The importance of working with a drug development and manufacturing consultant

In this podcast with Dr. Daniel E. Levy, we uncover the key considerations when putting together your drug development and manufacturing program, the importance of securing a drug development and manufacturing expert, and the most important things to look for in an integrated CRO/CDMO partner.

Listen to the podcast!

You may also be interested in the following:

WEBINAR ― Join Altasciences and Prince Terminal Sterilization for a complimentary webinar to find out why the FDA and EMA recommend terminal sterilization over aseptic manufacturing, and its many advantages for your drug products.

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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. Our experts in pharmaceutical contract manufacturing and analytical testing are ready to support you for formulation, method development and validation, clinical trial supply, and commercial batch manufacturing. We have tested or manufactured almost all available dosage forms on the market, including liquid- and powder-filled capsules, nano-milled suspensions, creams, gels, and terminally sterilized injectables.

Altasciences has become the go-to partner for pharmaceutical companies striving to develop safe and effective cannabidiol (CBD) products to address unmet medical needs. With our integrated early phase drug development solutions, we can quickly undertake formulation development and clinical manufacturing of next generation formulations with challenging APIs and controlled substances, such as CBD.

In this latest case study, our client (Emyria) presented the challenge of developing several oral formulation candidates for CBD from scratch for a new over-the-counter (OTC) product. Learn how we completed the entire project in just over three months!

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You may also be interested in: 

• Web page: Our Full Range of Manufacturing and Analytical Solutions
• Podcast: High Potency Manufacturing Solutions

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.

Altasciences’ New eSource Platform ⁠— ClinSpark^®

We are pleased to share that we have adopted the eSource platform ClinSpark^®, created by Foundry Health, to support our never-ending focus on compliance, efficiency, and oversight in data collection.

From recruitment to database lock, ClinSpark^® software will provide you, our valued clients, with access to your data in a fully validated system, compliant with 21 CFR Part 11.

We have successfully deployed the administrative recruitment portion of ClinSpark^®, as well as validated and deployed the clinic module. Ongoing trials being conducted in the clinic with a live database will still be performed by transcribing data from paper source documents into Medrio. Upcoming studies will be handled in ClinSpark^® as eSource and/or eCRF. Our study team will be in touch regarding any changes to your study.

A Frequently Asked Questions document is available here for your convenience.

The validation package is available electronically for client review and audit purposes, upon request. Please contact your Altasciences Project Manager should you wish to coordinate access to the validation documentation.

We are very excited to share this important milestone with you, and look forward to our continued partnership!

Sincerely,

The Altasciences Clinical Team


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.

Want to Start Your Nonhuman Primate Studies in Q3 2022? Here’s How.

Are you experiencing delays initiating your nonhuman primate (NHP) studies? We have the capacity, at our three preclinical sites, to start your studies two to three months following contracting, thanks to our steady supply of NHPs.  

At Altasciences, we do not rely on a single-source NHP supply chain. We remove the stress of sourcing research animals so that you can start your studies faster, with:

• Dedicated and diversified cynomolgus monkey supply agreements in place to allow for faster start-up timelines
• A continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facility 

You can schedule newly contracted NHP studies to start in Q3 2022 immediately.

Contact us to schedule your NHP studies today.

Have five minutes? Discover our extensive site capabilities:

• Webpage: Preclinical Testing Facilities
• Fact Sheet: Preclinical Services Capabilities
• The Altascientist: Planning Your Preclinical Assessment

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.

15^th Annual WRIB Meeting Recap on Immunogenicity

Have a look at these three scientific posters that were presented by our scientific experts at the 15th WRIB (Workshops on Recent Issues in Bioanalysis):
 

Dual Purpose of a Cell-Based Assay for an Agonist of the GLP-2 Receptor 
During drug development, cell-based assays are used for multiple purposes. These include early proof of concept to identify a drug product’s pharmacological activity, and further studies to determine whether neutralizing anti-drug antibodies (NAbs) are present.
Read more.
 

Development of an Oligonucleotide Drug Immunogenicity Assay: a Case for the Characterization of the Immune Response 
While the immunogenicity of protein-based biologics and the characteristics of the antibody responses directed against them are well understood, the same is not true for other categories of biologics.
Read more.
 

Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay
Selectivity evaluation for regulatory toxicokinetic (TK) quantitative ligand binding assays (LBAs) is required to meet accuracy requirements for at least 80% of the individual selectivity matrix lots.
Read more.
 

Through different techniques, our experts will help you determine the best possible approach for your molecule, and select the optimal platform to produce high-quality results. Book a consult with one of our experts to discuss how we can support your program.

You may also be interested in the following:

• Webpages:
  • Bioanalytical Services
  • Proactive Drug Development
• Podcast:
  • Three Laboratories ― One Vision, with Dr. Lynne Le Sauteur

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.

Miniature Swine Considerations for Your Next Nonclinical Program

Did you know that miniature swine is often a viable option for your nonclinical program?

This complimentary webinar discusses the scientific rationale for miniature swine model selection for your non-rodent, nonclinical programs. In addition, we present the different miniature swine strains which may affect your species selection process.

Speak with an expert to learn more about the possibility of utilizing miniature swine for your upcoming nonclinical drug development program.

Refer to these two guidance documents which can help with your species selection:

• Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)
• M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

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.