Pharmaceutical Formulation Development
TAILORED FORMULATION DEVELOPMENT AND MANUFACTURING SOLUTIONS
Proper formulation of active pharmaceutical ingredients (APIs) is essential for achieving therapeutic efficacy, ensuring patient safety, maintaining product stability, optimizing pharmacokinetics, meeting regulatory requirements, and enhancing cost-effectiveness in pharmaceutical development.
Our scientists design and optimize drug formulations to maximize therapeutic benefits and minimize risks for clinical trial participants. They ensure the reliability, safety, and efficacy of the drug product being evaluated, ultimately supporting clinical development and regulatory submission.
Connect with our seasoned experts for all your formulation development needs.
SHAPING THE FUTURE OF MEDICINE: COMPREHENSIVE PHARMACEUTICAL FORMULATION DEVELOPMENT
Altasciences’ 64,000 square-foot GMP manufacturing facility is set up with cutting-edge equipment, processes, and technologies that allow our scientists to successfully pre-formulate and formulate even the most complex and poorly soluble APIs. We provide:
- optimal drug solubility and bioavailability
- dose accuracy and uniformity
- data on stability and shelf life
- optimal dosage form and route of administration
- adherence to regulatory standards
- predictive value for clinical trials
We have decades of experience developing, testing, and manufacturing a wide range of dosage forms and can also handle DEA-controlled substances (drug Schedules I to V) and highly potent compounds (HPAPIs).
With on-site laboratories providing analytical testing services, our scientists optimize your drug formulation to ensure the efficacy and safety of the drug substance being evaluated in preclinical studies to maximize the outcome of your clinical trials.
ASK AN ALTASCIENTIST ―Senior Formulation Scientist, Andrew Buis, explains how the process of nanomilling can help formulate poorly soluble APIs.
EXPERT FORMULATION DEVELOPMENT FOR PRECLINICAL SAFETY TESTING
Pharmaceutical formulation development is integral to the success of preclinical safety testing. It ensures accurate dosing, stability, and safety of drug products, providing essential data for regulatory submissions and guiding the progression of a drug through the various stages of development. A carefully crafted formulation facilitates preclinical studies and contributes to the translational success of drug candidates from preclinical to clinical phases as it can help predict the drug's behavior in humans.
Formulation development for preclinical studies involves several key considerations to ensure the reliability and applicability of findings, including:
- chemical characterization of the API;
- safety assessment of the drug substance, including its toxicity profile;
- dose selection based on PK and PD;
- the solubility, stability, and bioavailability of the API;
- the appropriate route of administration based on drug absorption, distribution, metabolism, and excretion (ADME);
- compliance with regulatory requirements and guidelines (e.g., GLP and ICH);
- validation studies to ensure the suitability of the chosen animal model; and
- formulation refinements based on initial preclinical findings to optimize clinical trial outcomes.
Having our own preclinical research team that works hand-in-hand with our formulation scientists offers numerous advantages, including streamlined development, optimized formulation, early risk identification, enhanced product quality, and cost efficiency. Our experts across phases and sites move in unison to accelerate your drug development timeline, minimize risks, and ensure the manufacture of high-quality pharmaceutical products for patients worldwide.
PODCAST ―Watch Altasciences’ experts share tips on facilitating your IND-application by ensuring the successful formulation of your API for preclinical testing.
PAVING THE WAY FOR OPTIMAL CLINICAL DEVELOPMENT
At Altasciences, we use a multidisciplinary approach and follow best practices in pharmaceutical formulation development to help reduce production costs, minimize batch-to-batch variability, enhance manufacturing efficiency, and advance your most promising drug candidates through the preclinical phase―clearing the path for effective clinical research and regulatory approval.
OUR FULL SPECTRUM OF DRUG PRODUCT MANUFACTURING SERVICES
Dive deeper into Altasciences' extensive range of pharmaceutical development and manufacturing services. From discovery to commercialization, our comprehensive offering ensures a seamless transition through each stage of drug development.