Altasciences Receives Accreditation From College of American Pathologists
Laval, Québec, October 31, 2022 – The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Altasciences’ clinical site in Los Angeles, California, based on results of a recent on-site inspection.
Altasciences was advised of this national recognition and congratulated for the excellence of the services being provided. Altasciences’ Los Angeles site is one of more than 8,000 CAP-accredited facilities worldwide.
“This prestigious accreditation is a testament to the high-quality work and oversight by Altasciences’ dedicated and passionate team in Los Angeles. We are pleased to give our clients the peace of mind that comes with working with a CAP-accredited biorepository, and are proud to have a seal of approval that reflects the quality of our work,” stated Dr. David Nguyen, General Manager and Medical Director at Altasciences’ Los Angeles site.
The CAP, first in the industry to offer an accreditation program for biorepositories, based the Biorepository Accreditation Program on the principles of its Laboratory Accreditation Program. The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal to, or more stringent than, the government’s own inspection program. Currently, there is no federal mandate for biorepository accreditation.
The CAP Biorepository Accreditation Program, a three-year accreditation cycle, includes on-site inspection, desk review, and optional education modules and gap assessment. As part of the on-site inspection, the CAP uses accreditation checklists to provide a comprehensive, up-to-date blueprint of quality practices to assist biorepositories in improving their operations and ensure quality. Further, a desk review offers a remote review of a biorepository’s quality management plan, certain procedures, and select quality and process statistics. The program is designed to ensure the highest standard of patient care.
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.
About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing program, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP ANNUAL REPORT at cap.org.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Selecting the Right Bioanalytical Platform for Your Molecule
Test Your Knowledge of PCR Applications
PCR testing continues to be in the spotlight as a reliable way of screening for COVID-19 and other viruses in patients. Its amplification process enables it to detect small portions of genetic material in these viruses. But PCR can be also used for a broad range of additional applications.
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
Altasciences Expands Laboratory Capabilities in Columbia
Laval, Québec, October 19, 2022 – Altasciences’ laboratory facilities in Columbia, MO, are undergoing a significant expansion, with completion expected in 2023. The new 8,000-square-foot space will mirror Altasciences’ current bioanalytical laboratory in Laval, Québec, with state-of-the-art equipment and bioanalytical capabilities. This will supplement the service offering already available at Altasciences’ site in Seattle, WA, to support preclinical and clinical studies conducted in the U.S.
The laboratory’s strategic location, in close proximity to both preclinical and clinical facilities, reflects Altasciences’ focus on ensuring a seamless collaboration between teams, sites, and phases of development.
“We are very excited about the laboratory expansion at our Columbia site. With this additional full-service, state-of-the-art bioanalytical and flow cytometry laboratory, we look forward to continuing to provide our usual high-quality, timely analyses of study samples for our clients,” said Lynne Le Sauteur, Vice President, Laboratory Sciences, at Altasciences.
Conveniently located in the Midwest, the Columbia site is near a fast-growing university town that is easily accessible from across the country. The bioanalytical laboratory will contain 48 workbenches in an open space, with services that include mass spectrometry and ligand binding assays, flow cytometry, biomarkers, as well as cell culture.
“At Altasciences, we continue to increase capacity in support of our strategic growth plan, and look forward to the completion of this new laboratory to supplement our existing North American service offering,” stated Andy Brown, Columbia Site Director, at Altasciences.
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.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Altasciences Expands Strategic Support for Early Drug Development in Europe and Adds Key Employees to Its Preclinical Team in North America
Laval, Québec, October 14, 2022 – Altasciences hired two expert advisors to support its strategic growth in Europe, while its preclinical team continues to expand with the addition of two key employees.
Providing strategic input into steering Altasciences’ drug development solutions direction in Europe, Peter Varney joins the company as Pharma Development and Strategy Advisor. Peter brings 40 years of experience in commercial development, strategic alliances, and relationship management at Covance/Labcorp to his new position. Hazel Clay, with over 30 years of experience in supporting the development of innovator pharmaceutical assets at Covance/Labcorp, plays a key role as Drug Development Advisor in Altasciences’ European expansion. Both Peter and Hazel are based out of Altasciences’ offices in Harrogate, UK.
"With their extensive experience and keen strategic vision, Peter and Hazel are important assets to Altasciences’ expansion into the European market. We wanted to provide our European clients access to in-depth knowledge on early phase drug development to help them get better drugs to market faster," stated Chris Perkin, Altasciences’ Chief Executive Officer.
In addition, Dr. Lisa Biegel joins Altasciences as Senior Scientific Director, Preclinical Services, and will be based at the Columbia, MO, facility. With over 30 years of industry experience in regulatory toxicology at Covance/Labcorp, Lisa will provide leadership and oversight, as well as strategic scientific input, to the study direction and reporting teams.
Furthermore, Annette Kenser joins Altasciences as Senior Director of Quality Assurance, Preclinical Research. Annette has extensive experience as a scientific quality assurance auditor, and will focus on identifying areas of improvement while aligning quality assurance activities throughout the organization.
"We are pleased to welcome Lisa and Annette to Altasciences, and look forward to benefitting from their talents and contributions in the preclinical space," said Andy Brown, Site Director at Altasciences’ Columbia preclinical facility.
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.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Immunogenicity Target Interference: A Novel Blocking Approach
A Snapshot of the Webinar “Development of a Cell-Based Assay”
Cell-based assays are usually used to represent the mechanism of action (MoA) of the administered drug. Throughout various stages of drug development, they may be used for different purposes. These include detecting the presence of neutralizing antibodies (NAbs) and evaluating a drug’s potency. In Altasciences’ webinar, “Development of a Cell-Based Assay,” Dr.
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
Applications for Liquid-Filled Hard-Shell Capsules in Your Drug Development Program
The use of modern drug discovery approaches, such as combinatorial chemistry and high-throughput screening, as well as structural understanding of drug-target binding by X-ray diffraction and molecular modelling, has resulted in an increasing percentage of highly potent lead compounds.
The majority of these compounds have high-melting points and poor aqueous solubility, which directly impact their dissolution and bioavailability. In an LFHC, readily metabolized lipid-based solutions are used as liquid carriers, providing for optimized absorption of the active pharmaceutical ingredient (API).
LFHCs offer several advantages for handling these challenging APIs, including:
• improved safety in processing and administration of potent drugs
• ease of administration
• flexible application
• abuse-resistant formulations
How Altasciences Can Help With Your Liquid-Filled Hard-Shell Capsule Formulations and Manufacturing
Altasciences has a proven track record and thorough expertise with LFHCs, having completed numerous projects over the years, for a wide range of clients. Our highly knowledgeable experts will assist you in determining the most appropriate and efficient program parameters, from batch size to excipient selection and capsule composition, color, and banding options. Our skilled operators use state-of-the-art machinery for every step of the process. We perform comprehensive process validation prior to manufacture, identifying and correcting any potential issue before it becomes a problem. We provide 100% manual inspection of the finished capsules and take pride in doing the job right the first time, every time.
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.
Development of a Surrogate Cerebrospinal Fluid Matrix for Quantitative Analysis of Antisense Oligonucleotides by Hybridization LC-MS/MS