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.

Medical Writing Expertise Is at the Heart of Your Submission

Collaboration and communication means quality documentation for your drug development program. Our Medical Writing teams collaborate constantly with our experts and yours, ensuring that very scientific document required for your study is accurate, complete, and-compliant with regulatory guidance. From initial protocol to the final clinical study report, we deliver rapidly, without compromise.

As a stand-alone solution, or part of an Altasciences study program, our Medical Writing team is ready to support you. You can work in unison with us on a Full-time equivalent (FTE)basis, or project by project, the choice is yours.

Medical Writing

Development of a Surrogate Cerebrospinal Fluid Matrix for Quantitative Analysis of Antisense Oligonucleotides by Hybridization LC-MS/MS

A Novel Method for Performing Linearity Assessments in Whole Blood Prepared Using a Lyse/No Wash Procedure

September 2022

Our Altascientists are hard at work, whether it’s on your drug development projects or producing insightful scientific resources to share their knowledge with you. Catch up on what you may have missed, or revisit some highlights from the last three months.

The Drug Development Journey

A Message from Our CEO to You
Each quarter, Chris Perkin reflects on the past, present, and future of Altasciences.

News: Hoth Therapeutics Chooses Altasciences to Manufacture HT-TBI
Hoth Therapeutics, Inc., a patient-focused biopharmaceutical company, has signed an agreement with Altasciences to manufacture HT-TBI, a novel point-of-care therapy for the treatment and/or prevention of secondary brain injury resulting from ischemic stroke and traumatic brain injury.

Award Announcement: Altasciences named finalist for Scrip Awards 2022
Altasciences was placed on the Scrip Awards 2022 shortlist for “Best Contract Research Organization — Full-Service Providers.” The Scrip Awards recognize the best innovations and achievements in global biopharma among 400 industry leaders.

Audiobook Series: Listen to all issues of your favorite scientific journal, The Altascientist
Our full library of The Altascientist is now available as audiobooks. Whether you want to listen in the car, on the trails, or in the comfort of your own home or office, catching up on the latest explorations in early phase drug development has never been easier.

Scientific Journal: Issue 27—Complexities of Early Phase Ophthalmic Drug Development
Drug development in the ocular space has specific challenges. The eye is a multi-faceted organism, and has many barriers to drug delivery. Read or listen to Issue 27 of The Altascientist.

News: A Conversation with Chris Perkin, a Forward Thinker in the Research Space!
Insights Care interviewed CEO Chris to learn about his journey through nearly 50 years in the CRO industry, as well as Altasciences’ flexible, proactive solution.

Preclinical Services

On-Demand Webinar: Animal Disease Models and Overcoming Technical Challenges—Experimentally Induced Hemophilia Type A
Dr. Norbert Makori, Vice President, Toxicology, discusses disease models and how to overcome the technical challenges in developing an animal model for hemophilia type A.

Audiobook: Altasciences’ Nonclinical Safety Testing Guide
Advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials. This audiobook provides a high-level overview for the preclinical component of your drug development program.

Clinical Services

Blog: Five Reasons to Place Early Phase Clinical Research in Canada
Conducting your early phase clinical research in Canada can result in significant time and cost savings, in addition to other advantages.

Quick Chat: The Makings of a CNS Center of Excellence (with Dr. Milovan)
In this 5-minute interview, Dr. Denise Milovan, Senior Neuroscientist and Neuropsychologist, shares her work experience and insight on what makes Altasciences a CNS Center of Excellence.

Scientific Journal: Issue 25—Flexibility in Phase I Study Timing
A Phase I and II combined protocol can give you an earlier, more complete understanding of your drug. Read or listen to Issue 25 of The Altascientist for a deeper look at the possibilities (includes two case scenarios).​​​​​

Manufacturing and Analutical Services

Quick Chat: Complex and Customized Formulation Development (with Andrew Buis)
Not every CDMO is able or equipped to formulate, manufacture, analyze, and handle your highly potent APIs and controlled substances. Andrew Buis, Senior Formulation Scientist, describes how the experience and training of Altasciences' experts offers unique advantages to partners.

News: Altasciences Continues Manufacturing Expansion in Philadelphia with a Client-Dedicated Building Project
Alongside long-standing partner Alladapt Immunotherapeutics, Inc., we celebrated the groundbreaking of our latest CDMO expansion: a client-dedicated, 53,000-square-foot, state-of-the-art building to meet Alladapt’s Phase III and commercial requirements.

On-Demand Webinar: Advantages of Terminal Sterilization Over Aseptic Manufacturing
It is a regulatory requirement that drug products be terminally sterilized as long as they are able to withstand it. Derek Prince, President at Prince Sterilization Services, and our own Andrew Buis discuss how this process is less complex, less time-consuming, and less costly, and more easily reproducible than aseptic manufacturing.

Bioanalytical Services

Podcast: Microsampling—When Small Steps Lead to Big Outcomes
Dr. Donald Chace, Senior Application and Product Specialist at Capitainer, and Jeff Plomley, Scientific Director at Altasciences, discuss device technology, the importance of acquiring precise and accurate data, and much more.

Blog: Five Lesser-Known Uses for PCR
PCR testing has been in the spotlight as the most reliable way of screening for COVID-19 in patients since the beginning of the pandemic. But what is PCR? And what are its other uses?

Research Support Services

Scientific Journal: Issue 26—CDISC Data Standards
CDISC and SEND standards simplify and speed up analysis of your drug development program’s data, facilitating regulatory review. Read or listen to Issue 26 of The Altascientist to learn how.

QUICK LINKS

CASE STUDY—How Data Standardization Shortens Drug Approval Times

 

CDISC and SEND Simplify and Expedite Study Data Interpretation


Read The Altascientist and see how CDISC and SEND standards simplify and speed up analysis of your data, facilitating regulatory review and increasing your access to the power of big data. Includes two illustrative case studies and comprehensive FAQs.

Altascientist issue 26

Speak with an expert to learn more about our service offering.

Have five minutes? Take a look at these:

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.

 

 

Start Your Driving Trial Quickly—Simulators on Site

Driving simulator studies are a safe, efficient, and effective alternative to on-the-road driving trials for CNS-active drugs. The Altascientist dives into the requirements and technicalities of driving studies, and explains how driving simulation offers…

Faster study startup • Lower cost • No risk of property damage • No risk of injuries

… including a case study whose results were described as “reassuring” by the FDA.

Altasciences has conducted over 13,000 simulated drives in support of drug development.

Download as a PDF or listen to the audiobook, the choice is yours.

You may also be interested in the following:

Still Using Tablets in Your Clinical Trials? Consider Changing to a Better Option.

 

Accelerate Your Clinical Trials With This Dosage Form

With tablets presenting numerous drawbacks, liquid-filled capsules (LFCs) are becoming the optimal choice for clinical trials. Their benefits include:

  • Ease of scalability from preclinical to clinical to commercial volumes
  • Quick dose adjustments
  • Faster dissolution and absorption
  • Less required stability studies 

LFCs are most suitable for drugs with complex formulations, low-dose requirements, poor solubility, or highly potent active pharmaceutical ingredients (APIs). Clients with such drug profiles substantially accelerated their drug development process using LFCs for early phase clinical trials, resulting in reduced costs.

Where Do We Come In?

Altasciences’ state-of-the-art cGMP manufacturing and analytical facility in Philadelphia has a team of experienced scientists to support you through your entire drug development process, from pre-formulation to clinical trials and beyond. Our advanced equipment includes cutting-edge liquid-filling, binding, and sealing machines, ensuring an impressive 97% right-first-time (RFT) batch release success rate.

Consult our resources for further details on how you can benefit from using LFCs in your clinical trials.

eBooklet (PDF) Infographic (PDF) Quick Chat (Video) Client Case Study (PDF)
eBooklet (PDF) infographic (PDF) Quick Chat (video) Client Case Study (PDF)

Ready to accelerate your drug development? Speak with one of our experts.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

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