02.11.25 -- 2024 Trends In FDA Observations For Sterile Drug Manufacturers

Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

Explore strategies for maximizing ROI in pharma through advanced analytics, streamlined operations, and an interconnected data management platform.

Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives. Learn more here.

There are two primary filling methods for pre-filled syringes. Explore the pros and cons of each approach and why barrel filling is generally preferred in the pharmaceutical industry.

Many factors should be considered when tasked with acquiring the equipment needed to run a pharma facility. Being aware of every upfront cost is a must when determining optimal equipment ownership.

Discover how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.

The need for advanced safety measures and reliable manufacturing technologies is critical. It is essential to partner with an experienced HPAPI manufacturer for safe and successful product development.

Delve into an integrated drug substance and product CMC strategy for novel molecular formats, other recombinant proteins, and tailored, product-specific solutions that enable acceleration into the clinic.

Technology has led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies used today.

Considering an approach that ensures compliance while reducing the likelihood of errors and discrepancies? Learn more about a solution that delivers near-real-time data insights.

Cryopreservation is essential for storing stem and T cells for therapy but poses challenges like low survival and function loss. Watch to explore optimization strategies and solutions.

CMOs and CPOs currently face significant challenges, including strong competition, high-cost pressure, and more. Discover why being agile, flexible, and responsive is bound to pay off.

Reducing the carbon footprint of your pharmaceutical fine chemicals manufacturing process requires a shift from the traditional approach. Sustainability requires revolutionary changes.