Manufacturing and Analytical Services
ISSUE NO. 40 — Analytical Testing: Accurate and Complete Characterization of Your API to Maximize Bioavailability
In Issue 40 of The Altascientist, different analytical testing techniques to support drug product development specific to bioavailability are explored, including a case study on the manufacturing of a nanosuspension.
During the early stages of drug development, fully characterizing the active pharmaceutical ingredients (APIs) is crucial for optimizing the drug product formulation. Specifically, understanding your API’s particle size, crystalline structure (including different polymorph forms), and dissolution profile to inform downstream formulation dosing decisions for clinical trials.
In this issue of The Altascientist, you will discover:
- methods for identifying and characterizing your API;
- common techniques to determine particle size distribution (PSD);
- formulation approaches to maximize bioavailability; and
- a nanosuspension case study.
Case Study: Innovative Nanosuspension Approach to Maximize API Potency in Preclinical Formulation Development
Each preclinical&nbs
Case Study—Nanosuspension Formulation to Maximize Potency for Preclinical Studies
Top 10 Life Science Resources for Summer 2024
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!
Optimizing for Success: How Sponsors Can Overcome the Challenges in Early-Phase Drug Development
The Challenges With Outsourcing Drug Development
In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in nonclinical and Phase I clinical development.
Five Promising Treatment Areas in Early-Phase Drug Development in 2024
Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings.
Disrupting the CRO Model: Altasciences Participates in Documentary Series for 2024 Global Health Summit
Altasciences is leading the conversation on change in the drug development industry as part of a new documentary series for the 2024 Global Health Summit, hosted alongside the WHO’s 77th World Health Assembly in Geneva in May. The mini documentary explores transformation in the slow-to-change drug development industry.
ISSUE NO. 38 — Achieving Optimal Preclinical Formulation and Drug Product Manufacture
Formulating and manufacturing drugs for preclinical testing is an early—and necessary—step towards pushing your molecule through to human clinical trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating the limits of solubility and maximum volume. To optimize the formulation for preclinical testing, it’s important to consider the following for informed decision-making regarding feasibility, scale-up, and the future success of your program: route of administration, excipients selection, stability testing, scale-up plans and options, and contingency plans.
Issue 38 of The Altascientist explores the key considerations for successful formulation development and manufacture for safety assessment, alongside examining the strategies Altasciences employs to support you in planning your program.
Preclinical manufacturing involves various sub-processes, all of which are critical in overall drug development. And in this issue, you will discover these sub-processes in detail, including:
- formulation development
- manufacturing process development
- scale-up
- process validation
- analytical method development and validation
- quality assurance and control
- stability studies
- regulatory compliance
- risk management
Also included is a case study about how Altasciences helped a client get their new API through the preclinical development phase with a robust formulation at the maximum potency.
The Year in Review 2023
Top 10 Life Science Resources - October 2023
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!