Manufacturing and Analytical Services
Altasciences' Facilities: Moving in Unison
Embarking on a Career in Drug Development
Getting to the Heart of Science with Amber malloy
ISSUE NO. 35 — Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs
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.
Top 5 Ways Integrated Drug Development Solutions Save You Time and Money
Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion, without, for the most part, shorter development time
ISSUE NO. 33 — End-to-End CNS Drug Development Solutions
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.
Case Study―Evaluating Milling Conditions for Scaling Up a Nanosuspension Drug Product
Ophthalmic End-to-End Drug Development Solutions
Six Reasons to Choose Altasciences as Your CDMO Partner
Whether you are embarking on Preclinical safety testing, Phase I clinical trials, or need manufacturing services f
ISSUE NO. 28 — Applications of Liquid-Filled Hard-Shell Capsules in Drug Development
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
Case Study―Product Manufacturing and Analytical Testing for an Ocular Client