Preclinical & Toxicology Formulation Development

 

QS Pharma can identify the means to dose a compound to a preclinical animal species.  The identified formulation results in the desired biologic exposure, presents the compound in a surrogate for an ultimate commercial formulation and produces no untoward effects due to the excipients in the formulation.  The formulations are identified for individual compounds for discreet studies or in complex mixtures for combinatorial pharmacokinetics studies.  Analytical concentration verification and stability evaluation can be performed for GLP studies.

Analytical Services

QS Pharma's analytical services range from Active Pharmaceutical Ingredient (API), Drug Product, Excipients and Packaging Components, Concentration Verification for GLP Toxicology Studies to Cleaning Verification. These services include Analytical Methods Development /Validation to support preformulation, in-process testing, finished product and stability programs. Stability Testing following ICH guidelines, Dissolution Testing, Development of Cleaning Methods. Active Pharmaceutical Ingredient Characterization, Physical and Chemical Characterization can be carried out prior to formulation development.

Phase I Development

QS Pharma will develop a formulation tailored to the properties of the molecule that will maximize the likelihood of your success in Phase I.  The development process which has been optimized by our cofounders can be tailored for your needs. QS Pharma can take you from discovery to First-in-Man study with minimum quantity of drug substance and an accelerated timeline.

Stability Evaluation

QS Pharma has the capabilities to perform stability testing of drug substance and drug product.

The storage chambers conform to the International Conference on Harmonization (ICH) requirements.  In addition, we also provide protocol development and special stability testing based on client, compound or regulatory requirements.

Product Development

QS Pharma can develop a stable, bioavailable and manufacturable drug product to meet your clinical and/or commercial requirements.  We will work closely with you during the development process to best satisfy your requirements.

The process includes:

• Formulation screening
• Drug product analytical method development
• Manufacturing process optimization
• Scale up
• Drug product stability

Clinical Supply and Submission Batch Manufacture

QS Pharma can manufacture your drug product and/or placebo for use in clinical trials.  Our state-of-the-art cGMP manufacturing facility will meet all your clinical supply manufacturing needs.

We can also make drug product batches for your world wide submission needs.

Comparator Blinding

QS Pharma will help you in developing a blinded formulation for your blinded positive-control clinical trials.  The blinding is accomplished by over-encapsulation, over-coating or grinding with reformulation of the comparator.  A placebo is manufactured to match the blinded comparator.  We will also manufacture the clinical supplies for your trials.

CMC Consulting

QS Pharma can provide strategies for drug product development and/or specific CMC related issues.  You can depend on our vast experience and varied background.

Analytical Services

QS Pharma provides screening of the critical physical and chemical properties of NCEs in the predevelopment phase.  The process determines the probability of technical success of developing the NCE into a commercial formulation.  QS Pharma will assist in the selection of the optimal salt and physical form, that will enhance the probability of success for further development.

 

 

Preformulation

QQS Pharma has the capability to provide you complete preformulation characterization of your molecule.

• development of analytical methods
• physical morphology
• particle size
• surface area determination
• thermal analysis
• solubility studies
• partition behavior
• solution stability
• solid state stability alone and in combination with excipients