Newsletter | November 22, 2024

11.22.24 -- Pros And Cons Of Partnering With CDMOs Inside And Outside The US

SPONSOR

Webinar: Removing the Headache: Outsourced Stability Storage and Testing Solutions

Pharmaceutical and biotech companies must decide whether to outsource stability storage and testing or handle them in-house. Outsourcing offers cost savings, risk reduction, and compliance benefits. This webinar, featuring Darryl Souness and Stephen Delaney, will discuss risk mitigation, data quality, and cost management when outsourcing stability studies, along with best practices for protocol creation and risk assessment. Click here to learn more.

FEATURED EDITORIAL

Process Development: Stuck In The Middle With You

There’s so much pressure to accelerate programs out of research and into development. Despite the complexity of new drugs, therapies and technologies, process development chemists are then asked to quick-step to clinical grade and commercial-ready material. CDMOs overall need to move quickly at all stages.

Pros And Cons Of Partnering With CDMOs Inside And Outside The U.S.

Conrad Wüllerm MSc, Director of Strategy and Operations, ARTBIO, Sesha Neervannan, Ph.D., COO, Tarsus Pharmaceuticals, and Bethany Dudek, CTO, Arcutis, discuss the benefits and challenges of partnering with CDMOs in the U.S. and globally, and offer advice on mitigating supply chain risks.

INDUSTRY INSIGHTS

Powering Drug Development With Advanced AI Retrosynthetic Analysis Tools

Review advanced retrosynthetic analysis services and how these tools empower better, more efficient development of innovative small molecule drugs.

2025 And Beyond - A Look At Upcoming NDSRI Regulations

Learn from experts and secure reliable testing solutions to eliminate the presence of nitrosamine drug substance-related impurities (NDSRIs) in medications.

Nasal Inhalation Delivery – An Introduction Guide

Unlock the potential of nasal inhalation for delivering APIs by evaluating the advantages of both liquid and dry powder formulations as companies enhance local, systemic, and brain-targeted therapies.

Winning Strategies For Oral Dosage Form Development And Manufacturing

Failure to identify a compound’s red flags early in development often manifests as program delays or failures. Discover how to avoid these setbacks through complete molecular characterization.

Speed To Market – API Large-Scale Commercial Manufacturing

See how a top 20 U.S.-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

Tackling The Toughest Small Molecule Challenges

Accelerate your small molecule API program with a strategic CDMO partner with the experience, expertise, and flexibility required to solve the toughest small molecule challenges.

SPONSOR

The Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) welcomes to celebrate the 5th anniversary together on 14-15 April 2025 in Berlin, Germany. The closed-door Congress invites top-level management of pharmaceutical companies including supply chain and procurement experts, key packaging specialists, as well as CMOs and CDMOs. Bayer, Merck, Takeda, Ferrer, F. Hoffmann-La Roche, Produlab Pharma, Johnson & Johnson Innovative Medicine are already registered for participation.

SOLUTIONS

Nasal Spray Development And Manufacturing Services

A partner with experts who are adept at working with complex, sensitive, and potent APIs; screening for the optimal formulation; and scaling up efficiently is vital for successful trials and commercialization.

Comprehensive Regulatory Support

Our expertise spans across a wide range of global markets. Our experience in securing regulatory approvals and navigating market challenges positions us as a trusted partner.

Minitabs Technology

With high drug-loading capabilities and the option to combine with high-density formulations, MMTS™ is ideal for high-strength products. Experience the power of precision and flexibility with MMTS.

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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