Background Data in the Sinclair Nanopig™

Pushing the Envelope: Detection of Generic Human IgG in Cynomolgus Monkey Serum via Quantitative ELISA

Hybridization LC-MS/MS for Sensitive Quantitation of Antisense Oligonucleotides in Plasma and Dried Blood Microsamples

Dose range finding (DRF) studies are the foundation of preclinical drug development, providing crucial information on safety data to assist in the dose level selection before advancing into to

Dr. Simone Iwabe, DVM, PhD, DACVO, and Randy Wheeland, PhD

Altasciences has been at the forefront of ophthalmic drug development for over 30 years, having completed more than 100 ocular studies to assess the safety of new drug products intended for human use.

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.

By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services .

Insights Care: Altasciences Revolutionizing Early-Phase Drug Development

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