Manufacturing and Analytical Services
Small Molecule, Nonclinical Drug Development Solutions
As your drug development partner, we have a deep appreciation of both the challenges and the potential of your small molecule. At Altasciences, we understand why developing your molecule requires tailored solutions at every stage.
Find out how our small molecule solutions help identify new and improved approaches to study designs, and anticipate development challenges as studies evolve.
Bring us your challenge. We have the solution.
You may also be interested in the following:
- Factsheet: Small Molecule Safety Assessment
- IND/CTA Guide: Planning your Preclinical Assessment
- Webpage: Bioanalytical 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.
Securing VC Funding and Drug Manufacturing Consulting
Consultant Series ― Interview with Teresa Johnk
Listen in as we discuss the role of a strategic business development consultant in drug development with industry veteran Teresa Johnk, Founder and CEO of BioPharma Connections.
In this podcast, we uncover:
- Important considerations to secure VC funding
- How to ensure the successful program completion
- What to look for in a consultant
- What to look for in a CRO/CDMO partner
Connect with our industry experts.
You may also be interested in the following:
- Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials
- Factsheet: Manufacturing and Analytical Services
- Webpage: Full-Time Equivalent (FTE) Capabilities
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.
25+ Years’ Experience Conducting Early Phase Drug Development
One of the most significant milestones in drug development research is the transition from preclinical to clinical studies. Ensuring risk mitigation at all steps of preclinical and clinical testing, as well as incorporating a thorough safety review plan in the clinical setting, is integral.
Altasciences applies recommendations from world-wide regulatory agencies to ensure that studies are conducted safely, ethically, and in a scientifically robust manner.
We facilitate drug development and save you time by:
- Preparing your preclinical study designs, including species selection and dose level determination.
- Conducting the required safety testing and updating your Investigational Brochure while your IND/CTA-enabling studies are in progress.
- Writing your IND/CTA applications.
- Planning your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human (FIH) trials as soon as you receive regulatory approval.
- Designing your FIH clinical protocol using preclinical study data, including identifying the maximum safe starting doses.
- Timing small-scale drug formulations with clinical conduct to get your trials started sooner.
- Conducting your FIH trials and making quick, informed dosing decisions based on timed bioanalytical data and safety data available within 48 hours.
- Quickly identifying trial findings that may allow you to waive certain studies or provide critical data for safety/dosing considerations in subsequent clinical studies.
Our preclinical, manufacturing, bioanalytical, and clinical teams work closely together to transition drugs through the critical early phases of drug development.
Speak with our experts.
You may also be interested in the following:
- Video: Your Road to Proactive Drug Development with Altasciences
- Webpage: Scientific, Regulatory and Strategic Guidance
- Webpage: Full-Time Equivalent (FTE) Capabilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
Formulation Development Services
Altasciences offers extensive and comprehensive formulation development services for your preclinical toxicology programs.
Our Analytical Chemistry experts regularly develop a vast array of formulation types (for both oral and parenteral administration) and offer a comprehensive package of formulation development from preformulation investigations, formulation validations, stability assessments, compatibility (e.g., with filters and catheters), and assessment of suitability with dosing apparatus. A combination of our formulation expertise, knowledge of vehicle suitability in preclinical models and close collaboration with our toxicologists ensures the development of a vast array of formulation types suitable for preclinical programs.
Oral
- Solutions
- Suspensions
- Emulsions
- Pills
Parenteral
- Intravenous (bolus and continuous)
- Subcutaneous
- Intraperitoneal
- Intramuscular
- Intravitreal
Download our one-pager to learn more.
Contact our scientists for a customized experience.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether 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.
You may also be interested in the following:
Fact Sheet:
Providing you with Cost-Saving and Quality Liquid-Filled Capsule Solutions
Our state-of-the-art equipment train and highly trained operators ensures that we can successfully deliver your liquid-filled capsule projects – simple or complex, large or small scale.
In this short video, our Vice President of Manufacturing, brings you inside our 30,000‑square‑foot, purpose-built, FDA‑inspected cGMP facility to provide you with a preview of our liquid-filled capsule manufacturing suite in Philadelphia, PA.
Contact us today for access to our full CDMO virtual facility tour video.
You may also be interested in the following:
Setting the Foundation for Quality and Expertise in Drug Manufacturing
With the manufacturing and analytical capabilities to produce Schedule I to V products, Altasciences helps you accelerate your drug development program without compromising quality.
In this interview, Ben W. Reed, Vice President of Manufacturing, discusses Altasciences' unique drug manufacturing capabilities, talent acquisition, and running niche programs.
Do you have questions? Speak to an expert.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single service or a synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept and beyond.
You may also be interested in the following:
- On-Demand Webinar: Liquid-filled Capsule Expertise
- Case Study: Altasciences Fills Need of Leading Cancer Therapeutic Drug Developer
- Video Podcast: Overview of Manufacturing Capabilities
Releasing Quality Batches Successfully… The First Time
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You can depend on Altasciences’ highly skilled team to meet the requirements of even your most complex pharmaceutical manufacturing projects. We have the training programs in place to ensure our team completes your project to the highest industry standards. We pride ourselves in releasing quality batches successfully the first time. |
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Our operators are more than just 9 to 5 employees — they are invested in your product. To learn more about our CDMO skilled workforce, contact our experts today. Altasciences’ CDMO site provides pharmaceutical contract development manufacturing and analytical services, including formulation development, Phase I through commercial manufacturing, and ICH stability testing. |
Improving Solubility of Molecules via Nanomilling
Bioavailability Considerations
The formulation of an active pharmaceutical ingredient (API) to ensure maximum bioavailability is central to successful drug development.
Benefits of Nanomilling
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Nanomilling is an effective, reproducible process that is extremely scalable. One of the biggest benefits of nanomilling when compared to other formulation methods for poorly water-soluble APIs is its universality. While nanomilling is very useful for APIs with solubility below 200 µg/mL, it can easily be used for most insoluble APIs, making it an attractive, first-line method to solubilization. Altasciences is equipped with a state-of-the-art equipment train, including a Netzsch DeltaVita 15-300 Mill, for the wet milling of API. |
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Altasciences has decades of experience developing nanosuspensions from scratch. If you have an insoluble API, contact us to learn how nanomilling can be the solution you need. |
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