Highly Potent API Handling
Pii operates over 360,000 square feet of state-of-the-art pharmaceutical development and manufacturing space, all located on one campus in Hunt Valley, MD. This includes over 70 flexible, manufacturing suites, several with the required containment controls for handling potent compounds and hormones, as well as a dedicated suite for the production of soft gel capsules. Licensed to manufacture DEA Schedule I-V products, with capabilities for both oral delivery and parenteral dosage forms, Pii has the depth to support development, clinical and commercial requirements. Facilities are cGMP qualified and include dedicated formulation development centers for solid oral, liquid and sterile products.
Potent Compounds
Pii has separate manufacturing suites with dedicated air handling systems to accommodate potent compounds.
Pii has the capacity to implement specialized containment technologies that enable us to help you with your potent compound.
DEA Schedule I-V
Pii is registered with the DEA (Schedules I-V).
Pii handles paperwork and quotas for your product.
Pii has DEA compliant cages and storage vaults with customizable temperatures to meet your product requirements.
Hormones
Pii has separate manufacturing suites with dedicated air handling systems to accommodate hormone compounds.
Pii has the capacity to implement specialized containment technologies that enable us to help you with your hormone compound.
Bioavailability Enhancement
Pii can help you with your bioavailability challenges of enhancing absorption of your BCS II, III and IV compounds.
Specialized dosage forms we can produce to help meet the challenges of bioavailability are:
- Amorphous formulations
- Complex solubilized systems
- Nano dispersions
First-in-Man Phase I
Pii can accelerate your path to clinic. We understand a company's need to do more with less. Whether your constraint is time, budget, or limited supply of API, Pii will design a development program customized to meet your goals. Early phase services include:
- Screening different solid forms
- Characterizing and selecting the best candidates for development
- Developing early phase fit-for-purpose formulations
- Manufacturing cGMP clinical materials
- Providing analytical services, methods development, validation and stability programs
Pii can take your API from pre-formulation to clinical supply release in an accelerated timeframe and we offer a variety of strategies to expedite product development for first-in-man studies.
A major barrier to the advancement of many NCEs is their poor solubility. To address these difficult to formulate compounds, Pii offers a comprehensive portfolio of drug delivery solutions.