Newsletter | September 20, 2024

09.20.24 -- The High Life And Times Of A Qualified Person (QP) In Europe

SPONSOR

Webinar: Enabled Form Selection for Oral Drug Products Using a Combination of In-Silico Modeling and In-Vitro Measurements

This webinar highlights the use of PBPK modeling software like GastroPlus® to simulate drug properties and interactions, reducing unnecessary testing. We'll cover solid form screening, formulation maps for amorphous solid dispersions, and criteria for salt screening, emphasizing how these tools can guide early drug form selection and enhance bioavailability. Register now to learn more.

FEATURED EDITORIAL

The High Life And Times Of A Qualified Person (QP) In Europe

You must be appropriately qualified, trained, accepted by the relevant competent authority in the European Union, and named on a site’s authorization. According to Nolliag Buckley, a Qualified Person (QP) also needs more. “Honest to God, you must be creative. That sort of individual skill is helpful. I'm a troubleshooter. That's what I love.”

Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR

Content uniformity is one of the most important release criteria for solid dosage forms. In continuous manufacturing, what process analytical technologies (PAT) are available to measure and assure content uniformity as part of a real time release (RTR) strategy?

Marriage Or Roofing Contractor? Metaphors For Outsourcing

Chief Editor Louis Garguilo instigates a bit of philosophic thought in panelists Sriram Naganathan, REVOLUTION Biologics, and Kirsteen Keith, Immunocore, when it comes to strategic alliances with CDMOs.

INDUSTRY INSIGHTS

The Future Of Small And Large Molecule Bioanalytics

Learn how innovative, emerging technologies are revolutionizing the field of bioanalytics and drug development.

The 3 Cs You Should Expect From Your Pharma Service Provider

We share important factors to consider when weighing your contract service provider options. These “Three Cs” can indicate whether a provider has the capabilities desired by sponsors.

Building A Greener Future With Sustainable Manufacturing Practices

As the pharmaceutical fine chemicals industry strives towards sustainable innovation, CDMOs are considering how best to implement process adaptations, renewable raw materials, and green chemistry to reduce carbon footprints.

Approaching IND: What To Consider In Early Development

When preparing for IND submission, developers must consider multiple components. Explore tips for optimizing your early development program and the benefits of housing all activities under one roof.

Integrated FiH Services To Streamline Development And Manufacturing

An optimized service offering can simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.

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Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

SOLUTIONS

Grace's Fine Chemical Manufacturing Services: R&D From Concept To Commercial

Grace's FCMS offers comprehensive research and development services and is equipped to handle all your product development needs and bring your projects from concept to production.

Understanding Options In Direct-To-Patient Clinical Supply

Learn how DTP clinical supply enables participants to receive treatments in the comfort of their own homes while reducing the need to travel to a clinical site.

Large-Scale API Production Services

Ensuring commercial success at every juncture, we employ a consultative and phase-appropriate methodology that's tailored to your specific needs.

Packaging Design And Development Services

We are manufacturing, packaging, and supply chain experts, harnessing experience and expertise to deliver you a seamless solution with the ultimate aim of improving the lives of patients.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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