Manufacturing and Analytical Services
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.
Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing
Nanomilling from Screening to Scale-up
Up Close and Personal with Ben Reed, BS, Executive General Manager, CDMO Services
Tailored Analytical Solutions for Fast Entry into Clinical Trials
Choosing the Right Partner for Your Formulation Needs
Altasciences’ extensive formulation and manufacturing services, integrated with our early phase drug development offering, spans across the full drug development pathway, from discovery through commercialization. Our scientists have decades of expertise with both simple and complex dosage forms, and a successful track record of formulating molecules and developing the drug products required to support early phase clinical trials.
Discover our full range of analytical services, including:
- Drug product release and stability testing
- Method development, qualification, and validation
- On-site, ICH stability storage and testing
Get a head start on your project ― speak with one of our scientists.
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing Services
- Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials
- 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.