03.16.23 -- ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions

Capacity constraints typically are accompanied by other challenges, including missed timelines, defect rates, and overall decreased satisfaction with pharma companies’ bioprocessing CDMOs.

Explore what CDMOs are, why they’re necessary, and ten ways pharma companies can improve their partnerships — regardless of market conditions.

Learn about the critical cleaning and disinfection steps along with the associated regulations manufacturers take in their facilities to ensure product safety and the highest standards of product quality.

Flexible film isolation has been used in aseptic processing since the 1970s, but these systems tended to be a composite of stainless-steel chambers and airflow modules with a flexible film user interface. 

Here, we investigate possible primary packaging solutions for therapies requiring even colder storage temperatures down to cryogenic levels (-150 °C to -180 °C).

We review the four key elements to a capital project report: cost performance, schedule performance, risk management, and resource management.

In a recent webinar, experts from Ajinomoto Bio-Pharma Services explored the necessary components of a tech transfer for LNP-based drugs, including the outsourcing strategies needed to avoid pitfalls.

Embracing digital transformation, when combined with biomanufacturing best practices, supports increased productivity and efficiency in a biomanufacturing environment. Learn how distributed automation and digital plant maturity support resilient biomanufacturing.

With a focus on the sustained and controlled drug delivery segment of the pharmaceutical market, learn about technology platforms, support services, and sustainable solutions.

BFS technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

Many factors can necessitate a mix of continuous flow and batch manufacturing processes, which is often the first step toward multistep flow processes. Review two examples.

Dr. Claudia Müller answers questions from a webinar about the complex path to a successful product launch, which requires a holistic development strategy driven by a well-defined target product profile.

Establishing a relationship with a partner who has the right equipment, scientific expertise, and project management skills is crucial to mitigating risk in tech transfers — and, ultimately, controlling costs.

Explore how spray-dried particles provide an attractive, carrier-free option for highly dispersed delivery of API to deep lung regions, utilizing an alternative approach to large, porous particles.

Since oncology drugs are commonly categorized as highly potent, they require various handling and safety strategies. Toxicologist Joe Galati discusses criteria for evaluating highly potent small molecules.

Oral solid dose experts discuss how advances in the mathematics and engineering involved in the process can be used to tackle challenges and ensure functional coating and drug layering continue to be a viable solution for the next generation of OSD drug products.