Newsletter | January 30, 2025

01.30.25 -- How Biotech Academy In Rome Is Reshaping Workforce Readiness

SPONSOR

Webinar: Essential Considerations for Selecting the Right Biologic Fill/Finish Partner

Choosing the right Fill/Finish partner ensures drug safety and operational efficiency. A reliable partner minimizes risk, prevents contamination, and improves yield, ultimately saving costs. This webinar highlights four key questions to identify a quality-focused provider. Key takeaways include reducing risks while increasing yield, assessing partner quality, and understanding the value of an experienced partner in meeting therapeutic goals. Click here to learn more.

FEATURED EDITORIAL

How Biotech Academy In Rome Is Reshaping Workforce Readiness

As the biotech industry continues to evolve, a growing gap in workforce readiness has emerged, driven by insufficient training for new graduates and experienced professionals. Biotech Academy in Rome's Leonardo Sibilio addresses this challenge.

Regulatory Survey Shares Biotech Global Market Access Challenges, Learnings

To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

INDUSTRY INSIGHTS

Strategies To Achieve Successful Approval And Launch

Four experts share how scale-up, regulatory expectations, demand forecasting, and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.

What's Wrong With My Trial? Uncovering The Root Cause Of Clinical Trial Troubles

Discover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.

Guide To PUPSIT And Annex 1 In Aseptic Processing

Aseptic processing ensures drug sterility, with filter integrity testing being critical. PUPSIT, a regulatory requirement in the EU, ensures filters remain undamaged and effective during manufacturing.

The Stage-Gate Model: A Proven Approach To Streamline Biomanufacturing

Learn how a Stage-Gate approach to technology transfer and biomanufacturing can help to mitigate risk while shortening cycle times throughout the project lifecycle.

How Artificial Intelligence Is Advancing Biomanufacturing Excellence

Uncover how AI is transforming the biomanufacturing industry and how partnerships between pharmaceutical companies and academic institutions are poised to set the new standard.

Advantages Of A CDMO With Internal Biosafety Testing Capabilities

Here, we describe three biosafety testing methods: in vitro adventitious virus (IVV), species-specific virus testing such as minute virus of mice (MVM), and mycoplasma.

Navigating Primary Packaging Challenges, Solutions For Emerging Innovators

If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.

How Real-Time Data Access Enhances Collaboration With Your CDMO

Quality data for informed decision-making is well supported by a built-in network of lab digitization solutions and a commitment to the principles of data integrity.

Biomarker Selection And Measurement In Neurodegenerative Trials

Biomarkers are crucial for early diagnosis of neurodegenerative diseases. Learn about key protein biomarkers through an exploration of clinicopathologic correlations and measurement strategies.

SOLUTIONS

Finishing Services For Your Small Volume Labelling And Kitting Projects

Consider us for your labeling and re-labeling, secondary packaging, and kitting needs for preclinical studies, clinical trials, merger and acquisition activities, and blinded studies.

Mammalian Cell Culture: Process R&D Services

Our global R&D center for mammalian cell processes is based in the UK and sits alongside a custom manufacturing facility where we undertake highly specialized development and manufacturing services.

Parenteral Drug Formulation Development Process

Scaling your drug product from concept to commercial supply requires having the expertise to ask the right questions about your end goals, from the start.

Capacity Update July 2024: Large Molecule Development

Gain insights into boosting efficiency, fostering innovation, and how integrated capabilities generate value for innovators.

Capacity Update October 2024: Fill/Finish

Discover high-quality GMP manufacturing capabilities, featuring a state-of-the-art isolator-based filling platform and extensive fill-finish capacity for vials, syringes, and cartridges.

Capacity Update October 2024: ADC

Leverage our flexible solutions and access to proprietary CHO-K1 cell lines in our state-of-the-art cGMP suites equipped with single-use and traditional stainless steel bioreactors.

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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