The drug development process is an extremely engaging and valuable challenge for improving human health, yet it is also complex, time-consuming, and very expensive. The risk of failure, mainly due to efficacy and safety issues, affects all its phases, with failures causing greater waste in the more advanced phases of the process. This prompts dedicating the utmost care to the preparation of molecules to be studied and undertaking a relentless exploration of new strategies to decrease the so-called 'attrition rate', thereby maximising the probability of success (POS) for the studied molecules: “How can an adverse drug reaction (ADR) be predicted or avoided?”, “How can the selectivity of molecules be determined to effectively prioritise them for subsequent phases of development?”, “How can it be verified that a model organism accurately represents human characteristics?”, “How can a new use be discovered for a molecule that failed in Phase III (Drug rescue) or is nearing patent expiration (Drug repurposing)?”.
To address these and other relevant issues, SPILLOproject, an in silico service provider, has developed an exclusive physics-based technology refined for over 10 years that enables a rapid and efficient analysis of the entire structural proteome of humans, mice, rats, and other organisms, aimed at discovering the target and off-target proteins interacting with any given marketed or developmental molecule. This is crucial for determining or shedding light on its therapeutic effects and ADRs at the biomolecular level.
Importantly, what makes this method unique is that it operates through a flexible and unbiased identification of protein binding sites, which are found even when they are hidden or completely closed. This allows it to succeed in finding even those targets and off-targets that remain elusive to other existing methods. The effectiveness of such an approach is substantiated by numerous experimental validations, many of which have been documented in peer-reviewed scientific journals. Throughout every phase of drug development, SPILLOproject stands out as an ideal innovative partner, dedicated to provide customised services aimed at decreasing the attrition rate and boosting the return on investment (ROI) for biopharmaceutical companies.
To ensure success in the complex journey of drug development, the contribution of another important and reliable partner is also crucial; the lead compound has to be produced firstly on a clinical scale, through a manufacturing process which complies with the requirements of the medicine agencies for its administrations into humans.
A CDMO (Contract Development and Manufacturing Organization) is the outsourcing solution appointed to accomplish this task. While the lead compound will step through all the gates, from Phase 1 till the Phase 3 of the clinical trial to ascertain its therapeutic efficacy and safety, the CDMO undertakes the pivotal task to fulfil the CMC (Chemical Manufacturing Control) needs in the transitionary process that will transform the original lead compound into a drug substance eligible for a New Drug Application. ICROM is a specialised CDMO in the development and Good Manufacturing Practises (GMP) of Active Ingredients; with deep understanding of the Pharmaceutical Industry gained with historical presence on the Marketplace, a diversified Portfolio with global reach and an innovative approach with utmost attention to the Industry needs, ICROM is the partner of choice for pharmaceutical outsourcing able to provide a wide range of tailored services, custom development and custom commercial manufacturing of difficult to make molecules for complex formulations.
The Drug Substance is the key ingredient whose QUALITY attribute will determine its use, in a fitting and approvable Drug Product. The journey will finally lead to a new beginning, with the commercial access of a New Drug on the serviceable markets for benefit of the Patients and human wellness.
ICROM and SPILLOproject with strong commitment and integrity behaviour for such important responsibility, join forces to partner together in this complex journey. Combining expertise and capabilities in a hub of integrated technologies, this new partnership will offer a holistic service to biopharmaceutical companies that need a tailored, outsourced solution to manage their new projects. Professionality, know-how and commitment to excellence!
