Manufacturing and Analytical Services
Start Your Clinical Trials Sooner
Our clinical trial experts set your drug development program up for success by proactively preparing and performing each critical moving part while others are underway. As a single source for early phase drug development solutions, we integrate and synchronize key CRO/CDMO activities, such as clinic-ready manufacturing, bioanalysis, clinical study conduct, and regulatory review, so that you’re always ready for the next step.
Check out how we do this and experience the difference.
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Webpages:
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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Psychedelics — Regulatory Environment Challenges
A History of Public Attitude Towards Psychedelic Drugs
Psychedelic drugs exist within a unique social, legal, and historical environment, with roots in the public imag
How to Overcome Formulation Challenges in Drug Development
Over 80% of drugs will fail during clinical development ― formulation challenges and lack of efficacy being the major causes.
How do we overcome these challenges?
Altasciences’ integrated approach combines formulation development for preclinical and clinical studies, analytical assay development and validation, excipient screening, GMP manufacturing, as well as finished product and release testing ― seamlessly transitioning your project from R&D to clinical supply.
Our expertise includes:
- Scale-up and clinical/commercial manufacturing of drug products with complex formulations
- Developing and manufacturing of liquid-filled, hard-shell capsules required for poorly soluble molecules and difficult formulations
- Handling of potent compounds and controlled substances (Schedules I-V), with expertise in cannabinoids and psychedelic/hallucinogenic drugs
- Manufacturing of wet nanomilled suspensions with scales up to 2,000 L
By partnering with Altasciences, you will:
- Reduce your timelines
- Improve and accelerate critical decision making
- Minimize risk of product failure
Trust your drug product development to a reliable, experienced CDMO.
Contact us.
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Your CDMO Partner – From Formulation to Commercialization
In an industry where there is no shortage of drug development and manufacturing partners, you may ask:
WHY ALTASCIENCES?
Here are a few reasons:
- We are highly skilled in handling complex formulations and highly potent compounds, and have tested or manufactured a wide variety of dosage forms.
- We offer significant expertise in the production of liquid-filled capsules, using cutting-edge technology for an exceptionally high “Right First Time” rate in releasing quality batches.
- We can resolve your solubility and bioavailability challenges with techniques such as nanomilling.
- We offer fully integrated, end-to-end solutions, from discovery to preclinical to clinical proof of concept, and beyond. You will benefit from working with one partner to get your drug product to clinic, faster.
Watch to learn more on our expertise and how we can accelerate your drug development program.
Interested in speaking with one of our experts? Contact Us.
Quickly Advance Your Highly Potent API From Concept to Commercialization
Approximately 25 % of drugs in development worldwide are classified as highly potent active pharmaceutical ingredients (HPAPIs), and present substantial challenges and safety concerns to the pharmaceutical manufacturing industry.
At Altasciences, handling and developing HPAPIs into finished drug product, such as anti-cancer compounds and narcotics, is one of our core strengths. Our unique expertise, segregated grade C/D clean rooms, safety procedures, and advanced technology allow us to take your potent compounds from concept to commercial scale manufacturing, safely.
Learn more about our HPAPI handling and manufacturing capabilities here.
Need help with your HPAPI?
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Let’s Talk Integrated Clinical and CDMO Solutions
Quality and Excellence with Integrated Clinical and CDMO Solutions
Shawn Connaghan, Executive Vice President of Administration and Quality Management, Manufacturing, discusses how Altasciences’ integrated manufacturing and clinical solutions can benefit your drug development program.
Topics covered:
- Advantages of integrated manufacturing and clinical solutions
- Quick project start-up
- Maintaining high-quality standards
- Adapting to sponsors’ unique needs
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
- Webinar: High Potency Manufacturing Solutions
- Webpage: Clinical Trial Services
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
How Nano Milling Saved Our Client’s Poorly Soluble Compound
Case Study: Nano Milling from Screening to Scale-Up
Have you ever had a challenging API with poor water solubility and bioavailability, and didn’t know how to improve the formulation? Our client did, and they came to us for help!
Download our case study to learn how Altasciences determined the suitability of nano milling to increase the drug’s dissolution rate and bioavailability, making sure our client had it ready on time for their first-in-human clinical trial.
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
- White Paper: Utilizing Nano Particulate Formulations in the Delivery of Poorly Soluble Drugs
- Webpage: Clinical Trial Services
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.
Expert Support for Your IND/CTA Requirements
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Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.
For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.
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Are You Using the Right Dosage Form for Your API?
Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing
Liquid-filled, hard-shell capsules (LFCs) offer significant benefits for APIs that present formulation or manufacturing challenges. They are also an attractive option for sustained release products, line extensions, and brand differentiation. Their use is beneficial throughout the different phases of drug development, from preclinical to commercialization.
Download our white paper to learn more on the process of liquid-filled capsule manufacturing, and to find out if LFCs are the right choice for your API.
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
- Video: Benefits of Liquid-Filled Capsule Manufacturing
- Webpage: Comprehensive Clinical Trial Services
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.