ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway

  Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

• Rational Design And Development Of Long-Acting Injectable Dosage Forms

  The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

• Keys To Driving Consistent Quality In Contract Manufacturing

  Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.

• Pharmaceutical Nanotechnology: What To Know

  Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.

• Prefillable Syringe Plungers: A Solution For Low Temperature Storage

  Review a study with 1 mL long glass and polymer-based syringes and with 2.25 mL glass syringes. Explore the impacts on plunger movement, container closure integrity, and break loose and extrusion force.

• Successful Industrialization Requires Solid Foundations

  Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.

• Finding The Ideal Balance — Where Risk And Cost Of Quality Meet

  It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

• A Lifecycle Management Strategy For Sterile Injectables

  Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.

• Formulation Development From Preclinical To First-In-Human

  A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.

• Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells

  Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.