Element’s integrated global network is at the forefront of formulation, development, and sterile clinical manufacturing solutions for all routes of parenteral administration, including intravenous, subcutaneous, intramuscular and implantable dosage forms for both small and large molecules.

Our fully integrated, phase-appropriate solutions for parenteral drug product development and clinical manufacturing services have been built upon a strong foundation of deep scientific and regulatory expertise, highly skilled formulators, an industry-leading analytical team, and a resolute commitment to quality and compliance. Element’s parenteral formulation experts support both aqueous and non-aqueous formulations with a comprehensive suite of services built upon the principles of Quality by Design (QbD), resulting in enhanced performance and stability of a wide range of parenteral dosage forms and routes of administration in conjunction with streamlined scale-up activities.

Target Product Profile (TPP) support for small and large molecule parenteral formulations

The successful development of optimal parenteral formulations can be accelerated with the use of a thorough QbD approach which first begins with the development of a well-defined target product profile (TPP), also referred to as a quality target product profile (QTPP). Given the specific requirements for sterile products, need for administration devices, and range of potential end users, a TPP is especially critical for parenterals. Element’s consultative team of expert formulators will ensure a robust product as they provide guidance and insight regarding practical issues common to parenteral products throughout the process of defining a TPP and ideal drug product development strategy.

Industry-leading large molecule parenteral product development

Element’s fully integrated, phase-appropriate solutions support the entire parenteral product development lifecycle for a wide range of biological therapeutic modalities, including monoclonal antibodies (mAbs), peptides, proteins/enzymes, antibody-drug conjugates (ADCs), lentivirus/adeno-associated virus gene therapies, cell therapies, other biologics including novel formats, and beyond. Overcome the challenges that arise during parenteral dosage form development due to the complexity of biopharmaceuticals and the highly competitive large molecule landscape with our tailor-made solutions designed to meet the needs of your drug development program.

Small molecule parenteral product development expertise

To successfully develop small molecule parenteral formulations, several complex formulation challenges must be overcome stability and process, as well as tolerance limitations. Furthermore, a number of active pharmaceutical ingredients (APIs) are poorly soluble, requiring the use of sterile, dispersible dosage forms and other technologies to improve bioavailability. Our team of formulators have a proven track record of successfully developing optimized parenteral formulations with a wide range of APIs, including those with poor solubility and stability.

The Element advantage

Our highly knowledgeable, consultative scientists will serve as a true partner throughout the drug development life cycle, guiding you through the development of stable parenteral products, from developing a target product profile (TPP), formulation optimization, and beyond with comprehensive chemistry, manufacturing, and controls (CMC) support, process compatibility, scale-up, and life cycle management and extension services.

Our facilities and processes have been designed to safeguard the quality and safety of your product. Our goal is to help you bring safe, robust, stable, and effective injectable products that comply with ever-expanding regulatory requirements to market quickly and efficiently.

To learn more about our phase-appropriate parenteral product development and clinical manufacturing services and solutions, contact us today.

  • Formulatibility studies (chemical liability assessments, biophysical characterization, colloidal and confirmation stability, rheology and viscosity)
  • Submicron particle characterization
  • Early-stage biologics parenteral formulation development
  • Formulation robustness testing
  • Late-stage large molecule parenteral formulations
  • Biologic drug product analytics and QC (analytical method development and validation)
  • In-use stability and compatibility studies
  • Selection and qualification of container-closure systems (extractables and leachables studies)
  • Packaging and device characterization studies
  • Manufacturing of liquid and lyophilized drug product batches (non-GMP lab and cGMP clinical-scale)
  • Pre-clinical and clinical trial material manufacturing
  • Aseptic manufacturing and sterile fill-finish
  • Technology transfer
  • Large molecule life cycle management formulations
  • Parenteral biologic line extension formulations
  • Development of target product profile (TPP)
  • Pre-formulation
  • Solubility testing
  • Early-stage formulation
  • Late-stage formulation
  • Formulation robustness
  • Parenteral product line extension
  • Parenteral life-cycle management formulations
  • In-use stability and compatibility studies
  • Formulation compatibility testing
  • Stability (moist-heat sterilization/autoclavability and alternative sterilization methods)
  • Sterility testing
  •  Aseptic manufacturing and sterile fill-finish

Our team of over 9,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.