Clinical Trials
Responsible AI frees scientists to focus on science, by Nicole Maciolek, Executive Vice President, CRO Services
CLINDMO: Where Clinical Innovation Meets Manufacturing Excellence
ISSUE NO. 46 – Spray-Dried Dispersions
Spray-dried dispersions (SDDs) are an effective method to improve solubility and bioavailability of your active pharmaceutical ingredient (API) in early-phase drug development. The spray drying process involves converting a liquid into a dry powder, with the resulting SDDs benefiting from improved characteristics for further developments. Spray drying can also be combined with nanomilling to further improve the bioavailability, and for flexible downstream processing.
In Issue 46 of The Altascientist, explore:
- how SDDs improve efficiency of early-phase drug development
- applications and benefits of spray drying in early-phase drug manufacturing
- advances in spray drying technology for pharmaceutical development
- the use of spray dry technology in early-phase development of proteins and peptides
- key considerations for the development of spray-dried pharmaceuticals
Clinical Trials Without Boundaries: Multi-Site Solutions at Altasciences
ISSUE NO. 43 — Advancing Vision Care With Formulation and Manufacture of Ocular Therapeutics
According to the WHO, at least a billion people are currently living with vision impairment from a preventable or treatable source. Precedence Research reports that the global ophthalmic drug market size is estimated to double in 10 years, from $34.6 billion in 2021 to an estimated $68.93 billion by 2030.
The development of pharmacological interventions for many of these conditions has been accelerating, supported by new delivery methods and formulation approaches. For conditions that require surgery or corrective devices, eye drops are an important part of diagnosis, and pre- and post-surgery treatment plans.
In Issue 43 of The Altascientist, we explore key considerations for ophthalmic product manufacturing, including formulation, scalability, regulatory compliance, and quality control:
- Recent developments in ophthalmic medications
- Unique barriers for drug delivery to the eye
- Common types of ocular formulations
- Formulation for effective ocular drug delivery
- Systemic exposure of topical ophthalmic preparations
- Ocular gene therapy
- Manufacturing ocular drugs for clinical trials and commercialization
- A case study
THE CHALLENGES OF OCULAR DRUG DELIVERY
The eye has natural anatomical barriers that restrict the amount of medication reaching its intended target. These include the cornea’s outer layer, the conjunctiva, and the blood-aqueous and blood-retinal barriers. These structures resist water-based drugs, limit absorption, and tightly regulate what enters the inner eye. Additionally, the eye's rapid tear film turnover continuously flushes out medication.
Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me
By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services .
Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD
Many of my colleagues and I are members of the Cross-Company Abuse Liability Council (CCALC), where I have been a co-chair for the past seven years, and a member for 15.
The Year in Review 2024
Case Study: How Altasciences Launched a Phase I Study 70% Faster Than the Industry Standard
Clinical trial start-up is a critical phase that carries many risks of delay, that can adversely impact the study timelines and budget. Altasciences was able to achieve an expedited project launch from the typical 12-week start-up process to just 3.5 weeks for a client by aligning our internal team on all objectives, engaging in open dialogue with the sponsor, and optimizing project management by assigning two project leads in two different time zones.