Services

1. Pharmaceutical Contract Manufacturing And Packaging: Creams, Lotions And Gels 5/22/2012

   Aphena Health & Beauty has the ability to blend a wide range of viscosities from aqueous based to crèmes, lotions, liquids, gels and powders. 

2. ADMET-PK and Bioanalytical Services 3/30/2009
   The ADMET-PK Team at SCYNEXIS understands the challenges in optimizing the bioavailability of a molecule and is well-equipped to determine compound adsorption, distribution and metabolism with state-of-the-art instrumentation and techniques. They are fully-integrated in our efforts to provide fast and efficient medicinal chemistry decision support for rapid hit seeking, H2L, lead optimization and candidate selection. Lead optimization projects are guided by a portfolio of in vitro DMPK assays including plasma stability studies, cytochrome P450 inhibition assays and metabolite identification leading to in vivo animal studies to determine PK parameters. We offer fully-integrated contract research, discovery and development services including Drug Discovery, ADMET-PK, Bioanalysis and Process Chemistry & GMP API manufacturing.

   Success with SCYNEXIS
   Our team works in state-of-the-art facilities with access to a comprehensive suite of high-end biological assays and bioanalytical instrumentation. We have successfully developed and delivered numerous assays to our clients’ drug discovery and development programs including:

   • CNS/brain tissue exposure for Stage II Human African Trypanosomiasis (HAT)
   • Ocular tissue distribution of novel drug candidates for dry eye indications
   • Prodrug and parent monitoring to improve bioavailability and release profiles

   In Vitro ADMET Capabilities

   Rodent & Large Animal PK Allometry Routes of Elimination	Tissue/CNS Distribution PK-PD Metabolite Profiling

   Bioanalytical Capabilities

   Method Development Sample Preparation Tissue Extractions Microtiter and Online SPE Metabolite ID Liquid Handlers

   PK Screening Tandem-MS (MRM and SRM) Triple-Quadrupole MS HTS Platforms (Beckman, Tecan, LEAP) Prodrug Studies PD Studies

3. Pharmaceutical Development 4/24/2023

   Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

4. cGMP Aseptic Manufacturing And Sterile Fill-Finish 1/28/2022

   Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.

5. Formulations For Poorly Soluble And Low Bioavailability Drugs 1/28/2022

   Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.

6. Autoinjector For Deep Intramuscular Delivery 2/10/2021

   Intramuscular
   0.5 - 3 ml

   ArQ^® - Vita can achieve large volume, deep intramuscular delivery, making it the ideal platform to deliver medication for chronic conditions. Built around Oval’s polymeric primary drug container technology, we can create a device that is small and simple to use, whilst housing the correct length needle to achieve consistent intramuscular delivery for your patient population.

7. Small, Simple-To-Use Package For Delivering High-Viscosity Formulations 2/10/2021

   Subcutaneous

   Low - Medium Viscosities
   < 100 cP
   1 - 10 ml

   High - Ultra-High Viscosities
   >100 - 10,000 cP
   0.5 - 3 ml

   ArQ^® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in  less than 5 seconds. The ArQ-Bios  platform  also can deliver  greater volumes than 1 ml subject to matching  the formulation characteristics with acceptable patient tolerability.

8. Patient-Centric Drug Delivery Device 2/10/2021

   ArQ is built around our primary cyclic olefin copolymer (COC) drug container. It offers an autoinjector that is simple to use, with the flexibility and ability to deliver a wide range of viscosities and volumes.

9. Clinical Manufacturing In Viral Vaccines 4/14/2014

   Charles River offers more than 20 years of experience in manufacturing viral vaccines.

10. Fill & Finish / Late-Phase And Commercial Pharmaceutical Manufacturing 1/28/2014

    OsoBio is committed to serving as your contract manufacturing organization (CMO) of choice for late-phase clinical trials and bringing them to commercialization – especially those that involve biologic, highly potent or controlled compounds.