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FORMULATION DEVELOPMENT

From Initial Formulation to Clinical Trials & Specialized Manufacturing

DDA, in partnership with industry leaders, offers comprehensive drug product development services covering the entire process from initial formulation to the production of the registration file ready for submission. Our drug product development begins with screening suitable formulations and processes to meet the defined target product profile. These formulations and processes are optimized to ensure robust and efficient manufacturing according to Design of Experiments (DOE) concepts.

 

Key Focus Areas:

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Solid Dosage Forms:

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  • Lab-Scale to Commercial-Scale Production: Starting with lab-scale batches, we scale up to pilot-scale and commercial-scale batch sizes as required.

  • Dedicated Facilities for Highly Potent Compounds: For highly potent oncological (both non-cytotoxic and cytotoxic) drug compounds, development activities are conducted in dedicated areas suitable for handling OEB4 and OEB5 compounds using PPE.

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Manufacturing Capabilities:

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  • Oral Solid Dosage Forms: Separate cGMP-compliant areas for non-potent and highly potent drug compounds. We offer bulk manufacturing from 1-50 kgs for clinical phase I-III studies.

  • Sterile Forms: Expertise in producing sterile solutions, lyophilized products, and emulsions.

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Specialized Areas:

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  • Penicillin and Cephalosporin Facilities: Dedicated areas for manufacturing oral solid dosage forms.

  • Hormones, Cytostatics, and ß-Lactams: Facilities equipped for handling these substances, ensuring safe and compliant manufacturing processes.

  • Clinical Trial Preparations: Sourcing and blinding of comparators, clinical trial packaging, and handling highly potent compounds.

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Partnered Expertise:

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DDA's partnered capabilities include:

  • Sterile Emulsions and Solutions

  • Lyophilized Oncology Products

  • Pre-Filled Syringes

  • Formulation Development for Oncological Solid and Parenteral Forms (up to OEB 5)

  • ß-Lactams in Solid and Sterile Powder Forms

  • Hormones and Hormone Blockers (up to OEB 4/5)

  • Organic Solvent Granulation for Highly Potent Compounds

  • Clinical Trial Medication

  • Modified Release Tablets and Two-Layer Tablets

  • Capsule Filling with Different Components

  • Stick Packs

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DDA's drug product development services ensure robust, efficient, and compliant manufacturing processes tailored to meet your specific needs, from preclinical development to commercial manufacturing.

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