In recent years, advancements in oncological research have fueled a surge in demand for highly potent active pharmaceutical ingredients (HPAPIs). So much so that the HPAPI market is estimated to reach USD 31.5 billion by 2029.

Thousands of HPAPIs are currently in development that promise lower dose requirements, enhanced efficacy, improved patient compliance, and fewer side effects. 

Manufacturing these drug products involves expert specialization and careful consideration to ensure that GMP regulations for drug submissions are met, the risk of exposure for CDMO-related personnel is reduced, and every effort is made to prevent cross-contamination.

In Issue 35 of The Altascientist, we explore the intricacies and critical considerations for the safe and compliant manufacture of highly potent drugs, in particular HPAPIs, which include:

• categorization of HPAPI potency;
• classification of exposure potential;
• appropriate containment strategies;
• engineering controls and waste management practices; and
• global regulatory requirements.

In Issue 33 of The Altascientist, we explore how a comprehensive, end-to-end integrated approach to drug development for central nervous system (CNS) therapeutics can take you seamlessly from lead candidate selection to market. 

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.

With detailed case studies, study considerations, and more, this Issue covers:

• preclinical safety and toxicity testing,
• formulation and manufacturing,
• early-phase clinical trials, and
• bioanalysis.

Liquid-filled hard-shell capsules (LFHCs) are a popular formulation for oral solid delivery of chemical drugs and nutraceuticals. Often selected for drugs with poor solubility/bioavailability, LFHCs also have applications in a number of other situations, including specific benefits during early-phase clinical development.

In Issue 28 of The Altascientist, you will find: 

• Applications of LFHCs
• The production process
• The role of excipients
• Other advantages of LFHCs A case study
• How Altasciences can help

Ophthalmic medications have a particular set of challenges that can impact their speedy and successful path to market. From prototype formulation through preclinical testing, early-phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities. It is best to entrust drug development to a partner with regulatory knowledge, technical expertise, and a thorough understanding of the market in this growing therapeutic area. From current reality to future trends, being at the forefront of ophthalmic drug development delivers tangible benefits to sponsors.

In Issue 27 of The Altascientist, we dive into all areas of ophthalmic drug development, including: 

• Prototype development, formulation, and manufacturing
• Preparing for first-in-human studies
• Species and strain selection parameters
• Routes of administration
• Specialized ocular assessments and equipment
• bioanalysis
• Phase I clinical research
• Phase II to commercialization

Three case studies are also included!