Newsletter | March 27, 2026

03.27.26 -- Advising The Biotech C-Suite To Reconsider Quality

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Join us for two Outsourced Pharma Capabilities Update sessions featuring leading CDMOs sharing their facilities, timelines, and available capacity for development and manufacturing. The April 21st session focuses on small molecule drug product capabilities, while April 22nd highlights fill-finish technologies including sterile filling, lyophilization, and advanced packaging. Expect short digital presentations to help biopharma companies identify partners that can meet their manufacturing needs. Click to learn more.

INDUSTRY INSIGHTS

Practical Playbook For The Manual Assembly Of Combination Products

Manual assembly is key in early-phase combination product development. Strong process design, collaboration, and quality controls reduce risk and ensure consistent progress toward manufacturing.

The Art And Science Of Topical Formulations

Chief Scientific Officer Jon Lenn discusses the balance of art and science in topical formulation development, emphasizing advanced skin models for optimized delivery, activity, and product stability.

Nanomilling: Enhancing Drug Solubility And Bioavailability

Transform poorly soluble drugs with nanomilling to enhance dissolution, boost bioavailability, and enable scalable, high-performance formulations across multiple delivery routes.

FEATURED EDITORIAL

Advising The Biotech C-Suite To Reconsider Quality

“I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

The Firefighting Era Of Clinical Supply Chain Is Over. Here's What Replaces It

Clinical trial supply chains are evolving: digital twins, on-demand kits, and sustainable logistics replace reactive firefighting with precision, speed, and resilience.

INDUSTRY INSIGHTS CONTINUED

Advantages Of Localized OSF Production

Discover how localized OSD development and manufacturing in Europe can help pharmaceutical companies navigate complexity, strengthen supply chains, and scale to meet market demands.

Enabled Form Selection For Oral Drug Products

Review the role of solid form screening and PBPK modeling to enable accelerated timelines desirable in early-phase drug development. Explore formulation maps for ASDs and key criteria for salt screening.

The Importance Of Tablet Density Uniformity

Non-uniform density causes many tablet failures. Learn how optimizing your formulation, tablet proportions, and tooling design ensures proper de-aeration for consistent quality.

Targeted Protein Degraders: Transforming Oral Therapeutics

CDMOs play a critical role in TPD development by offering specialized infrastructure and analytical capabilities to support the transition from preclinical research to clinical supply and commercialization.

SOLUTIONS

USP 661.1 Vs 661.2: Key Differences And Compliance

USP 661.1 and 661.2 introduce rigorous, risk-based standards for pharmaceutical plastic packaging, emphasizing material characterization, system suitability, and extractables/leachables testing.

Fine Chemical Manufacturing Services: R&D From Concept To Commercial

Our FCMS offers comprehensive research and development services and is equipped to handle all your product development needs, bringing your projects from concept to production.

Oral Solid Dose Manufacturing

We provide cGMP manufacturing services that scale with your development and approval milestones, ensuring a seamless transition from clinical to commercial supply.

Innovative Formulations And Higher Drug Loads Across The Life-Cycle

Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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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