Newsletter | March 16, 2023

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

Featured Editorial
Industry Insights
Plan Your CDMO Search On A Foundation For Long-Term Success

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

10 Ways To Improve Your CDMO Partnerships

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

Vaccines: Cleaning Regulations For Production

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.

Developing A Disposable Grade-A Aseptic Fill/Finish Isolation System

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. 

Achieving Container Closure Integrity During Cryogenic Storage Conditions Using An Optimized Vial Stopper Combination

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

Key Considerations To Successful Project Management And Governance

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

Simplifying Outsourcing For Complex Formulations

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.

How Distributed Automation And DPM Support Resilient Biomanufacturing

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.

Partnering For Success In Sustained Drug Delivery Formulations

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

Aseptic Blow/Fill/Seal Technology Vs. Traditional Aseptic Processing

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

Continuous Flow/Batch Manufacturing Mix

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.

The Key Enablers Of Late-Phase Biologics Development And Launch

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.

Mitigating Risk In Tech Transfer: Expert Insights Into Finding The Right Partner

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.

Reduce Inhalation Burden With High-Dose, Carrier-Free Spray-Dry Powders

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.

A Toxicologist's Viewpoint On Developing Oncology Drug Products

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.

Coating: Curing Your Complex Oral Solid Dose Challenges

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.

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