Latest Publications
In The Press
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Best Practices Extend Beyond GLP for Investigational New Drug (IND) Enabling Studies
The development of any new drug or biologic [...]
Clinical Trial Material Manufacturing in an Age of Increasing Regulatory Oversight
Building a well-oiled clinical trial supply chain that [...]
Coating Processes in Commercial Tablet Manufacturing
The use of the medicinal tablet dates back [...]
Innovations in Lyophilization Cycle Development Challenge Assumptions and Improve Accuracy
Lyophilization was first developed in the 1940s, and [...]
New Advances in Preclinical Services May Help to Lower the Cost of Drug Development
Drug development is a long and expensive process, [...]
Sterile Powder Filling Presents Unique Challenges
The processing of lyophilized vials or any other [...]
The Pros and Cons of Closed-Vial Technology in Sterile Vial Filling
The increasing demand for parenteral products delivered in [...]
On-Going Research
Praesent lectus leo, convallis id neque nec, ultrices euismod nibh. Sed ac rhoncus quam. Fusce tristique tellus diam, vel porta eros iaculis vitae.
Best Practices Extend Beyond GLP for Investigational New Drug (IND) Enabling Studies
The development of any new drug or biologic requires extensive research and rigorous testing at every stage of the process. After the preliminary development and in vitro or in vivo testing, a proof of concept [...]
Clinical Trial Material Manufacturing in an Age of Increasing Regulatory Oversight
Building a well-oiled clinical trial supply chain that fulfills the requirements of Phase I and II pharmaceutical clinical trials does not happen by accident. It is universally understood that clinical trial material (CTM) manufacturing demands [...]
Coating Processes in Commercial Tablet Manufacturing
The use of the medicinal tablet dates back to ancient Egypt, making it one of the earliest pharmaceutical dosage forms. These solid compounds of active substances and excipients are often covered in some form of [...]
Innovations in Lyophilization Cycle Development Challenge Assumptions and Improve Accuracy
Lyophilization was first developed in the 1940s, and has been a mainstay of the pharmaceutical industry ever since. The fundamental free-drying methods are fairly straightforward and have remained relatively static over the decades, leading some [...]
New Advances in Preclinical Services May Help to Lower the Cost of Drug Development
Drug development is a long and expensive process, but new advances employed in preclinical services may help drug pipelines become faster, cheaper, and more effective. Developing a new drug or other medical intervention isn’t easy [...]
Sterile Powder Filling Presents Unique Challenges
The processing of lyophilized vials or any other parenteral product which takes the form of a sterile powder presents challenges that are not present in other sterile filling procedures. Many parenteral products and bulk drug [...]