Advantages of Terminal Sterilization Over Aseptic Manufacturing

Regulatory agencies such as the FDA and EMA generally prefer terminal sterilization over aseptic manufacturing, as it provides a high level of sterility assurance. It is also less complex, less costly, more easily reproducible than aseptic manufacturing, and offers time savings to pharmaceutical companies.

In this issue of The Altascientist, we discuss:

• Differences between terminal sterilization and aseptic manufacturing 
• Sterilization methods for pharmaceutical products
• Validation steps during sterilization
• Method selection 

Read to learn how terminal sterilization can benefit your drug product. 

Questions? Speak with one of our experts? Contact Us.

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.  

You may also be interested in the following:

Webpages:

• Proactive Drug Development
• First-in-Human Trials

Fact Sheet:

• Comprehensive Research Support

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.

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.

You may also be interested in the following:

• Scientific Article: Maximizing drug formulations for first-in-human trials
• Webpage: Altasciences’ Pharmaceutical Contract Manufacturing and Analytical Services

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.