Newsletter | December 17, 2025

12.17.25 -- How AI Is Rewriting Tech Transfer Timelines

INDUSTRY INSIGHTS

Taking An Alternative Approach To Drug Delivery

Novel therapeutics are driving demand for alternative drug delivery methods. Explore the latest approaches and understand the formulation challenges and benefits for specific diseases.

Development And Manufacture Of A Highly Potent OSD Product

Discover how a strategic CDMO can safely accelerate high-potency compounds with advanced containment, precise tech transfer, and solutions to complex manufacturing challenges.

5 Advancements In Tablet Compression That Pharma Can't Ignore In 2026

New materials, smart automation, and in-press quality control are optimizing tablet compression. These five key innovations are driving efficiency and consistency in solid dose manufacturing today.

FEATURED EDITORIAL

How AI Is Rewriting Tech Transfer Timelines

By replacing trial-and-error with virtual simulations and predictive analytics, AI is giving even small biotechs the process development capabilities once reserved for Big Pharma — and slashing tech transfer timelines in the process.

FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs

The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

INDUSTRY INSIGHTS CONTINUED

From Outsourced To In-House: Establishing On-Site Lab Services

Laboratory testing services for biopharmaceutical development often are outsourced, but insourcing offers sponsors greater control and stability by combining provider expertise with sponsor infrastructure.

Accelerated Development Of Solid Oral Dosage Formulation For IND Submission

This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

Nanoparticle Engineering: Revolutionizing Oral Drug Delivery

Nanoparticle engineering has emerged as a promising solution for enhancing drug solubility and bioavailability and improving efficiency within the drug development pipeline.

SOLUTIONS

Capabilities Update October 2025: Analytical Services

Consider this formulation development workflow for mAbs to provide a more efficient process, driving down costs and reducing timelines, without compromising on quality and hence patient safety.

Capabilities Update October 2025: Small Molecule

Choose an experienced CDMO specializing in high-potency softgels and liquids to ensure high-quality products, responsive service, and reliable solutions across complex therapeutic areas.

Analytical Services That Accelerate Drug Development, Commercialization

Our analytical services deliver rapid, precise method development using advanced chromatographic, spectroscopic, and mass-spectrometric solutions for diverse compounds.

Comprehensive CDMO Services From Clinical To Commercial Supply

From world-class facilities across North America and Asia, high-quality drug products are manufactured and supplied to over 100 global markets, supporting patient and healthcare needs.

Technology To Overcome Absorption Hurdles And Solubility Limitations

For poorly soluble drugs, overcoming absorption hurdles can hinder development. Explore a solution that empowers researchers to overcome solubility limitations and accelerate drug development.

High Potency Active Pharmaceutical Ingredients

Highly Potent APIs and cytotoxic compounds are crucial components in treating disease. Obtain specialized expertise for these materials to ensure safety and security.

Solid Form Services

Solid form selection considers chemical makeup and crystal structure, supported by efficient workflows that assess and choose optimal forms to meet each program’s needs.

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.

Connect With Outsourced Pharma: