Consulting services
Curiolex has an in-house team of experts and resources to deliver a range of comprehensive drug development services. Coupled with our R&D and manufacturing Platform of trusted partners, Curiolex is able to offer services over various disciplines within the Pharmaceutical and Chemical arenas. Curiolex further offers flexible business models – from sending experts to do development work at our client’s facility, to remote consulting involving conference meetings and secured file sharing – to ensure that projects are completed within budget and time targets.
Curiolex flexible project management models allow for creation, planning and execution of drug development programmes effectively for our global customers, ranging from virtual start-up companies to established pharma companies. Our capabilities and expertise includes CMC, Non-Clinical, Data Management, and FDF development across a wide variety of therapeutic areas. We have extensive experience in discussing these development programs with global regulators and can thus be essential for overseas registrations. With our independent position we can design an optimal program including risk assessment and mitigation, saving time and money whilst achieving project milestone objectives.
AI Systems: The tested multi-platform technologies built by our collaborator BluMaiden Biosciences enable discovery of microbiome-derived small molecule drug candidates. The technologies allow for exploration and collaboration in areas such as clinical data-derived functional gene screening, AI-driven chemical space screening, and in silico ligand and target selection. Additionally, our genome-resolved metagenome analytical workflow services provide high quality microbiome analysis for any type of clinical trials and clinical studies. Among the many potential outputs, microbiome analysis can yield actionable information on patient stratification, effects of microbiome on drug efficacy, and the impact of drug interventions on microbiome. We cater for all types of study designs and sizes and are actively partnering in platform collaborations and/or drug asset discovery projects with Pharma and Biotech.
CMC Services: CMC plays a crucial role in all stages of the product life cycle including early and late phases of development and even after marketing authorization when the product is on the market. To manufacture a pharmaceutical or biological product, a well-defined drug substance and product, manufacturing process and test methods must be developed in order to ensure that the product is safe, effective and batch-to-batch consistent. Our CMC consulting service covers a wide range of activities including product, process and test method development, product stability testing, phase appropriate validation, packaging development, and testing under GMP conditions. Curiolex is an active leader in the CMC activities of our clients.
Class 2 and 505(b)(2): Class 2 filing enables investigators and/or manufacturers to apply for approval in China without having to repeat all the drug development work done for the original, innovator drug. Curiolex team of experts have over 15 years in innovator drug modification (often an improvement) to generate a whole new and differentiated “drug product” – with its own commercial value and exclusivity. We can participate in all stages of development including patent assessment, new dosage form candidate generation, initial testing and evaluation, formal formulation development, clinical assessment participation, and regulatory involvement. Our service can be utilized for a variety of different marketing applications (Branded generics, Drug Efficacy Study Implementation (DESI) Drugs, Drug-device combinations, Prodrugs, and Orphan Drugs) and is particularly well suited for related 505(b)(2) pathway approval under the FDA’s New Drug Application (NDA). The 505(b)(2) is a streamlined process that enables investigators and/or manufacturers to apply for approval in the US without having to repeat all the drug development work done for the original, innovator drug.
API Development: Curiolex provides comprehensive API development service. Our service at least results in reliable product quality and production cost reduction. Full comprehensive Technical Package (TP) is provided for target product and includes all necessary technical support for in-house development by our clients. Curiolex can work remotely or send experts to demonstrate procedures and oversee the complete development, from R&D to scale-up manufacturing, exhibit batches and DMF preparation and filing. Additionally, we provide programs to assess and improve our client’s existing manufacturing procedures (both on R&D and production scale). For instance, by replacement outdated technology with modern API manufacturing practices resulting in improved cost and EHS index.
Finished Dosage Development (FDF): Curiolex will design and implement a FDF grogram by clearly defining a “Product Development Strategy Note (PDSN)” based on targeted geography, the facilities of our client, and regulatory and IP situation. The CQAs of RLD/RS are defined so that the PDSN for implementation maximizes the success of development. Development and Implementation of Pre-formulation protocols for oral solids and injectables such as API characterization, API-Excipient compatibility studies, Stress studies on Preformulated/Proto-type composition to understand the parameters, and improve the stability and packaging of the final product. Some focus areas include:
(i) Development and Implementation of formulation development program through Quality of Design (QbD) and Design of Experiments (DoE) frame-work to achieve early proto-type with quality parameters similar to RLD/RS. This also involves development of “discriminatory/bio-relevant” dissolution test based on Biopharmaceutic Classification (BCS) system and nature of drug dissolution from RLD
(ii) Where client has failed pre-biostudy or pivotal-biostudy, Curiolex will review the formulation research data, undertake a comprehensive review of the formulation development and pilot-bioequivalence data provided by client, and prepare an executive summary report (ESR) identifying the possible root-cause for lower bio-availability and provide possible improvements need to be made for further development. Complete design of appropriate experimental trials to improve the formulation to maximize successful bio-equivalence in next attempt. Appropriate testing methods (specifically, dissolution) to identify most suitable in-vitro conditions to guide the formulation development (i.e., clinically relevant dissolution condition) are provided.
(iii) Reverse Engineering or Deformulation data for RLDs/RS for Generic Product Development. Through our state-of-the art formulation labs and CRO/CDMO partners Curiolex will generate all Critical Quality Attributes (CQAs) of RLDs/RS such as Dissolution Profiles, PSD and Polymorphic form of API, Impurity Profile, and other parameters that are critical to achieve bio-equivalence and stability. This data will be part of CMC section of CTD and will be “handy” information for clients to begin formulation development work.
(iv) Development and Supply of Preliminary Analytical Methods for RLDs/RS. We provide preliminary analytical methods for RLDs/RS such as Dissolution Profiles, Assay, Related Substances, PSD and Polymorphic form of API services, and other parameters that are critical to achieve bio-equivalence and stability. These methods could be readily applied for development of Test formulation. In addition, Curiolex will also offer Method Validation and Transfer services as per CFDA/ICH guidance requirements based on client needs.