Table of Content

Pharmaceutical Product Development

Merged Capabilities: From Concept to Commercialization

Overview

Development Lifecycle

Pre-Formulation Studies

Physicochemical analysis: Comprehensive evaluation of physicochemical properties including polymorphism, crystallinity, particle size, solubility across pH, hygroscopicity, bulk/tapped density, flow, and compatibility with excipients. Guides formulation and processability decisions.

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

Benefits: Accelerates formulation by eliminating incompatible excipients early; enhances product safety, stability, and shelf life; ensures regulatory compliance.
Possible incompatibilities:
- Physical: color change, eutectic formation, phase separation.
- Chemical: hydrolysis, oxidation, reduction, precipitation, decarboxylation, racemization.
- Thermal: interactions caused by heat during processing.
Common methods: DSC, TGA, FTIR, X-Ray Diffraction, HPLC, Rheological studies.

Formulation Development (QbD Driven)

Formulation Development

Proof-of-Concept (PoC) Batches

Define the final product’s desired characteristics (QTTP) and performance criteria (CQA).
Establish success criteria: quality, safety, stability, bioavailability, and efficacy.
Source high-quality raw materials (based on CMA of APIs and excipients).
Identify the processing framework: equipment, personnel, temperature, pressure, mixing speed, and timelines.
Evaluate PoC performance and present case studies with scalability protocols.
Manufacture prototype batches to validate PoC insights and ensure regulatory readiness.

Lead Formulation Identification

Identify one or two lead formulations from PoC that meet predefined QTTP.
Integrity: Establish safety and stability per formulation design.
Quality: Assess drug release, assay, content uniformity, and bioavailability.
Composition: Optimize excipient ratios, quantities, and attributes for robust, scalable products.
Stability: Conduct long-term and accelerated studies to confirm shelf life.
Packaging: Selection of primary and secondary packaging materials.

Lead Formulation Optimization

Develop optimal process parameters, identify stability risks, and define packaging/storage controls.
Scalability: Confirm formulation works at large-scale production.
Process: Define equipment and parameters, simulate scale-up, and ensure transferability.
Establish scientifically justified shelf life for compliance and market readiness.
Use systematic risk assessment and stress conditions to reveal stability issues on scale-up batches.

Process Identification & Optimization

Process Identification

Mapping process steps across dosage forms (blending, granulation, drying, milling, compression, coating, homogenization, sterilization, etc.). CPPs are identified and optimized.

Process Optimization (DoE & QbD)

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.

Stability Studies

ICH-compliant stability protocols across Zones I–IVb. Includes accelerated (40/75), long-term (25/60, 30/65, 30/75, 30/35) and photostability testing. Identifies degradation risks and confirms shelf life.

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 Optimization & Scale-Up

Pilot and engineering batches are executed to support scale-up and confirm process reproducibility.
CPPs and PARs are identified and challenged to evaluate process sensitivity under scale-relevant conditions.
Potential bottlenecks, operational inefficiencies, and process stress points are systematically assessed and mitigated.
Process validation activities are performed with defined in-process controls and monitoring strategies.

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.

Specialized Services

Batch Release Services: QC testing (HPLC, GC, spectroscopy), CoA issuance, cGMP-compliant release, inspection readiness.
Clinical Labeling: Blinded/unblinded labels, multi-language booklet, tamper-evident, QR/e-labels for clinical trials.
Stability Storage & Testing: ICH stability chambers (2–8 °C to ULT). Automated monitoring, tailored protocols.
HPAPI Formulation: Specialized containment, FFU/HEPA, safe handling SOPs, hormones/steroids expertise.
Aliquoting (cGMP): APIs, excipients, biologics aliquoted under cGMP. Traceable, secure, labeled, and logged.
Sterile Product Development: Aseptic fill-finish, lyo cycle development, sterility, endotoxin, ICH stability, and regulatory CMC support.

Dosage-Form Narratives

Dosage-Form

Transdermal Drug Delivery (Matrix Patches)

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.

Topical Formulations (Creams, Gels, Ointments)

Balance efficacy, texture, absorption, and skin safety using emulsifiers and penetration enhancers.
Ensure stability and non-irritancy through rigorous testing.
Optimize texture, spreadability, absorption, and release via careful excipient selection.

Ophthalmic Formulations (Drops, Ointments, Gels)

Tackle challenges of eye sensitivity, small surface area, and rapid clearance.
Control key parameters: pH, osmolality, viscosity, particle size.
Stabilize APIs against oxidation and hydrolysis; maintain clarity and preservative effectiveness.

Oral Film Formulations (Fast Dissolving)

Require precision in drug loading, taste masking, and rapid disintegration.
Ensure uniform API distribution in a thin, flexible polymer matrix.
Designed for pediatric and geriatric populations needing easy administration.

Injectables

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

Solid Oral Formulations (Tablets, Capsules, Pellets)

Immediate-release: Ensure rapid dissolution with excipient optimization and disintegration enhancers.
Sustained/Controlled-release: Involve polymer selection, matrix/coating technologies, and release kinetics.
Deliver high-quality IR and CR tablets and capsules ready for clinical and commercial success.

Liquid Oral Formulations

Designed to be stable, palatable, and bioavailable for pediatric and geriatric care. Addresses challenges of solubility and taste-masking (flavors, sweeteners).

Medical Food / Nutraceuticals (Renal-Focused)

Develop low-nitrogen, protein-restricted, and keto-acid enriched formulations.
Balance nutritional needs, palatability, and stability for CKD patients.
Ensure compliance with stringent medical food regulations.

Otic Formulations (Ear Drops)

Focus on local efficacy, patient comfort, and long-term stability. Optimize solubility, surfactants, and pH buffers for chemical integrity. Design for minimal irritation.

Veterinary Medicine

Tailored to species-specific dosing, palatability, and absorption. Formats include oral, injectable, topical, and intramammary. Comply with regulatory requirements for companion and food-producing animals.

CMC Services

CMC Services (Chemistry, Manufacturing & Controls)

Ensure consistent manufacturing, quality, and global compliance from preclinical to commercial.

Preformulation/Formulation Development: API characterization, excipient compatibility, IR/CR prototypes, stability.
Analytical Development/Validation: Stability-indicating methods, impurity profiling, tech transfer.
Process Development/Scale-Up: Optimize processes, tech transfer to GMP sites, PV planning.
Stability Studies: ICH/FDA-compliant accelerated and long-term testing.
Regulatory Documentation: Authoring CMC sections for IND, NDA, ANDA, 505(b)(2) with QbD-based justifications.
GMP Manufacturing Support: Support for CTM and commercial readiness. Coordination with CMOs/CROs to ensure audit readiness and quality oversight.