Clinical Manufacturing

Once we align on deliverables, timelines and budget, our teams execute with focus and determination, delivering your clinical supplies on time with high quality.
Clinical Manufacturing

Clinical manufacturing, done right

Navigate crucial phases of your program with confidence by tapping into our dynamic capacity, innovative technology, and collaborative expertise. We produce clinical supplies with speed and precision spanning numerous dosage forms, where right first time is standard and commitments to timelines and quality are top priorities.

Supporting a wide range of dosage forms & routes of administration

Our clinical supplies manufacturing services ensure high quality and on-time delivery integrated with packaging, labeling, and kitting services. Powered by equipment and facilities designed to meet international quality standards, we provide flexible batch sizes to scale with your project. Our team is seasoned in solving complex challenges and is ready to support your project’s specific requirements.

Solutions and Suspensions

Leverage our depth of experience and breadth of capabilities across various delivery routes, including oral, intravenous, intramuscular, and subcutaneous, to accelerate your drug development program.

Solids and Semi-Solids

Our experienced team is well-equipped to meet your manufacturing requirements, including controlled substances, potent compounds, light-sensitive compounds, targeted release, and organic solvent processing.

  • Capsules: powder fill, API-in-capsules, pellets, liquid fill, and over-encapsulation
  • Tablets: monolayer, bilayer, mini-tablets, ODT, chewable, and sublingual
  • Semi-solids: gels, creams, and ointments

Topical and Transdermal

Topical dosage forms target sites in at least one skin layer, gland, follicle, or underlying tissue, while transdermal dosage forms target systemic circulation and avoid first pass metabolism in the gut wall and liver. With so many components to consider, formulation development for these routes of administration presents challenges unique to the skin or mucosal membranes.

Despite these hurdles, our team has robust first-hand experience developing gel, cream, lotion, and ointment semi-solid formulations. No matter where you are in your drug development process, we’ll be here to advance your preclinical or clinical studies.

Oral

Achieve a well-balanced dosage form with our team’s experience spanning both established and specialized processes. From preformulation to stability storage, we apply advanced technologies to improve solubility and bioavailability, even as your program scales across clinical phases. Trust our team to prepare, package, and test your oral clinical trial materials.

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Injectable

Trust our team to satisfy your injectable supply needs when manufacturing for clinical phases. By offering comprehensive services, including formulation and process development, our expertise in ophthalmic drug delivery paired with our specialized equipment positions us to be your ideal partner.

Ophthalmic

Establish your optimal ophthalmic formulation by identifying the best-suited delivery method and creating a well-balanced dosage form with our team. Whether your drug takes form as a solution, suspension, ointment, or emulsion, our experts are ready to help you take your program to clinical phases through commercialization. Our team keeps scalability in mind while ensuring sterility and microbe-resistance every step of the way.

Inhalation and Nasal

We provide integrated services starting with formulation and process development to support diverse drug products delivered through inhalation, nasal, and nebulization routes of administration. Our expertise in lyophilization, micronization, and particle-sizing technologies offers a diverse set of options for these routes of delivery. Our team then transfers the supporting processes to manufacture clinical supplies at one of our dedicated GMP facilities.

CLINICAL MANUFACTURING TECHNOLOGIES

  • Sterile Fill-Finish
  • Oral and Topical Drug Products
  • Packaging and Labeling
  • Bioavailability Enhancement

Sterile Fill-Finish

The demand for sterile fill-finish manufacturing continues to grow, especially for biologics and gene therapies delivered through parenteral administration. Our Sterile Fill-Finish Center of Excellence is GLP and GMP compliant, DEA-registered, and EU Annex 1 compliant.

Oral and Topical Drug Products

From tablets, capsules, multiparticulates, and powders to solutions, suspensions, and semi-solids, our quality-driven oral and topical drug product manufacturing supports your project from start to finish. Our experienced teams are equipped to manage demanding program requirements, including potent and controlled substances, light-sensitive compounds, targeted release profiles, and organic solvent processing.

Packaging and Labeling

Our trusted clinical packaging, labeling, and kitting services combine a range of advanced technologies and manual capabilities. We support both domestic and international distribution studies, backed by deep experience in diverse regulatory pathways and a rigorous approach to facility compliance.

  • Primary and secondary packaging: single- or multi-dose bottles and vials, tubes/applicators/jars, sachets, blister packs, pouches, sterile vials, prefilled syringes or bags, and dropper bottles
  • Labeling: randomized/open labeled, blind/non-blinded, over labeled, English or multi-lingual, and booklet labels
  • Kitting: standard kits, custom kit design, clinical trial patient kits, diagnostic kits, and ancillary item inclusion

Bioavailability Enhancement

By embedding bioavailability testing and enhancement strategies within the broader development plan, we help ensure that gains in exposure translate into stable, scalable, and clinically viable drug products. The goal is insight without excess and delivering meaningful results while conserving time, costs, and material.

Keeping drug development moving forward

Through materials characterization, formulation and process development, and bioavailability enhancement, our teams remove uncertainty early and help prevent downstream delays. We turn your demanding science into momentum with focused, material-sparing strategies that keep programs on track.

On demand resources

Formulation Strategies for Early Clinical Phase Studies

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Developing liquid formulations for the oral dosing of lipophilic drugs

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Understanding Polymorphism to De-Risk Drug Development

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Get in touch

Whether you’re shaping early plans or preparing to scale, our teams are here to help you move forward with clarity and confidence. Start the conversation and we’ll get back to you quickly.