OUR CAPABILITIES

Solubility Enhancement Technologies

Many promising drug candidates face poor water solubility challenges, limiting their bioavailability. Our QbD-driven solubility enhancement solutions include:

• Amorphous Solid Dispersions (ASDs) – Enhancing solubility using polymer-based dispersion technology.
• Self-Emulsifying Drug Delivery Systems (SEDDS & SMEDDS) – Formulating lipid-based emulsions to improve oral bioavailability.
• Nanocrystal Technology – Reducing particle size to increase dissolution rate and absorption.
• Cyclodextrin Complexation – Enhancing drug solubility and stability through inclusion complex formation.
• Co-Crystal Technology – Modifying API crystalline structure for better solubility and stability.

Lipid Nanoparticles (LNPs) for Nucleic Acid Delivery

We specialize in the QbD-based design and formulation of lipid nanoparticles (LNPs) for targeted delivery of mRNA, siRNA, and DNA-based therapeutics. Our expertise includes optimizing lipid selection, encapsulation efficiency, and stability to ensure effective intracellular delivery and enhanced bioavailability.

Solubility Enhancement Technologies

Many promising drug candidates face poor water solubility challenges, limiting their bioavailability. Our QbD-driven solubility enhancement solutions include:

• Amorphous Solid Dispersions (ASDs) – Enhancing solubility using polymer-based dispersion technology.
• Self-Emulsifying Drug Delivery Systems (SEDDS & SMEDDS) – Formulating lipid-based emulsions to improve oral bioavailability.
• Nanocrystal Technology – Reducing particle size to increase dissolution rate and absorption.
• Cyclodextrin Complexation – Enhancing drug solubility and stability through inclusion complex formation.
• Co-Crystal Technology – Modifying API crystalline structure for better solubility and stability.

High Potency APIs (HPAPIs)

High Potency Active Pharmaceutical Ingredients (HPAPIs) require specialized containment, handling, and formulation strategies to ensure safety, efficacy, and regulatory compliance. These compounds, often used in oncology, hormonal therapies, and targeted treatments, pose significant challenges due to their high pharmacological activity at low doses.

• Containment & Safety – We develop GMP-compliant containment strategies, including isolators, closed processing systems, and advanced air filtration to minimize occupational exposure risks.
• QbD-Driven Formulation Development – Our team optimizes micronization, nano-milling, and encapsulation techniques to enhance bioavailability while maintaining dose uniformity.
• Solubility & Stability Enhancement – Many HPAPIs suffer from poor solubility and stability issues. We leverage solid dispersions, lipid-based delivery, and nanoformulation approaches to enhance therapeutic performance.
• Targeted Drug Delivery – We integrate HPAPIs into liposomal, polymeric micelle, and antibody-drug conjugate (ADC) formulations for site-specific targeting and reduced systemic toxicity.
• Regulatory & Scale-Up Expertise – Our regulatory team ensures compliance with ICH, FDA, and EMA guidelines, providing support for CMC documentation, risk assessments, and process validation.

Long-Acting Injectables (LAIs)

We develop QbD-optimized long-acting injectable formulations for sustained drug release, improving patient adherence and therapeutic efficacy. Our capabilities include:

• Microparticles (PLGA, Polymeric Microspheres) – Controlled drug release via biodegradable microspheres.
• Liposomes – Lipid vesicle formulations for targeted and sustained drug delivery.
• In Situ Forming Gels – Injectable biodegradable gels that solidify in vivo for controlled release.
• Oil-Based Solutions & Suspensions – Lipid-based depot formulations for extended release.
• Nanoparticles – Polymeric and lipid nanoparticles designed for enhanced bioavailability and prolonged circulation.

Cell Therapy

Cell-based therapies, including CAR-T, stem cell, and regenerative medicine applications, require precision process development, cryopreservation, and scalable manufacturing to ensure cell viability and therapeutic success. Our QbD-driven approach optimizes cell culture conditions, expansion, and delivery methods to improve treatment outcomes.

• Process Development & Optimization – We establish robust upstream and downstream processes, optimizing cell selection, expansion, and differentiation while maintaining functional potency.
• Scalable Manufacturing – Our team develops GMP-compliant closed-system manufacturing solutions for autologous and allogeneic cell therapies, ensuring process consistency and regulatory alignment.
• Cryopreservation & Stability – We optimize cryoprotectants, freeze-drying, and controlled thawing protocols to preserve cell viability and function post-thaw.
• Delivery & Formulation Technologies – To improve cell survival and targeting, we develop hydrogel encapsulation, scaffold-based delivery, and nanoparticle-assisted cell transport systems.
• Regulatory & Compliance Support – Cell therapies require complex regulatory submissions. We assist in IND/BLA preparation, assay validation, and release testing, ensuring alignment with FDA, EMA, and PMDA requirements.

Gene Therapy

Gene therapy is revolutionizing medicine, offering curative treatments for genetic disorders, cancers, and rare diseases. We provide comprehensive support in vector design, formulation optimization, and commercial-scale production, ensuring safety, efficacy, and regulatory compliance.

• Viral & Non-Viral Vector Design – We develop AAV, lentivirus, and adenovirus-based gene delivery systems, optimizing vector stability, transduction efficiency, and immune evasion strategies.
• Lipid Nanoparticle (LNP)-Based Gene Delivery – Our expertise in LNP formulations ensures high mRNA encapsulation efficiency, enabling safe, effective intracellular delivery for mRNA vaccines and gene-editing therapies.
• Process Development & Scalability – We establish scalable upstream and downstream manufacturing processes for clinical and commercial production, optimizing vector yield and purity.
• CRISPR & RNA-Based Therapeutics – We support gene-editing technologies by enhancing CRISPR-Cas9 delivery, ensuring precise genome modifications for therapeutic applications.
• Regulatory & Analytical Characterization – Our regulatory experts ensure compliance with ICH Q5A/B, FDA gene therapy guidance, and ATMP (Advanced Therapy Medicinal Product) regulations, supporting IND/BLA filings and post-market surveillance.

Oligonucleotide-Based Therapeutics

Oligonucleotide therapeutics, including siRNA, antisense, and mRNA-based drugs, represent a rapidly evolving class of therapies with unique formulation and delivery challenges. Our QbD-driven formulation strategies enhance stability, targeting, and controlled release.

• Delivery Optimization – We develop lipid nanoparticles (LNPs), polymeric carriers, and conjugation strategies to ensure efficient intracellular delivery and minimize degradation.
• mRNA & Antisense Oligonucleotides (ASOs) – Our team optimizes stabilization, chemical modifications, and exon-skipping strategies to enhance mRNA translation and antisense efficacy.
• siRNA & RNA Interference (RNAi) Therapies – We specialize in formulating siRNA-based therapies using cationic lipids, exosome-based carriers, and polymeric nanoparticles for precise gene silencing applications.
• Chemical Modifications & Stabilization – We employ 2'-O-methylation, phosphorothioate backbones, and locked nucleic acids (LNAs) to enhance oligonucleotide stability and reduce off-target effects.
• Scalable Manufacturing & Regulatory Support – Our expertise in oligonucleotide synthesis, purification, and CMC documentation ensures GMP-compliant large-scale production aligned with FDA and EMA regulatory frameworks.

Peptides & Proteins

Peptides and protein-based drugs play a crucial role in oncology, metabolic disorders, and immunotherapy, but present unique challenges in formulation, stability, and bioavailability. We specialize in QbD-driven strategies to overcome these hurdles while maintaining therapeutic efficacy.

• Stabilization & Degradation Prevention – Peptides and proteins are prone to aggregation, oxidation, and enzymatic degradation. We utilize freeze-drying (lyophilization), PEGylation, and encapsulation in biodegradable polymers to enhance stability and shelf-life.
• Enhanced Bioavailability & Targeted Delivery – To improve oral, parenteral, and transdermal peptide delivery, we develop lipid-based nanoparticles, hydrogels, and depot formulations for controlled and sustained release.
• Solubility & Permeability Optimization – Many peptides face low solubility and poor membrane permeability. We employ self-emulsifying drug delivery systems (SEDDS), carrier-based transporters, and cell-penetrating peptides (CPPs) to improve absorption.
• Injectable & Alternative Routes of Administration – While injectables remain the primary delivery route, we develop oral, intranasal, and pulmonary delivery systems to enhance patient compliance.
• CMC & Manufacturing Support – Our expertise in peptide purification, recombinant protein production, and analytical characterization ensures scalability and regulatory compliance across different platforms.

Advanced & Targeted Drug Delivery Technologies

At InnoTech BioPharm Solutions LLC, we specialize in QbD-driven advanced drug delivery technologies to enhance bioavailability, improve therapeutic efficacy, and ensure patient compliance. Our expertise spans multiple modified-release, targeted, and site-specific drug delivery systems, integrating AI-driven optimization, predictive modeling, and scalable manufacturing to streamline development and commercialization.
Coated CR/SR/ER/TR/DR Pellets
Controlled-Release (CR), Sustained-Release (SR), Extended-Release (ER), Time-Release (TR), and Delayed-Release (DR) coated pellets allow for precise drug release control, enhancing absorption, therapeutic performance, and patient adherence. These multi-layered pellet systems provide customizable drug release kinetics by modulating polymer coating thickness, solubility, and permeability.

• QbD-Based Formulation Optimization – Our team designs multi-functional coating layers using ethyl cellulose, Eudragit®, and enteric polymers to achieve pH-dependent or time-controlled drug release.
• Dual or Pulsatile Drug Release Profiles – Coated pellet formulations allow for bimodal or pulsatile drug release, enabling morning and evening dosing regimens for chronic disease management.
• Gastrointestinal Targeting – We optimize pH-responsive coatings to ensure site-specific drug release in the stomach, small intestine, or colon, enhancing efficacy while minimizing systemic side effects.
• Improved Stability & Flow Properties – Pelletization enhances powder flowability, uniform drug distribution, and moisture protection, making these formulations ideal for capsules, sachets, or compressed tablets.
• Scalability & Manufacturing Expertise – Our advanced fluid bed coating, spray drying, and extrusion-spheronization techniques ensure GMP-compliant large-scale production with batch-to-batch consistency.

Spray Congealed Pellets

Spray congealing (melt granulation) is a solvent-free technology that forms lipid-based, controlled-release drug pellets with enhanced stability, moisture resistance, and bioavailability. This technique is highly effective for encapsulating poorly water-soluble drugs, stabilizing peptides/proteins, and taste-masking applications.

• Solvent-Free Processing – Unlike traditional wet granulation, spray congealing eliminates solvent-related degradation risks, improving the chemical and physical stability of APIs.
• Customizable Drug Release – By adjusting lipid composition, polymer ratios, and cooling conditions, we design immediate, sustained, or delayed-release formulations tailored to specific therapeutic needs.
• Moisture-Sensitive API Protection – Hydrophobic lipid coatings shield drugs from humidity, hydrolysis, and oxidation, extending shelf life and formulation robustness.
• Enhanced Palatability & Patient Compliance – Spray congealed pellets offer superior taste masking, making them ideal for pediatric and geriatric formulations requiring better patient acceptance.
• Seamless Scale-Up for Commercialization – Our expertise in fluidized-bed cooling and precision spray nozzle technologies ensures high reproducibility and efficiency in large-scale GMP manufacturing.

Ocular Drug Delivery

Ophthalmic drug delivery requires precise formulation strategies to maximize drug absorption, prolong residence time, and ensure sustained therapeutic action. We develop nanoparticles, in situ gels, and bioerodible implants for targeted drug release in anterior and posterior ocular tissues.

• Nanoparticle-Based Ophthalmic Formulations – We formulate lipid nanoparticles (LNPs), polymeric micelles, and dendrimers to enhance corneal permeability and drug retention.
• In Situ Forming Gels – Temperature-sensitive or pH-responsive liquid-to-gel systems enable prolonged drug retention on the ocular surface, reducing frequent dosing requirements.
• Bioerodible Implants & Microparticles – Sustained-release intravitreal implants (e.g., PLGA-based or biodegradable polymer implants) ensure months-long therapeutic coverage for retinal disorders.
• Mucoadhesive Drug Delivery – We optimize mucoadhesive nanoparticles and polymer-based ocular films to improve drug absorption and retention time for glaucoma, uveitis, and dry eye syndrome treatments.
• Regulatory Compliance & Scale-Up – Our team ensures FDA, EMA, and ICH regulatory alignment for ophthalmic formulations, supporting clinical trials and commercial manufacturing.

Topical & Transdermal Drug Delivery

Topical and transdermal drug delivery systems offer localized or systemic drug absorption, ensuring sustained release, improved bioavailability, and enhanced patient compliance. We develop nanoemulsions, liposomal gels, and microneedle-based platforms for dermal, transdermal, and cosmetic applications.

• Liposomal & Nanoemulsion-Based Drug Delivery – We utilize lipid-based vesicles and nanoemulsions to enhance skin penetration and sustained drug release, improving dermal bioavailability.
• Microneedle Patches for Pain-Free Delivery – Our expertise in dissolving, coated, and polymeric microneedle technology allows for non-invasive systemic drug absorption, reducing first-pass metabolism effects.
• Hydrogel-Based Drug Carriers – Biopolymer hydrogels improve moisturization, skin adherence, and controlled release for dermatology and pain management applications.
• Transdermal Patches & Films – We design permeation-enhanced transdermal patches, integrating iontophoresis, electroporation, and ultrasound-assisted drug delivery for higher systemic absorption.
• Regulatory Support & Commercial Scale-Up – Our team ensures cGMP-compliant manufacturing of topical/transdermal formulations, meeting global regulatory requirements.

CR/ER/DR Suspensions

Controlled-Release (CR), Extended-Release (ER), and Delayed-Release (DR) suspensions provide modulated drug absorption in liquid dosage forms, ensuring better dosing flexibility and patient compliance. These are particularly beneficial for pediatric, geriatric, and dysphagic patients.

• QbD-Based Suspension Optimization – We utilize particle engineering, viscosity modulation, and polymer-based structuring to stabilize drugs and control release profiles.
• Taste Masking & Palatability – Our ion-exchange resin and microencapsulation techniques improve taste-masking, enhancing acceptability in pediatric and geriatric formulations.
• Improved Stability & Redispersibility – Advanced nano-suspensions and co-processed excipient formulations prevent API precipitation, ensuring dose uniformity.
• Customizable Release Kinetics – We design dual-phase and biphasic release systems to provide immediate and extended-release profiles, optimizing therapeutic efficacy.

Colon Drug Delivery

Targeted colon drug delivery ensures localized treatment of inflammatory bowel diseases (IBD), colorectal cancer, and microbiome-targeted therapies by utilizing pH-sensitive, enzymatic, and time-release mechanisms.

• pH-Dependent Drug Release – We formulate enteric-coated tablets and capsules using Eudragit® polymers to release drugs at specific colonic pH levels.
• Enzymatic Triggering Mechanisms – Our probiotic-based drug delivery utilizes bacterial enzymes to trigger drug release, ensuring precise site-specific absorption.
• Microbiome-Responsive Formulations – We optimize prebiotic-based drug carriers that interact with colonic microbiota, enhancing targeted therapeutic action.
• Time-Controlled Drug Delivery (TCDDS) – We design chronotherapeutic formulations that release drugs after a predetermined lag time, synchronizing therapy with disease progression.

Cutting-Edge Analytical & Bioanalytical Capabilities

Our world-class analytical team ensures product purity, potency, and stability using the most advanced bioanalytical techniques available. From early-stage characterization to regulatory submission, we ensure robust data generation and compliance with ICH, FDA, and EMA guidelines.

• Analytical Method Development & Validation – We offer custom analytical solutions, including high-throughput LC-MS, impurity profiling, and stability testing to ensure drug product quality.
• Biologics Characterization – Our specialized expertise in monoclonal antibodies, peptides, and recombinant proteins allows us to provide detailed structural analysis, aggregation assessments, and potency testing.
• Extractables & Leachables, Nitrosamine Testing – We perform comprehensive extractables and leachables (E&L) studies and nitrosamine risk assessments to ensure packaging and formulation safety.

Regulatory & Commercialization Strategy

We bridge the gap between scientific innovation and regulatory approval, ensuring that your drug product is built for seamless market entry and long-term success. Our expertise in Module 3 CMC documentation, global regulatory strategy, and lifecycle management makes us the ideal partner to accelerate approvals and mitigate compliance risks.

• Regulatory-Ready CMC Documentation – We provide fully compliant, submission-ready Module 3 packages that align with FDA, EMA, and ICH guidelines.
• Technology Transfer & Scale-Up – We streamline the seamless transition from R&D to GMP manufacturing, ensuring scalable production and regulatory continuity.
• Post-Approval CMC Lifecycle Management – We assist with change management, post-approval variations, and global market expansion strategies to help sustain product success.

PHASE ​ APPROPRIATE  ​DEVELOPMENT