Drug Delivery Experts
11494 Sorrento Valley Road, Suite J
San Diego, CA 92121
T: (888) 397-0107
E:
info@ddelabs.com
Website: www.ddelabs.com
LinkedIn: linkedin.com/company/ddelabs
Twitter: twitter.com/drugdeliveryexp

 

DRUG DELIVERY EXPERTS (DDE LABS) is your go-to partner for Contract Drug Product R&D, Simple Solution to Complex Liquid Formulations, and Clinical Trial Materials Manufacturing in a Sterile Suite.

We specialize in parenteral drug products from solutions to particulate systems and long-acting technologies. We are also experienced in oral, nasal, and ocular formulation development.

GMP FACILITIES: TRANSITION FROM FORMULATION TO CLINICAL TRIALS

DDE Labs now has GMP fill finish manufacturing for sterile drug products to serve our client needs. We offer compounding and filling capabilities from simple solution to gel-forming polymer, and micronized suspension. Our lab specializes in therapeutic modalities from small molecules to peptides, proteins, oligonucleotides, and antibodies.

The quality system is designed for aseptic manufacturing under GMP conditions of early phase clinical trial materials and toxicity test article. Vials are filled using disposable containers in a semi-automated operation in ISO 5 laminar flow hoods in an ISO 6 clean suite. GMP release testing is conducted in-house and stability testing is conducted for ICH conditions in 24/7 monitored chambers.

CUSTOM DESIGNED FORMULATIONS FOR TARGETED DELIVERY

DDE Labs can custom design a delivery system for your product by improving stability, bioavailability, solubility, and dosing frequency. We have experience in multiple routes of administration including parenteral (SC, IV, IM, intrathecal, intraarticular), oral, ophthalmic, nasal, topical, and inhalation products.

  • Develop methods for formulation, analytical, process, chemistry, and device
  • Peptide and small molecule chemistry, conjugation (e.g., PEGylation), salts
  • Lead candidate selection, optimizing pharmaceutical properties
  • Extended-release injectable delivery technology
  • R&D for novel and proprietary delivery technologies (ours and yours)

Our expertise ranges from preclinical formulation to clinical supply and commercial product reformulation with extensive experience in small molecules and biologics.

WE COLLABORATE WITH YOUR SCIENTISTS FOR THE BEST POSSIBLE PROJECT OUTCOME

  • Specialists in combination drug product development
  • Extensive industry experience in biologics drug development
  • Creative formulation solutions drawn from broad experience base
  • Highly-qualified Ph.D. scientists from pharma backgrounds
  • State-of-the-art R&D lab
  • We thrive while working on your most challenging formulations and processes

R&D SUPPORT FROM RESEARCH THROUGH COMMERCIAL PRODUCT LIFE CYCLE SUPPORT

Each of our experts has more than twenty years of experience in pharmaceutical research, development, and commercialization. Our experts work to customize a formulation or drug delivery solution that best meets your product profile.

Your drug product is our work product and we treat it as if it were one of our own.