Explore the key considerations for successful formulation development and manufacture for safety assessment, and learn about the strategies Altasciences employs to support sponsors.

- 0:35 — Introduction
- 3:34 — Considerations for Preclinical Drug Formulation
- 7:36 — Preclinical Drug Product Manufacturing 
- 9:46 — Steps in Preclinical Drug Product Manufacturing
- 13:49 — Quality Assurance and Control 
- 14:33 — Regulatory Aspects
- 15:42 — Risk Management 
- 17:17 — Case Study 
- 21:27 — Conclusion 

Formulating and manufacturing drugs for preclinical testing is an early, crucial step toward human trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating to the limits of solubility and maximum volumes. To optimize the formulation for preclinical testing, one must consider the route of administration, selection of excipients, stability testing, plans and options for scale-up, and contingency plans.

Issue 38 — Optimal Preclinical Formulation and Drug Product Manufacture

According to the World Health Organization, at least a billion people are currently living with vision impairment from a preventable or treatable source. The main conditions causing their distance vision impairment or blindness are cataracts, refractive error, age-related macular degeneration, glaucoma, diabetic retinopathy, and presbyopia. 

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 this issue of The Altascientist, we explore how to meet the challenges of formulation development for ocular therapies. 


Issue 43 — Advancing Vision Care With Formulation and Manufacture of Ocular Therapeutics

As an end-to-end CRO/CDMO, we have expert knowledge in all early stages of drug development, and we’re sharing that knowledge with you in The Altascientist: The Audiobook. 

Each issue is a deep dive into a specific area of early-phase drug development, providing insider tips, considerations, and case studies. 


Altasciences is a 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.

Issue 38 — Optimal Preclinical Formulation and Drug Product Manufacture

The Altascientist

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