Dosage Form Development

Ascendia offers a range of final dosage form options for our client’s development projects. Our proprietary nanotechnologies allow us to develop enabling formulations for a variety of dosage forms for small molecules and biologics, including lipid nanoparticles that encapsulate and deliver gene therapy. Our expertise and technologies also allow us to transition the new dosage forms to expand the treatment options.

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Our Capabilities

Dosage Form Development Services

Ascendia has proprietary nanotechnologies that allow our scientists to develop formulations so drugs can be used in desired dosage forms. We can also advance projects due to our full-scale capabilities to manufacture cGMP clinical batches of various dosage forms for early and latestage clinical studies. All manufacturing operations are conducted in a qualified ISO 5 or ISO 7 cleanroom.

Oral Dosage Forms

Formulation & Manufacturing

Ascendia has the capability of spray drying, wet milling, liquid capsule filling, and homogenize for insoluble API; but also Ascendia can granulate, blend, roller compact, and compress to make tablet and capsule batches for immediate and modified release applications. We can use extrusion or fluid-bed coating - for controlled release products, as well as taste-masked the APIs in pediatric formulations.

Parenteral

Multiple Injectable Forms

Ascendia develops formulations and manufacturing capabilities for all parenteral routes, including subcutaneous, intramuscular, intravenous, intravitreal and intrathecal. Our - scientists are adept in the various injectable dosage forms – liquid solutions , nansuspension, suspensions, emulsions, liposome, lipid nanoparticles, polymeric microparticles and lyophilized dry powder.

Topical

Transdermal Services

Ascendia has the ability to formulate gel, creams and ointments for topical application to the skin or mucous membranes, as well as solution, suspension and nano-emulsions that are suitable for ophthalmic drop application to the eyes. We also manufacture solution and suspensions for use in inhalation and nasal spray in our cGMP facility.

Sterile Dosage Forms

Sterile dosage forms are pharmaceutical drug preparations that must be contamination-free because they bypass the body’s usual defenses against infection. The manufacture of sterile dosage forms is highly regulated and requires specialized equipment and protocols. Ascendia checks all those boxes.

Semi-Solid Dosage Forms

Semi-solid dosage forms are on the rise because these drugs are easy to administer and can be produced in a variety of formulations. Ascendia has the experience to overcome the challenges in developing and manufacturing semi-solid dosage forms.

Routes of Administration

Ascendia has the experience, technologies, and commitment to develop formulations to optimize the route of administration. We base all our development processes on whether the dosage form is oral, parenteral, topical, inhalation or others.

Your Drug Development Partner

Pre-formulation To Commercialization

Drug development teams select Ascendia as their CDMO partner because we can address the complex issues in various stages of dosage form development. More importantly, our technologies and expertise allow us to realize the dosage form that can be most effective at every development stage, creating the most efficient pipeline. The result? A drug with the most effective dosage form for formulation, manufacturing, and treatment.

Formulation

Optimizing Drug Development

The Ascendia scientific team begins with a pre-formulation and biopharmaceutical properties assessment. If a molecule is more advanced, Ascendia can utilize its formulation optimization services designed to provide a commercial dosage presentation.

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Manufacturing

State-of-the-art Facility

Ascendia manufactures cGMP clinical batches of sterile and non-sterile dosage forms for early-stage and late-stage clinical studies. Our state-of-the-art 60,000 square foot facility includes 17,000 square feet of cGMP manufacturing and warehouse that includes ISO-5,ISO 7, ISO 8 process and filling room space, to offer Phase 3 and commercial supply.

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Dosage Form Development