Hybridization LC-MS/MS for Sensitive Quantitation of Antisense Oligonucleotides in Plasma and Dried Blood Microsamples
Best Practices for Preclinical Dose Range Finding Studies
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
Inside Preclinical Ocular Research: With Dr. Simone Iwabe, DVM, PhD, DACVO, and Randy Wheeland, BS
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.
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. These barriers pose challenges for effective treatment—challenges that formulation specialists are striving to address with different formulation options.
SYSTEMIC EXPOSURE OF TOPICAL OPHTHALMIC PREPARATIONS
Ophthalmic topical medications are highly concentrated and can be absorbed systemically due to the passage of medication through the nasolacrimal duct into the highly vascular nasal mucosa. Systemic exposure to eye drops occurs when the active ingredients in the drops are absorbed into the bloodstream.
This can happen through the tear duct, the conjunctiva, or the skin around the eyes. Systemic exposure can produce side effects, which formulation scientists work to minimize. Systemic exposure to ophthalmic medications is influenced by several factors, including the high concentration of active ingredients in eye drops, administration techniques that impact absorption, and patient populations, such as infants, pregnant or nursing women, and the elderly are more susceptible to systemic side effects.
HOW CAN ALTASCIENCES HELP
With a deep understanding of regulatory requirements for ophthalmic formulations and cutting-edge manufacturing techniques, Altasciences provides comprehensive services tailored to meet the highest industry standards for your ophthalmic drug development program. We offer customized solutions that align with your specific needs, delivering an optimized suite of services to deliver high-quality ophthalmic drugs for clinical trials or commercial use.
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Altasciences Receives 2025 CDMO Leadership Award in Small Molecule Dosage Form Category
Laval, Québec, March 27, 2025—Altasciences, a nine-time CRO Leadership Award winner, is proud to announce they have been awarded a 2025 CDMO Leadership Award in the Small Molecule Dosage Form–North America category.
Altasciences’ CDMO site supports drug development with formulation, manufacturing, and analytical testing—from discovery to commercialization. Their FDA-inspected facility features Grade C cleanrooms, R&D and analytical labs, ICH stability chambers, and a cGMP warehouse.
"This recognition reflects our CDMO team’s unwavering dedication and expertise, as well as our unrelenting commitment to advancing drug development in collaboration with leading pharmaceutical and biotech innovators,” says Marie-Hélène Raigneau, Co-Chief Operating Officer at Altasciences. “We are grateful for the opportunity to partner with esteemed sponsors from around the globe, providing them with integrated solutions that not only support groundbreaking therapeutic progress but also contribute meaningfully to getting those therapies to those who need them, faster.”
For 14 years, Outsourced Pharma’s CDMO Leadership Awards have recognized the top-performing contract development and manufacturing organizations based on comprehensive industry research, and feedback from sponsors.
“We are thrilled to introduce our 2025 CDMO Leadership Awards winners to the Outsourcing community, and honored to offer such an important tool for drug sponsors in selecting their best-fit partner to help bring life-saving therapies to market,” says Louis Garguilo, Chief Editor at Outsourced Pharma. “The new categories and enhanced scoring methodology that went into this year’s appraisal bring an improved experience for drug sponsors using the resource as well as an ever-so-coveted distinction for the CDMOs.”
Altasciences has formulated, tested, and/or manufactured nearly every available pharmaceutical dosage form on the market, including tablets, liquid- and powder-filled capsules, over-encapsulated capsules, nanomilled suspensions, creams, gels, powders, and terminally sterilized injectables.
Altasciences’ CDMO facility supports all stages of drug development, from early-phase formulation to late-phase scale-up and commercial manufacturing. It ensures batch consistency through in-house analytical testing and environmental monitoring. By providing integrated services and utilizing in-house expertise, Altasciences accelerates the formulation, manufacturing, and analysis processes to expedite the transition from preclinical to clinical phases and facilitate faster delivery of safe and effective therapeutics.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 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, research support, 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. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
jcabana@altasciences.com