Newsletter | April 14, 2025

04.14.25 -- The Unsung Influencer: Why Your CDMO BD Contact Matters More Than You Think

SPONSOR

We know how tough it can be to find the right CDMO, especially when capacity is tight and timelines are critical. That's why we're bringing together 31 CDMOs for our Outsourced Pharma Capacity Update Partners Week — a chance to explore their latest capabilities and available capacity, all from the convenience of your screen. Learn more about our sessions grouped by modality to join us to find the right partner for your project.

INDUSTRY INSIGHTS

ICH Q14 101: Applying AQbD To CMC For Regulatory Success

ICH Q14 provides comprehensive guidance on analytical procedure development, offering an invaluable framework for ensuring the development of regulatorily compliant analytical procedures.

4 Questions To Ask Your Fill/Finish Partner

Identifying a fill finish provider with the right capabilities starts with asking these four questions, which, with the right partner, will yield the following complex, well-considered answers.

Predictive Modeling Of Viscosity Behavior Using Artificial Neural Networks

Discover a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

FEATURED EDITORIAL

The Unsung Influencer: Why Your CDMO BD Contact Matters More Than You Think

You want the best shot at a successful CDMO selection, and subsequent relationship – one that thrives during the good times, and survives the stress of development and manufacturing challenges? Your CDMO’s business development (BD) professional is a good place to focus.

Questions You And Your New CDMO Might Be Asking

One expert who has been on both sides of contracting relationships explores common questions you could — or should — be asking before signing up with a new manufacturer.

INDUSTRY INSIGHTS CONTINUED

Embrace A Contract Manufacturer Partnership That Drives Sustainability

Medtech OEMs, contract manufacturers, and other partners involved in the device life cycle are increasingly realizing additional benefits by making sustainability a group exercise.

Using Novel Biological Responses For Robust Cell-Based Potency Assays

Ensure the potency and efficacy of your biologic products with Catalent's GMP-compliant potency bioassay, offering accurate real-time assessments for GMP release and stability testing.

Sterilizing Grade Filter Performance With Biologic Drugs

Examine the throughput performance of sterilizing grade filters across moderate-to-high concentrations of mAbs and immunoglobulins as well as how filter selection can impact your process.

Combining An MVA Technology Platform With Innovative Analytical Methods

Learn how this process development platform for MVA impacts vaccine manufacturing and supports the drug life cycle from process and analytical development through trials and commercialization.

3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

Multi-Attribute Method Analysis In Biopharmaceutical Development

Analytics is a crucial element in biopharmaceutical development and manufacturing. Discover how Multi-Attribute Method (MAM) revolutionizes analytics to enhance quality control and regulatory compliance.

Scale Your Vaccine Development With Path-To-PAD

Delve into the details of this straightforward approach to maximize yields early in development, leveraging vaccine expertise, robust platforms, and Vero and Quail cell lines.

SOLUTIONS

Tour A Large Scale Cell Culture Facility In Vienna

With cutting-edge innovations like smart glasses for live process insights and a data-sharing portal, we're able to provide the capacity and expertise to bring biologics to commercial success.

Capacity Update January 2025: Large Molecule Development

Follow along as Derek Ryan, Sr. Director of Analytical Development, showcases our high-throughput technology and digital tools for process understanding and optimizing decision-making.

A Reliable CDMO That Can Make What Matters

You can count on our extensive scientific and manufacturing expertise, stringent quality standards, and highly responsive customer service to ensure timely delivery of your life-changing products.

Unraveling ADC Complexities With Bio-Logic Brilliance

We use our bio-logic brilliance to unravel the complexities of ADCs — empowering companies to accelerate development, enhance manufacturing efficiency, and deliver life-changing therapies.

Our Biotech Success — Levicept

Simon Westbrook formed Levicept to develop an idea for a complex fusion chimera protein he believed could interrupt the neurotrophin pathway, and being a true virtual company, he needed a CDMO.

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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