Pharmaceutical Drug Development
We are compassionate and committed to our mission of striving to the development of innovative drugs products with therapeutically beneficial formulations and its expedited approval to the market for its potential benefits that may be experienced by patients by meeting the unmet clinical needs. Our strategic approach to niche formulation technology utilizes leading science and advanced technology in a collaborative environment aimed at identification and optimization of potential solutions between multiple disciplines.
Our team is strongly committed to providing scientific solutions with proactive customer service to the customers addressing end-to-end solution from early stages of development through clinical phases to commercial. We provide a wide range of research and development services from preformulation, formulation development, analytical development and testing, and stability studies. Our R&D labs are well equipped with state-of-the-art instrumentation as well as special cytotoxic and potent handling capabilities. If you are in looking for a long history of successful partnerships built on built-in emotional intelligence and elegant service at measurable rate with seamless solutions “Plough Center for Sterile Drug Delivery Solutions” is the answer.
Our 60 plus years legacy is built up on relentless focus on client-focused performance, feedback, regular metrics reviews. We may not have our own products in the market but Plough center touches so many patients and communities around the country everyday through our compassionate culture and service helping scientific communities in helping for the expedite approval of life changing medicines to meet the unmet needs in clinic and by changing the paradigm of standard of care.
Preformulation screening is the key aspect in drug development studies as it will provide a firm understanding of the physicochemical characteristics of the drug substance early on and can help accelerate the formulation and drug product development process. UTHSC Plough Center team has years of experience and expertise in drug preformulation screening with a comprehensive understanding of commercial manufacturing processes to assist you in developing pharmaceutical sterile products from bench side to bedside.
Formulation Services
Until and unless a drug substance is transformed to a quality drug product in a specific dosage form to be effectively delivered to patients, no active molecule can reach the user successfully to elicit its therapeutic effect. This signifies the importance of formulation contribution in the success of a drug molecule. Plough Center team has the required expertise and experience to meet the needs of the patient, customer, and API and provide excellent scientific solutions needed.
Plough Center formulation development expertise, combined with a comprehensive understanding of commercial pharmaceutical manufacturing processes, can help you accelerate your product’s path from “lab scale to Rx” successfully. Our team has a wide and varied background of pharmaceutical development experience across an extensive range of compounds. Plough Center develops preclinical, early phase/late phase formulations for NCE drugs, OTC products, generic products, and orphan drug candidates.
Our capabilities include support for the following dosage forms:
- Solutions
- Suspensions
- Emulsions
- “Nano-Space”-Nanoparticles, Nanoemulsions, and Liposomes
- Lyophilized Products
- Generic and Innovative Products
- Cytotoxics
- Controlled substances
- Potent compounds
- Lyo cycle development
Formulation development equipment:
- DSC
- TGA
- Zetasizer
- Homogenizer
- Microfluidizer
- Extruder
- Probe Sonicator
- Lyophilizer
Whether it is in R&D or in commercial phase, until and unless a formulation or drug product is evaluated for its quality and stability by reliable and accurate analytical methods, no formulation can reach the market. This indicates the significance of analytical studies during the drug product development and manufacturing. We understand the importance of quality and our expert team of scientists at Plough Center has the required expertise and experience in providing reliable and accurate analytical services to clients to support the formulation research and development, and stability testing studies.
We support the clients in developing robust analytical methods and validation in all stages of drug development, from “lab scale to Rx”. Our analytical support services include:
- Analytical method development and validation
- Sterility testing
- Membrane filtration
- Direct inoculation
- R&D stability studies
- ICH stability testing
- Stability-indicating assay development
- In vitro release studies
- Method transfer through technical packages
- Residual solvent determination
- Moisture content analysis
- In-process testing
- Extractables and leachables
- USP particulate testing: HIAC
Analytical Equipment:
- Liquid Chromatography (HPLC) – DAD detector, Fluorescence Detector
- Ultra-Performance Liquid Chromatography (UPLC) – PDA detector, Mass-Spec detector (Single Quad)
- LC-MS/MS
- FTIR
- NMR
- UV-Vis and IR spectroscopy
- Karl Fisher Moisture Analysis (KF)
- pH Meter
- Stability Chambers
- USP Particulate Testing: HIAC
- Sartocheck 4 (Filter Integrity Testing)