Leveraging Quality by Design (QbD) for Advanced Pharmaceutical Development

Milan, Italy: –  Innovative CRO Delim Cosmetics & Pharma s.r.l., at the recent AFI Symposium in Rimini, showcased how the Quality by Design (QbD) approach is becoming a cornerstone of modern pharmaceutical development.

QbD is a science- and risk-based methodology that enables the design of robust and well-controlled manufacturing processes from the very beginning. Its primary goal is to embed quality into the product at every stage of development, moving beyond the traditional reliance on end-product testing.

By adopting QbD, companies gain deeper insight into their products and processes, enhance operational efficiency, shorten development timelines, and streamline regulatory approval. In an increasingly competitive landscape, QbD stands out as a strategic tool for developing both generic and innovative pharmaceutical products with high standards of quality, safety, and efficacy.

Real-world applications of QbD

At the 64th AFI Symposium, held in Rimini in mid-June 2025, Delim presented three scientific posters showcasing its in-depth expertise in advanced Quality by Design (QbD) methodologies. These approaches enable streamlined and cost-effective pharmaceutical development while fully complying with stringent regulatory requirements.

Each poster focused on a real-world case study involving the development of a generic semisolid product containing a non-steroidal anti-inflammatory drug (NSAID), where QbD principles were successfully applied to overcome formulation and manufacturing challenges—while ensuring full adherence to regulatory standards outlined in EMA guideline EMA/CHMP/QWP/708282/2018 REV.1 Specifically, the following posters were presented:

• Regulatory-compliant Q1/Q2/Q3 development of a generic semisolid topical product in accordance with EMA guideline (EMA/CHMP/QWP/708282/2018 REV.1) on quality and equivalence of locally applied, locally acting cutaneous products.
• Regulatory-compliant IVRT development for Q3 equivalence of a generic topical non-steroidal anti-inflammatory drug emulgel according to EMA guideline EMA/CHMP/QWP/708282/2018 REV.1.
• Pharmaceutical development of a generic topical emulgel using a Quality by Design approach.

The latter study – presented by researchers Federica Ronchi, Mattia Ghisolfi, Carola Gaffuri, and Celestino Ronchi—stood out for its methodological clarity and technical rigor. It received an official commendation from the AFI organizing committee, chaired by Dr. Giovanni Boccardi, in recognition of its scientific quality and meaningful contribution to the symposium’s focus on modern pharmaceutical innovation.

QbD – From Concept to Control

The emulgel project represented a textbook application of Quality by Design (QbD) principles across four key stages of the pharmaceutical development lifecycle:

• Defining the Quality Target Product Profile (QTPP): The project began with a clearly defined Target Product Profile (TPP), identifying the critical quality characteristics relevant to the intended clinical use. These included spreadability and texture, appropriate pH range, rheological parameters, in-vitro release performance (IVRT/IVPT), and both physical and chemical stability—ensuring alignment with EMA expectations for generic topical products.
• Risk Assessment and Identification of Critical Attributes: Through a structured risk assessment, Delim identified key Critical Quality Attributes (CQAs), such as drug content, viscosity, and release profile; Critical Material Attributes (CMAs), including polymer concentration and compatibility studies between API and each excipient; and Critical Process Parameters (CPPs), such as mixing time and homogenization speed.
•  Design of Experiments (DoE): Using a systematic Design of Experiments (DoE) approach, Delim investigated the impact of input variables on the CQAs. This enabled optimization of the formulation composition, identification of variable interactions, and establishment of a statistically driven design space. This design space formed the basis for a robust control strategy, including in-process controls for real-time adjustments (e.g., pH), release specifications to ensure batch-to-batch consistency, and long-term stability monitoring under ICH conditions—all aimed at minimizing variability and ensuring reproducibility at commercial scale.

Broad QbD Strategy

The emulgel and other projects presented at the 64th AFI Conference in Rimini served as compelling demonstrations of how QbD is not just a theoretical framework but a practical, value-driving discipline when expertly applied.

The AFI committee’s recognition of poster work reflects Delim’s role as a leader in embedding QbD into topical and dermal product development as part of its broader strategy to offer QbD-driven development across a wide portfolio, including semi-solids and transdermal systems, oral delivery systems, ophthalmic and injectable drugs, inhalables, and niche delivery systems.

Delim continues to invest in QbD as a cornerstone of its service offering delivering products that are regulator-ready, commercially viable, and scientifically robust — from development through to scale-up and market launch.

For clients, Delim’s QbD capabilities translate into:

• Accelerated development timelines through predictive modeling and DoE
• Cost reduction by minimizing rework, failed batches, and unnecessary studies
• Streamlined regulatory interactions, thanks to data-rich, risk-mitigated dossiers
• Robust, reproducible product quality, built into every batch

About Delim

Headquartered in Vimodrone, Milan, Delim Cosmetics & Pharma s.r.l. is a dynamic and innovative Contract Research Organisation (CRO) specializing in the development of both innovative and generic pharmaceutical formulations.

The company excels in the design, patenting, and technology transfer of pharmaceutical products, providing advanced B2B services to companies seeking cutting-edge technical and scientific support for drug development.

Delim’s comprehensive service portfolio covers the entire pharmaceutical product lifecycle, including patent assistance and sourcing of active pharmaceutical ingredients (APIs), prototype development, and clinical trial support; scale-up of manufacturing processes and technology transfer to GMP-compliant facilities; production of pilot, validation, and bio batches; regulatory consulting and dossier preparation for drug registration.

The company possesses specialized expertise in developing semi-solid formulations (innovative and generic, Q1, Q2, Q3), solid oral dosage forms for immediate and controlled release using technologies such as fluid bed coating and spray drying. It also offers in vitro testing services for topical and ophthalmic products, alongside analytical method development and validation.

Delim’s extensive technology portfolio spans multiple therapeutic areas and delivery systems, including dermatology, gynecology, pulmonology, oncology, and ophthalmology. Additionally, the company specializes in formulations for medical devices aimed at applications in orthopedics and aesthetic medicine.

To learn more, visit: https://www.delim.it/

About AFI Simposio Rimini

The annual symposium hosted by Italy’s Associazione Farmaceutici dell’Industria (Pharmaceutical Industry Association) is dedicated to promoting knowledge exchange between science researchers and pharma companies.

The 64^th Edition Simposio AFI 2025 was again a three-day event, opening June 11 at the Palacongressi in Rimini, on Italy’s Adriatic coast.

Broad themes for the 2025 Symposium included ‘Energy and Sustainability’ exploring pharmaceutical world challenges and opportunities, ‘Innovation: From 4.0 to 5.0’ providing guidelines and practical examples, and ‘Clinical Research: Digitalization, Decentralization, Real World Evidence’ looking at new ways to make Italy and Europe more competitive.

The co-located Exhibition featured more than 140 participating companies and organizations.

The event is organized by the Italian Pharmaceutical Industry Association (AFI) with further details available at: https://simposio.afiscientifica.it/