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Blog2018-03-04T18:00:46+00:00
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 [...]

1701, 2019

Reducing Contamination in Parenteral Manufacturing

By |January 17th, 2019|Categories: Generic & Commercial Drug Manufacturing Services|0 Comments

Emphasizing quality and compliance through every step of the manufacturing process helps to ensure the safety and consistency of parenteral products. Manufacturing parenteral products--from prefilled syringes and single-use vials to premixed IV bags and beyond--offers unique challenges, including growing pressure from competitors and patients and the stringent needs of regulatory [...]

911, 2018

Manufacturing of Capsules Requires Formulation Adaptations

By |November 9th, 2018|Categories: Formulation Development & Clinical Trial Materials|0 Comments

APIs, excipients, capsule materials and production methods should all complement one another in order to prevent difficulties. Whether a drug formulation exists as a liquid, granule or gel, capsules can serve as a useful oral dosage form. They combine the advantages of tablets, in that they are easy for patients [...]

611, 2018

Crucial Steps For Obtaining Medical Device Regulatory Compliance

By |November 6th, 2018|Categories: Preclinical|Tags: , |0 Comments

By aligning the many interlocking parts of the design process, manufacturers can greatly increase the likelihood of regulatory approval. The invention of a medical device is only the first step in the process of determining its clinical and commercial viability. From the moment a manufacturer selects a device to develop, [...]

507, 2018

5 Key Challenges in Medical Device Preclinical Testing

By |July 5th, 2018|Categories: Preclinical|Tags: , |0 Comments

The engineering of a medical device constitutes only one aspect of its viability. In order to obtain regulatory approval, a device also needs to comply with biocompatibility and sterilization standards. Raw materials, packaging, and design may all impact a device’s safety and compatibility, and a preclinical assessment of all these [...]

1506, 2018

Preformulation

By |June 15th, 2018|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

A clear understanding of a drug’s chemical properties will lead to a better formulation design. Before a formulation is developed around an active pharmaceutical ingredient (API), that API itself must be clearly understood. A careful analysis of the solubility, stability and other chemical properties of a newly discovered API will [...]

606, 2018

Clinical Trial Material Manufacturing

By |June 6th, 2018|Categories: Formulation Development & Clinical Trial Materials|Tags: , , , , |0 Comments

Logistical challenges demand close collaboration from the early stages of the development process. Some fundamental requirements apply to all clinical trial supply chains. Manufacturing facilities must comply with Good Manufacturing Practice (GMP) guidelines, including effective sterilization and cold chain management. Formulations must be screened regularly for quality, and containers must [...]