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1604, 2019

Clinical Trial Material Manufacturing in an Age of Increasing Regulatory Oversight

By |April 16th, 2019|Categories: Formulation Development & Clinical Trial Materials, Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

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 a commitment to Good Clinical Practice and current Good Manufacturing Practice (cGMP). These guidelines were [...]

704, 2019

Coating Processes in Commercial Tablet Manufacturing

By |April 7th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

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 superficial coating material. The application of a polymeric film or sugar coat to a tablet [...]

404, 2019

Innovations in Lyophilization Cycle Development Challenge Assumptions and Improve Accuracy

By |April 4th, 2019|Categories: Generic & Commercial Drug Manufacturing Services, Lyophilization|Tags: , , , , , , |0 Comments

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 in the industry to take lyophilization cycle development for granted. In fact, lyophilization is beguilingly [...]

2903, 2019

New Advances in Preclinical Services May Help to Lower the Cost of Drug Development

By |March 29th, 2019|Categories: Formulation Development & Clinical Trial Materials|Tags: , , |0 Comments

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 — or fast. In fact, it takes an average of around 12 years before a [...]

1603, 2019

Sterile Powder Filling Presents Unique Challenges

By |March 16th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , |0 Comments

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 ingredients are not stable in liquid or frozen form. Some naturally take a powder form [...]

1503, 2019

The Pros and Cons of Closed-Vial Technology in Sterile Vial Filling

By |March 15th, 2019|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , , |0 Comments

The increasing demand for parenteral products delivered in vials brings with in an increased demand for sterile vial filling — can closed-vial technology help manufacturers keep up? By the year 2021, the global market share for pharmaceutical products housed in vials and ampoules is expected to reach $12.4 billion, thanks [...]

2002, 2019

Sterility and Accountability in Ophthalmic Manufacturing of Eye Drops

By |February 20th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , , |0 Comments

Eye drops and other ophthalmic preparations are used by millions of individuals all over the world; in order to keep them safe and guarantee effectiveness, maintaining sterility is vital to proper ophthalmic manufacturing. Ophthalmic manufacturing; that is, the manufacturing of any preparations or applications intended to be used directly on [...]

1402, 2019

Risks and Rewards Associated with Developing Lyophilized Vials

By |February 14th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , |0 Comments

For transporting, storing, and handling drugs and other parenteral products that are unstable in solution, lyophilized vials remain the go-to solution for 80% of the industry. Today, approximately 16% of top pharmaceutical drugs--and 35% of biological drugs--are available in lyophilized vials, with Markets and Markets predicting that more than half [...]

702, 2019

Properties Affecting Homogeneity in Semi Solid Manufacturing

By |February 7th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|Tags: , , , |0 Comments

Semi solids such as creams, lotions, gels, and ointments require homogeneity in order to work properly, and maintaining proper homogeneity begins in the semi solid manufacturing process. Though semi solid products may not command the same share of the pharmaceutical marketplace as solid dosages and injectable medications, semi solid manufacturing [...]