High-Concentration, Low-Volume Subcutaneous Formulation

High-concentration biologics are forcing a reckoning across formulation, device design, and fill-finish, where a single threshold in viscosity or injection force can turn a promising molecule into a manufacturing nightmare. Join industry experts with direct experience in this area as they unpack the hidden thresholds, cross-disciplinary trade-offs, and what it really takes to get a high-concentration biologic from the bench into a patient's hands.

Register Free: https://www.pharmtech.com/pt_w/high-concentration

Event Overview:

High-concentration biologics are pushing the limits of what can be formulated, filled, and delivered as a low-volume subcutaneous injection, forcing tighter coordination across formulation science, device engineering, and CDMO fill-finish operations than ever before. As more pipeline candidates require concentrated, small-volume presentations to support at-home or self-administered dosing, professionals across this value chain are contending with viscosity, stability, and injectability constraints that can make or break a program's manufacturability.

This conversation brings together experts spanning formulation, device design, and fill-finish to unpack where these challenges actually bite, whether there are hard thresholds that change everything once crossed, and how decisions made early — often in a different discipline entirely — can quietly constrain what's possible downstream. Getting this right determines whether patients can self-administer a therapy at home instead of requiring an infusion visit, directly shaping treatment burden and access. As the industry leans further into high-concentration, low-volume formulations, understanding today's bottlenecks and where the field is headed over the next three to five years is essential for anyone working across CMC, device, and manufacturing functions.

Key Learning Objectives

• Identify the key technical hurdles in translating a high-concentration biologic from formulation bench to a viable subcutaneous injectable, including viscosity, stability, and delivery-device constraints.
• Recognize critical thresholds—concentration, viscosity, injection force, or fill-line parameters—beyond which downstream formulation, fill-finish, and device compatibility become significantly more difficult.
• Understand the market and clinical drivers that have accelerated demand for high-concentration, low-volume subcutaneous formulations over the past two to three years.
• Trace how upstream decisions made in other disciplines (e.g., molecule design, device selection, fill-finish strategy) can constrain formulation and manufacturing choices later in development.
• Anticipate where the field is heading, including emerging technologies, formulation strategies, and patient-centric delivery innovations expected to reshape high-concentration biologics manufacturing in the next three to five years.

Who Should Attend

This Drug Digest episode is best suited for professionals directly involved in formulation and development of large molecules, especially:

• Formulation scientists working on high-concentration biologics, protein stability, and viscosity-reduction strategies
• Drug delivery/device engineers designing autoinjectors, prefilled syringes, and other subcutaneous delivery systems
• CDMO fill-finish and manufacturing professionals managing high-viscosity fill-line challenges and scale-up
• CMC and process development leads overseeing the bench-to-clinic-to-commercial translation of biologics
• Analytical and characterization scientists working on viscosity, injectability, and stability testing
• Regulatory affairs professionals tracking device-combination and subcutaneous formulation submission requirements
• Program/product managers and R&D strategists making early-stage decisions that affect downstream manufacturability
• Patient-experience and human factors specialists focused on self-administration and at-home dosingsign unlocks speed, consistency, and compliance for continuous bioprocessing.
  

Speakers:

Flora Felsovalyi, PhD
Head of Pharmaceutical Services,
Lonza Integrated Biologics

Serves as Head of Pharmaceutical Services for Integrated Biologics at Lonza. She brings over 20 years of experience leading combination product development in the medical device and pharmaceutical industries, specializing in parenteral drug delivery. In this role, she leads a team responsible for developing and offering device-related services to customers, as well as non-GMP manufacturing of prefilled syringes.

Mary Evelyn Hudson
Director, Business Development,
Lifecore Biomedical

A business development leader in the pharmaceutical and biotechnology industry with extensive experience in CDMO solutions, strategic partnerships, and technical operations. Throughout her career, Mary Evelyn has held leadership roles spanning business development, validation, quality systems, and technical services at organizations including Woodstock Sterile Solutions, DPT Laboratories, Wockhardt, Mallinckrodt Pharmaceuticals, Bayer HealthCare, and Baxter Healthcare.

Ryan Swanson, PhD — Director, Process Development, Lifecore Biomedical
Through his current position at Lifecore and more than five years at Bristol-Myers Squibb, Ryan Swanson has more than 13 years of industry experience working on a wide range of projects (early- and late-stage, commercial, injectables, medical device, combination, topicals) for a variety of products (biologics, small molecule, polymers, peptides, hydrogels, suspensions/emulsions, ADC) across multiple subject areas (process development, GMP manufacturing, tech transfer, scale-up, analytical development, raw materials).

Uday Harle, PhD
CEO, Shilpa Biologicals Private Limited

A PhD in pharmaceutical sciences with 24 years of techno-commercial experience, the majority in biological development. Over 14 years, Dr. Harle served in leadership as Head at Abbott, assistant VP at Amneal Biologics USA, and Head at Ferring global R&D center, during which he enabled many BLAs/marketing authorizations with the FDA and filed many INDs for biosimilars and novel biologics. He has also led end-to-end development of many biologics, generics, and CAR-T therapies with large commercial global portfolios and successfully registered multi-million-dollar oncology and specialty products across the FDA, EMA, MHRA, Health Canada, ANVISA, and CDSCO.

Register Free: https://www.pharmtech.com/pt_w/high-concentration