The precise medicinal chemistry methodology can be a key differentiator to fast, efficient drug discovery. Expert, experienced drug hunters agree that med-chem can reduce your time to decision point.
Cellix Bio Pharma focuses to combine the AI computational power to the chemical and biological space in order to streamline drug discovery, design, development, and optimization that can expedite and enable hit identification, hit-to-lead, and optimize ADME and toxicology profiles as well as anticipate any safety issues.
Virtual Screening, High-throughput Screening on proprietary library database and Knowledge-based design.
Identification of potent and selective compounds with desirable PK and Pharmaceutics.
Optimization of Potency, PK, efficacy and safety profiling to deliver an optimized candidate.
Pre-Formulation Development Services
Cellix Bio Pharma focus is on the unique challenges of formulation development for compounds that are highly insoluble, highly unstable, and/or have poor bioavailability. This emphasis has made Cellix Bio Pharma an expert with the capability and track record to tackle the harshest formulation challenges for problematic drug candidates.
We focus on ensuring every stage of product development is successful. Our expertise is to focus on overcoming the challenges faced during studies of flowability, solubility, selection of drug-excipient combination, dissolution profiling, impurity profiling, bioavailability and bioequivalence.
Pharmaceutical Formulation Development Contract Services
Cellix Bio Pharma offers a range of Formulations & Analytical Services that include formulation product development, analytical R&D, reformulation and stability studies. We also offer standalone Analytical services for third party formulation products.
Our drug product formulation development teams offer design and optimisation of formulations for powders, capsules, liquids, ophthalmic and solids, semi-solids, inhaled, nasal, nebulised, pressurised and topical drug formulations. We provide focused understanding from an early stage of development tailored to your new chemical entities (NCE) and NMEs, from feasibility through to development support, Phase I and Phase II clinical trials, scale-up and transfer to commercial manufacturing.
- Drug selection
- Solubility studies/particle properties
- Compatibility with standard and proprietary formulations
- Generation of preferred products properties
- Selection of vehicle type
Formulation development - composition
- Formulation compounding
- Selection of formulation/formulation candidates
- Stability studies (screening and accelerated studies)
- In vitro release and penetration studies
- Selection of lead candidate(s)
- Tech transfer of manufacture to CMO
Formulation development - manufacturing
- Manufacturing process/method
- Upscaling to Kilos scale
- Generation of data for regulatory evaluation
- Generation of documentation to the CMC part of the registration file
Intellectual property (IP)
- Development of patentable compositions/products
- Generation of patent applications
- Investigation on patentability/potential infringement
Our expertise helps accelerate project timelines and includes pre-formulation, excipient-API compatibility assessment and optimisation, physicochemical testing, formulation screening, lab-scale formulation and accelerated stability studies to achieve the desired product characteristics.
Cellix Bio Pharma has the right equipment, facilities and highly dedicated formulation development specialists to help you arrive at the optimal dosage form for your API and application. We use our formulation development methodology based on comprehensive analysis of patents, scientific literature, compendia information, critical quality attributes (CQA) and quality target product profiles (QTPP) of the respective drug delivery system and nature of the molecule.
With a holistic approach to service provision including raw material quality control, scale-up, pilot scale batch manufacturing and testing, GMP clinical batch manufacturing, stability storage, impurities testing, as well as release testing with QP release, we offer a one-source solution for materials supplies for use in Phase I and II clinical trials.
We develop optimized processes that ensure smooth commercial manufacturing. We are sensitive in utilising the client investments/budgets to deliver a cost-effective solution for their formulation development needs. We help pharmaceutical companies to successfully resolve their challenging pharmaceutical compounds both in early-phase formulation development and as well as full generic development.
With dedicated teams of highly experienced analysts and specialist formulation and process development scientists, we offer a truly flexible service which will help you develop the optimal formulation and manufacturing processes for your drug product. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.