Newsletter | July 8, 2024

07.08.24 -- So You Want To Be An Outsourcing-Industry Entrepreneur?

SPONSOR

Tech Transfer strategies and best practices to optimize your clinical and commercial supply

Tech Transfers for biological products are complex, challenging processes. Join us on July 11th for an insightful webinar on the critical aspects of technology transfer of either drug substance or drug product. This session will delve into the strategies and best practices for seamless tech transfer processes, ensuring regulatory compliance, and maintaining product quality and consistency. Click here to learn more.

FEATURED EDITORIAL

So You Want To Be An Outsourcing-Industry Entrepreneur?

Secretly, somewhere inside you, is the thought: I’d like to leave this job at my established biopharma company. You wonder: How would I start my own, wait for it: contract service organization? Jeffrey Kiplinger, formerly of Pfizer, did just that. And wrote a book about it.  

The Growing Demand And Applications For HPLC

High-performance liquid chromatography offers more features compared to other analytical techniques, and the industry is finding more valuable ways to use it.

Outsourcing Not Plug-And-Play

Joanne Beck, Chief Technology Officer, Aerium Therapeutics, starts our Outsourced Pharma Live with a caution: Working with CDMOs is less like a plug-and-play model, and more like a custom-fit set of activities.

INDUSTRY INSIGHTS

Set Your Oversight Early, But Do Not Dictate All The Rules

As more and more sponsors leverage CDMOs' expertise and capabilities, utilizing the right framework to manage a partner is crucial for the relationship to function optimally.

Transitioning From Research To Drug Formulation And Development

The transition from academic research and studies to industry research demands that individuals master additional skills, set different objectives, and define “success” differently.

Using Advanced Mass Spectrometry To Analyze APIs And Impurities

Characterizing impurities through advanced analytics, including mass spectrometry, is a critical step in ensuring biotherapeutic product quality. Learn more about the growing role of CDMOs in developing these products.

Harnessing Analytical Development To Ensure Successful Manufacturing

This presentation addresses the critical need for high-throughput, reliable analytical development strategies to support expedited Investigational New Drug (IND) applications.

Partnership Goals For Scale-Up Success

As demand for capabilities and resources grows throughout a project, both become strained in-house and the scale-up process becomes a steeper hill to climb.

Advancing Early-Stage Bispecific Discovery Programs Towards Clinical Success

Jin Lu, Ph.D., Senior Technical Support Manager, shares how novel expression tools can advance your bispecific antibody discovery programs.

Tackling Antimicrobial Resistance

Learn how companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.

The Critical Role Of Comparative Analytical Assessments

Utilizing expert analytical testing services can unlock the potential of biosimilars and bring cost-effective treatments to market faster.

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

SPONSOR

Not really into choosing extended time away and exhibit halls over the simple pleasures of summertime? No reason to put your CDMO search on hold – Outsourced Pharma Capacity Update’s PARTNER WEEK is here! Take the travel and headache out of your plans and join us right from your computer. Assess potential fit for your next drug development project in convenient 20-minute segments – all grouped by molecule type. Presenters will share current available capacity across featured capabilities. Register for free.

SOLUTIONS

Combining Scientific Knowledge And Advanced Technology

Explore our contract production and development using the end-to-end business model. We specialize in the production of sterile biotechnological products in a manufacturing plant that meets the requirements of GMP.

Get Your Biologic To Clinic And Market Faster

We are your one integrated partner with the expertise to get your therapeutic product to market faster, helping you accelerate, simplify, and de-risk your biologics.

Our Biotech Success - Surrozen

Surrozen was keen to get started on process development and manufacturing and needed a CDMO with experience developing and producing BsAbs and fusion proteins.

The Leading Bioconjugate And Complex Biologics CDMO

We offer comprehensive support for complex biologic drug candidates and bioconjugates, encompassing everything from discovery through developability assessment, lead selection, and optimization.

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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