Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes
Up Close and Personal with Dr. Simone Iwabe, DVM, PhD, DACVO
Meet Dr. Simone Iwabe, DVM, PhD, DACVO
Senior Veterinary Ophthalmologist
Three Key Advantages of Conducting Early-Phase Clinical Trials in North America: An Overview of the Webinar “A Hop Across the Pond”
Regulatory processes can be challenging, and potential solutions can be found in broadening your focus to include clinical sites in the U.S. and Canada for your drug development strategy. With an understanding of how regulatory agencies and market environments may differ, you will be in a better position to optimize your program. In Altasciences’ on-demand webinar, A Hop Across the Pond, Ingrid Holmes, Vice President of Global Clinical Operations, and Dr.
Test Your Preclinical Toxicology Knowledge
In drug development, toxicology evaluates and examines adverse effects of an investigational product on a living organism to determine its initial safety and dose-specific effects. But did you know that toxicology is not limited to drug development? Toxicology is a branch of science that deals with toxins and poisons, and their effects and treatment; other types of toxicology include forensic toxicology, environmental toxicology, food toxicology, and veterinary toxicology.
Take this quiz to discover how much you know (or don’t know) about toxicology.
Current Trends in Drug Development
The drug development landscape has been evolving over the years, from an earlier emphasis on blockbuster drugs developed in-house by large pharmaceutical companies, t
ISSUE NO. 22 — Nanomilling for Better Solubility and Improved Bioavailability
A crucial feature of drug development is bioavailability, defined as “the ability of a drug to be absorbed and used by the body.” For a drug to be bioavailable, it must first be soluble, meaning able to be dissolved, especially in water. Many drugs on the market today are poorly water soluble, and patent extensions or 505(b)(2) new patents become possible for formulation improvements delivered via nanomilling.
In Issue 22 of The Altascientist, we review:
- solubility classifications
- overcoming solubility challenges
- the benefits of nanomilling
- how nanomilling works
- maximizing formulation
Case study included!
Overcoming Solubility Challenges With Nanomilling
Promising therapeutic molecules, even if classified as poorly soluble, can be developed successfully. There are multiple technologies available to increase the solubility and oral bioavailability of poorly soluble molecules being developed as active pharmaceutical ingredients (APIs) by reducing their particle size.
Nanomilling is a universal technique that can be applied to almost any API with water solubility below 200 μg/mL. It is a very adaptable drug delivery platform suitable for oral, injectable, inhalable, and buccal applications, for which fine drug particulates are especially desired in formulations.
Nanomilling is a unit operation where mechanical energy is applied to physically break down coarse particles to finer ones. It has wide commercial and industrial applications, as every drug can be ground to finer particles, whether aqueous or non-aqueous soluble. Decreasing the size of the API molecule increases the size of the specific surface area; the larger surface area allows for greater contact with water, increasing the API’s dissolution rate and bioavailability.
The Benefits of Nanomilling
Benefits of particle size reduction for the parenteral route include small dose volumes (resulting from high drug loading) and avoidance of harsh solvents and/or extreme pH conditions. Advantages for the pulmonary route include the ability to use inhalers intended for solutions, as well as the ability to produce spray-dried powders whose particle sizes are optimized for deep lung delivery.
Other advantages include reduced fed/fasted variability in both liquid and solid dosage forms, faster onset of therapeutic action, low excipient side effects, and the ability to run continuously.
How Altasciences Can Help Improve Your Drug’s Bioavailability With Nanomilling
Nanomilling is a highly complex process requiring a unique level of CDMO expertise that can only be gained through extensive experience with developing a broad range of APIs.
At Altasciences, we can take your API from formulation to commercialization. We have the necessary procedures, equipment, and experience to work with any formulation. Our highly skilled teams work with the latest equipment, including the NETZSCH DeltaVita® 15-300 mill, that with our wet milling options can reduce particles to nanometer size, fill vials in a range of sizes (from 0.3 ml to 500 ml), and package them.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
Download publicationThe Canadian Business Quarterly: Altasciences — Fully Integrated Problem-Solving Solutions
Contract Pharma: Altasciences Names Wendell Davis VP, Pathology
Dr. Wendell P. Davis Joins Altasciences as Vice President, Pathology
Laval, Quebec, February 7, 2022 – Altasciences announced today the appointment of Dr. Wendell P. Davis, D.V.M., Dipl. ACVP, as Vice President, Pathology, effective February 7, 2022.
Dr. Davis is a nonclinical development professional with extensive experience in toxicologic pathology and a proven track record of building and leading high functioning pathology groups in both the biotechnology and CRO sectors. He is a proven leader with a passion for building pathology capabilities and mentoring pathologists, research, and laboratory scientists.
As a study pathologist and peer reviewer, he has experience evaluating small molecules, biologics, oligonucleotide, and an array of RNA therapeutics modalities across a range of preclinical species and routes of administration, in support of both early candidate selection and regulatory filings.
Dr. Davis has also maintained an active role in the industry as a member of the Society of Toxicologic Pathology and as a diplomat member of the American College of Veterinary Pathologists.
“Wendell’s track record and leadership experience in the fields of anatomical pathology, discovery toxicology, and toxicologic pathology, as well as his ability to mitigate challenging toxicologic pathology issues will make him a great addition to our team, and deliver expert guidance for our clients,” said Mike Broadhurst, General Manager, Preclinical Services, at Altasciences.
Altasciences has strategically located preclinical research facilities in Seattle, Scranton, and Columbia, U.S.A. With over 25 years of experience conducting safety assessment, Altasciences offers a full range of in vivo GLP and non-GLP preclinical studies in multiple species to thoroughly assess the safety profile of molecules.
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 25 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, 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.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com