Drug Dev eBook Library
A Complete Guide to Aseptic Manufacturing eBook
Pii has released the first in a series of e-books about Aseptic Manufacturing, covering Aseptic Techniques and Sterilization Procedures.
You will learn how to:
- Overcome the challenges of a fill/finish tech transfer
- Integrate robotics into your fill/finish
- Select alternative primary packing options
- Implement protocols for aseptic procedures and sterilization techniques
- Choose the right CDMO partner for your aseptic manufacturing needs
AND get the answers to your FAQs about parenteral production, lyophilization, aseptic procedures, sterilization processes, sterilization techniques and cGMP practices.
The Parenteral Drug Delivery Market eBook
Pii is proud to offer its second Aseptic e-book with exclusive insight into the significant trends impacting Parenteral Drug Formulation and Manufacturing.
This follow-up report focuses on:
- Better understanding the characteristics of a parenteral drug
- Parenteral drug formulation and manufacturing keynotes
- Scale-up of parenteral drugs
- Primary packaging options
- Targeted treatments
Parenteral drugs are now accounting for almost half of all approved new molecular entities, due in large part to the role they play in treating chronic diseases as well as a rise in self-administration.
Lyophilization Trends in Pharma & Biopharma Drug Development eBook
Find out what is driving the lyo market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
In this exclusive Lyophilization e-book from Pii, you will learn how to:
- Achieve finished product lyophilization with limited API
- Ensure agile scale up
- Develop an Effective and Optimized Lyophilization Cycle
- Navigate Regulatory Demands
- Realize Quality Outcomes
- Overcome Stability Challenges
- Save Time and Costs
- Test and Select the Best Closure
- Determine Your Overall Lyophilization Needs
The Oral Dosage Drug Delivery Market eBook
As with every drug in development, there are many considerations. During the formulation process it is important to look at the substances involved, how and when to distribute the drug to the patient, total dose required, and how the patient will take the drug.
For orally administered drugs, three of the key considerations are solubility, bioavailability, and lipophilicity. These three factors affect the drug formulation, manufacturing, and the intended effect on various levels. It is important to understand how these factors are applied throughout the formulation development and clinical evaluation of an orally administered drug.