Newsletter | October 24, 2024

10.24.24 -- If The CDMO Shoe Fits, Wear It Now

NEW PODCAST EPISODE

Obesity Tx End-Around With Skye Bioscience's Punit Dhillon

While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant, Skye Bioscience CEO Punit Dhillon is confident that their antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics.

FEATURED EDITORIAL

If The CDMO Shoe Fits, Wear It Now

Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche

Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.

INDUSTRY INSIGHTS

Navigating A New Standard In Microbial Protein Expression

Recent advancements in genetic engineering, analytics, and screening reimagine E. coli as an “optimal” protein factory, not just a common one or an expression system artifact.

A New Mindset For Combination Product Development

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

3 Keys To Success When Planning With Your CMO Partner

Once you've identified a CMO partner, how do you ensure success? The secret: planning as early as possible – while your product is still in preclinical or clinical development.

Tips For Successfully Scaling From R&D To Manufacturing

By partnering with a trusted company that offers expertise in navigating the challenges of scale up, drug developers can have confidence in their ability to successfully bring their products to market.

Develop And Industrialize Novel Bacterial Strains At New Brisbane Facility

While the Brisbane facility’s key value is facilitating development and industrialization of new bacterial strains, how this is accomplished separates it from would-be competitors.

De-Risk Early Development Strategy: ADCs, Oligonucleotides, Radioconjugates

An experienced CDMO can empower developers to implement de-risking strategies that significantly improve both clinical and commercial outcomes for their biologic and bioconjugate programs.

Prioritizing R&D Initiatives To Support Cell Line Development

As drug discovery accelerates, so too does the need for robust cell line development. Learn how a CDMO that prioritizes R&D can help you unlock the potential for faster, more efficient development.

The Challenges Of Moving A Bioconjugate From Clinic To Market

Working with a partner that provides a one-stop shop for bioconjugate development and manufacturing helps prevent missteps that threaten the delivery of life-saving drugs to patients who need them.

Mastering Manufacturing Challenges: Lessons From A CDMO's EUA Project

Review a CDMO's strategy for overcoming challenges when acquiring new equipment for an Emergency Use Authorization (EUA) project and how leveraging existing resources and collaboration was key.

The Benefits Of Partnering With A CDMO Dedicated To Transparency, Analytics

Poland’s biomanufacturing scene presents an array of benefits for global partnership, including cost-effectiveness, economic stability, and a culture that emphasizes a strong work ethic.

SOLUTIONS

Large Molecule Manufacturing

Recombinant protein and plasmid DNA therapeutics and critical raw materials, including for vaccine and gene therapy applications, for the global market.

cGMP Manufacturing - Microbial System

See how our 4,000-square-foot cGMP manufacturing site is purpose-built to support your microbial program from pre-clinical to commercial manufacturing.

Cell Line Development

From vector construction to generating cell banks for GMP manufacturing following ICH and global regulatory requirements, we are the experts for all cell line development activities.

An Altogether Different CDMO Ready To Meet Your Needs

With expertise in clinical manufacturing, scale-up, cell cultures, API synthesis, and more, consider our end-to-end development services for pharmaceutical and biotech companies.

Frozen Packaging Solutions

Delve into how this partner's scalable packaging services for logistics support can achieve higher operational efficiency and lower quality and safety risks.

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.

Connect With Outsourced Pharma: