Newsletter | March 10, 2026

03.10.26 -- A Biotech Business Model That's Investor-Friendly

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Regulators are shifting the biosimilar approval paradigm — prioritizing deep process understanding over large clinical trials. In this evolving landscape, defining and controlling CPPs is essential to demonstrating high similarity. Join Bioprocess Online’s Jon O’Connell on March 24th at 11 am Eastern for a live Q&A with Sarfaraz Niazi, Ph.D., Vince Narbut, and Diana Colleluori, Ph.D., as they explore how QbD and CQA insight can streamline development and regulatory success.. Register for free today thanks to support from sponsor Cytiva.

FOCUS ON OUTSOURCING

A Biotech Business Model That's Investor-Friendly

For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

Scaling Manufacturing Flexibility For Fill-Finish Commercial Success

Pharma and biotech developers rely on adaptable fill‑finish capacity to meet evolving market demands, scale products from clinical to commercial, and respond rapidly to public‑health emergencies.

From Fed-Batch To Continuous: How Perfusion Enables Smarter Production

Growing biologics demand is driving interest in perfusion culture as a complementary manufacturing strategy that enables nutrient control and higher productivity when paired with fed-batch processes.

How CDMOs Adapt: Differentiators, Competencies, Prioritizing Quality

Modern drug manufacturing requires a shift toward partnerships that prioritize agility and quality. Success depends on specialized expertise and technical collaboration to navigate complex requirements.

The Gateway Delivery To The Brain

Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.

Shaping The Future Of Biologics Manufacturing

CEO Kenneth Bilenberg discusses building a CDMO's success on trust, reliability, and true partnership. The path focuses on agility to support biologics growth and the reshoring of U.S. manufacturing.

Overcome Common Pre-Filled Syringe Challenges Through Partnership

The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled.

A Strategic Enabler For Scaling Gene Therapies

Platform-based manufacturing uses standardized, pre-qualified workflows and analytics that reduce variability, simplify regulatory submissions, and accelerate the path to commercial success.

Demonstrating Value Throughout The Product Development Lifecycle

Examine how a partner with extensive capabilities and expertise adds value to drug development and helps to solve complex formulation, analytical, and manufacturing challenges our clients face.

Cis-Targeted Immunotherapies Need Large CDMO Expertise And Flexibility

Asher Biotherapeutics was seeking a CDMO that could handle Phase 2 through to commercial production, as well as taking early-stage projects in its pipeline all the way through their lifecycle.

ICP-MS And ICP-OES: Tools For Elemental Impurity Analysis

Leverage advanced elemental impurity testing methods to ensure the safety, compliance, and accuracy of your drug products throughout the manufacturing process.

OUTSOURCING SOLUTIONS

Enhance Your Formulation With Our Capabilities - Simtra BioPharma Solutions

A Line To Support Your Biologics - FUJIFILM Biotechnologies

GMP Manufacturing, Testing, And Development Services - Minaris

Comprehensive Manufacturing Solutions Backed By Global Expertise - Novartis Contract Manufacturing

Pioneer Solutions That Turn Hope Into Reality - Andelyn Biosciences

Advancing Sustainable, Animal‑Free Cell Nutrition - Nu-Tek Biosciences

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