formulations (Ear Drops, Suspensions, Emulsions)

  • Tailored to species-specific dosing, palatability, and absorption.

  • Formats include oral, injectable, topical, intramammary, and pour-ons.

  • Ensure stability under field-use environmental conditions.

  • Comply with regulatory requirements for companion and food-producing animals (withdrawal, residue limits).

  • Expertise in taste masking, controlled release, and global compliance.

  • Deliver safe, effective, and commercially viable veterinary products.

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