Services

We’re in the business of collaborating with clients on their Sterile Injectable development programs. Our capabilities allow us to handle difficult formulation types and take those products to the appropriate stage of fill/finish.

Services / Capabilities at a Glance

  • Sterile filling

  • Formulation and process development

  • Lyo and sterile processing development

  • Product Types: High potent compounds, cytotoxics, vaccines, viscous products, Biologics, small molecule

  • Tox Lot Manufacturing

  • Project Management and Tech Transfers

Filling Services

In every development program, there comes a point where you need your sterile drug filled in a container. We’re setup with GLP filling capabilities to service phase-appropriate studies, providing the services industry needs without the overhead of a GMP fill/finish operation.

Formulation and Process Development

If your formulation and process is not ready for the manufacturing floor, we have the depth and experience to take a bench procedure and modify it for the next step.

Mixing, sterile filtration, temperature control, and filling parameters are just some of the key process parameters we evaluate when executing a development program.

Lyophilization and Sterilization Development

We design and optimize freeze-drying processes to enhance product stability and scalability. Our team supports formulation, cycle development, and scale-up to ensure robust and efficient lyophilization outcomes.

We develop and validate sterilization processes to ensure product safety and regulatory compliance. Our expertise spans aseptic design, method selection, and process optimization for both liquid and solid dosage forms.

Product Types

Beyond conventional small-molecule products, we’re equipped to handle challenging formulations that many CDMOs avoid. Our specialized equipment, facilities, and procedures enable safe, compliant processing of complex or sensitive materials.

Tox Lot Manufacturing

When it’s time to initiate your toxicology studies, we provide a comprehensive, turn-key solution. From formulated product through fill-finish, packaging, and shipment. Ensuring your material is ready for study without added complexity.

Project Management & Technical Transfers

Effective project management is as the heart of any successful endeavor in the pharmaceutical industry. Our project management practices are the game changer for our customers and we take pride in that.

The way we manage projects comes from a mix of traditional project management fundamentals, pharmaceutical industry best practices, and the lessons we’ve learned along the way. It all starts with a plan, which rolls into execution, and finishes with project closure activities. No matter the size or scope of the project, these three core activities are equally important and not one can be overlooked.

Every CDMO has their special niche. What every CDMO does not have is the ability to tech transfer programs in and out of their operation on behalf of a client. Elemental Pharma Services prides itself on our ability to bring tech transfer expertise to every program we touch.