Register or Sign in
to unlock feature

you are not authorized to read this article.

Login or register your account to get full access to the tableting technology platform.

Login Register
Please verify your account
Please confirm your email address to validate your registration. Follow the link on email received to verify your email adress.
Re-send verification email
Please complete your registration
You're logged in but you didn't complete your registration.
Complete my registration
Exclusive content

You are not authorized to read this article.

mystylone subscription is required to view this content.

Login Register
Close search
  • Resources
  • Products & Services
    • Compaction Simulators
    • R&D / Process Support
  • Events
  • About
  • Contact Us
  • Sign in
Resources
  1. Home /
  2. Resources /
  3. Newsfeeds /
  4. How to select the ideal HPAPI manufacturing partner
NEWSFEEDS

How to select the ideal HPAPI manufacturing partner

May 21, 2024
Remove from favorites
Add to favorites

The article discusses the challenges and strategies associated with safely manufacturing highly potent active pharmaceutical ingredients (HPAPIs). HPAPIs offer therapeutic benefits but pose risks to manufacturing personnel due to their potency. To ensure safety, manufacturers must employ containment measures and high-quality equipment. Occupational exposure banding (OEB) systems categorize the risk level of HPAPIs, guiding containment, process analytical techniques (PATs), and personal protective equipment (PPE) usage. Effective HPAPI handling involves training employees, establishing containment protocols, and implementing safety measures such as atmospheric monitoring and task risk analysis. Analytical techniques like near infrared (NIR) spectroscopy and Fourier-transform infrared (FTIR) spectroscopy aid in monitoring HPAPI processes. Choosing the right contract development and manufacturing organization (CDMO) involves assessing their experience, containment methods, analytical capabilities, and safety protocols. Partnering with a CDMO that prioritizes safety, offers customized solutions, and demonstrates expertise in HPAPI manufacturing ensures efficient and quality production for patient use.

Read more
Image - How to select the ideal HPAPI manufacturing partner
manufacturing potent
Contributor(s):
Share Copied!
Comments

No comments posted yet.

Add a comment

Articles you may like

Enabling end-to-end continuous manufacturing by API suspension feed and instantaneous drying in twin-screw wet granulation

Enabling end-to-end continuous manufacturing by API suspension feed and instantaneous drying in twin-screw wet granulation

first_published_at:May 16, 2018, midnight / date_published:May 16, 2018
Papers - 16/05/2018 - by Adrian Schmidt, Dr Jörg Breitkreutz, Peter Kleinebudde
For decades, pharmaceutical industries have relied on batch processes for manufacturing medicine. However, these current practices are deemed inefficient, lacking sustainability and long-term competitiveness. Continuous manufacturing is emerging as a …
Exploring the relationship between bulk Young’s Modulus of materials and milling efficiency during wet bead milling of pharmaceutical compounds

Exploring the relationship between bulk Young’s Modulus of materials and milling efficiency during wet bead milling of pharmaceutical compounds

first_published_at:June 21, 2024, midnight / date_published:June 21, 2024
Papers - 21/06/2024 - by Zahra Salahshoor, Parind M. Desai, Sayantan Chattoraj, Stephanie Lam
Wet bead milling (WBM) is a primary method for producing long-acting injectable (LAI) suspensions, where the particle size of an Active Pharmaceutical Ingredient (API) is reduced in a liquid vehicle …
illustration Exploring Best-Practice Manufacturing Strategies for Highly Potent Oral Solid Dosage Forms

Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms

first_published_at:Nov. 23, 2023, 2:43 p.m. / date_published:None
Newsfeeds - 23/11/2023 -
Exploring key points for manufacturing Highly Potent Oral Solid Dosage Forms:*Challenges of Highly Potent Oral Solid Dose (HPOSD) Manufacturing:The increasing development and market presence of highly potent oral solid dose …
More

Related products

illustration STYL'One Mist manual lubrication

Manual External Lubrication

MEDELPHARM
In development, external lubrication enables the characterization of the compaction behavior of pure APIs or …
material characterization

Material Characterization

Understand powder behavior to develop robust formulations. API characterization, excipient selection, and manufacturing process determination …
STYL'One Nano scientist powder zoom

On-site Training Program - STYL'One Nano

This 1-day program, conducted in your laboratory, incorporates classroom concepts, hands-on instruction, and interactive workshops …
STYL'One Nano scientist

In-house Training Program - STYL'One Nano

This 1.5-day program, conducted at MEDELPHARM Science Lab, incorporates classroom concepts, hands-on instruction, and interactive …
analis screen training

On-site Training Program - STYL'One Evo

This 2-to-3-day program, conducted in your laboratory, incorporates classroom concepts, hands-on instruction, and interactive workshops …
STYL'One Evo scientist

In-house Training Program - STYL'One Evo

This 3-day program, conducted at MEDELPHARM Science Lab, incorporates classroom concepts, hands-on instruction, and interactive …
tablet formulation development

Tablet Formulation Development

Understand powder behavior to develop robust formulations. API characterization, excipient selection, and manufacturing process determination …
scale-up support

Scale-up Support

Transfer R&D findings to production. Successful scale-up is key for tablet manufacturing efficiency. De-risk scale-up …
process optimization

Process Optimization

Successful process optimization is key for tablet manufacturing efficiency. Optimize your production process parameters with …
process troubleshooting

Process Troubleshooting

Successful troubleshooting is key for tablet manufacturing efficiency. Adjusting process parameters (compression speed, edge thickness, …
laptop laboratory gloves

Looking for additional information?

Let us help you

Contact our experts

GENERAL

  • Terms of service
  • Privacy Policy
  • Cookie Policy
  • About
  • Contact us

Account

  • Login

Follow us on

© 2025 Medelpharm