The complex and challenging nature of the early phases of drug development can be simplified with an integrated, proactive approach to clinical supply manufacture, where formulation, manufacture and clinical conduct work in tandem with data sharing, program timelines, and critical milestone synchronization. As the program advances to proof of concept, adaptations from earlier steps are accommodated and incorporated without delay. Working with an integrated CRO/CDMO partner can eliminate many logistical challenges, and deliver a more efficient, timely, and cost effective program progression, compressing the time between milestones and decision points.
Starting at API availability, Altasciences works to accelerate the timeline from manufacture to clinical trial administration. By discussing your program objectives at the onset, we can proactively plan for success and manage any complex changes that may arise. With a clear understanding of compounding and dispensing needs, and how your product will be handled at the pharmacy level, we are ready to ensure the availability of supply stays on track throughout your program. Small batch sizes can be tailored from initial formulation requirements, as we adapt based on new information that will be applied to clinical trials.
During early phase human trials, integration of GMP-based, GCP pharmacy-on-demand with accredited GMP CDMO capabilities ensures your timelines are never in jeopardy. Formulation and dosing changes, simple or complex, before or during study conduct and any other needs can be seamlessly managed and synchronized, either at our pharmacy or our CDMO site.
Because our pharmacy processes are based on GMP principles, our experts can handle the majority of study-related changes to formulation or drug product, such as preparation, blinding, and dose changes. When a full GMP intervention or manufacturing change is called for, our GMP-certified CDMO site will perform the necessary changes and rapidly deliver the drug product to the clinic. Methods or customizations developed at each stage are shared, for maximum transparency, knowledge transfer, and the resultant efficiencies.
Having all complementary services on-site is an added level of support. With Altasciences, experts in method development, validation, stability, and QC/QA/QP batch release are always available when needed.
Our CDMO is ready to support beyond early development and carry through the lifecycle for final formulation and commercialization. We provide seamless CMC information to ensure your final product meets regulatory requirements for market authorization. Scalable equipment ensures larger batches are manufactured to specifications, and we provide packaging, labelling, and distribution services for a holistic solution.
This level of real-time integration is reflected in everything we do at Altasciences. We have a unique corporate structure, with two executives sharing responsibility for the range of inter-related operations and services. Constant, clear communication, planning, and program management, are supported by harmonized SOPs and a centralized, cross-functional information sharing platform (Tell Us Once™/Ask Albert) where all your program information is at the fingertips of key personnel. Our 25 years of experience in early phase drug development have proven that the integration and synergy we offer are key to shortening timelines and allowing you to make better decisions, faster.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.