Newsletter | September 10, 2025

09.10.25 -- Paying For Lots Of Formulation Work At Your CDMO

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Handling Protocols: Considerations For Highly Potent API

Explore the growing role of highly potent active pharmaceutical ingredients (HPAPIs) in the development of targeted therapies, particularly in oncology and in the Antibody-Drug Conjugate (ADC) market. While these compounds offer significant opportunities, the manufacturing of HPAPIs presents several challenges especially about handling and safety protocols. Collaborating with a specialized and experienced CDMO partner is crucial to navigate complexities safely and ensure success of your program. Learn more.

INDUSTRY INSIGHTS

The Compliance Risks Of Disconnected Automation Systems

Isolated automation systems fragment critical data and slow key processes. Learn how an integrated approach can build a more cohesive, compliant, and efficient automation landscape.

Critical Supply Strategies For CROs

Leveraging the expertise of a chosen clinical supply partner can be a valuable resource. Examine key considerations when partnering with a CRO in order to deliver a successful clinical supply strategy.

How To Optimize CMC And Clinical Strategies For Injectable, Oral Peptide Drugs

Advances in peptide drug delivery have opened new opportunities for peptide drug products, with non-parenteral routes of administration — such as oral and nasal — now feasible.

FEATURED EDITORIAL

Paying For Lots Of Formulation Work At Your CDMO

We’ve investigated the outsourcing of early-to-commercial drug formulation strategies. So how do you pay for all that work? For specific answers and examples, once again Chief Editor Louis Garguilo primarily turns to Dileep Boinipally at Metsura. He starts with the "usual method of payments" - fee-for-service (FFS), but adds plenty of options and strategies.

EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance

The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

INDUSTRY INSIGHTS CONTINUED

Speed To Market – API Large-Scale Commercial Manufacturing

Learn how a top 20 US-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.

4 Things To Consider In Pharmaceutical Labeling

Pharmaceutical labeling demands precision. Examine key considerations for ensuring accuracy and efficiency in your process, from robust control systems to diverse printing options.

Simultaneous Spray Drying For Large/Small Mol Combinations

Gain insights into a “simul-spray” process pioneering for combining small and large molecules into a single, atomized drug product for inhalation administration.

Indiana Pharmaceutical Companies Where Innovation Meets Community

Explore how Indiana’s growing pharmaceutical sector — and globally connected CDMOs — are redefining where innovation in drug development truly happens.

SOLUTIONS

Nasal Dosage Form Development

UpperNose™ aims to facilitate the development of molecules, ensuring a smooth transition from early-stage development to clinical trials.

Comprehensive Regulatory Support

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

The Team For Your Package Design Needs

Our dedicated team of in-house design specialists deliver insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions.

Quality Control Services

With extensive industry experience in both large and small molecule parenteral drug testing, we can effectively manage your API, drug substance, and drug product stability study programs.

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: