Our Reputation is Built on Results
No matter how routine or complex the project, AAIPharma Services continually meets and exceeds customer expectations. You can turn to us whether you need to move a well-established project forward quickly and reliably, or to leverage the right expertise to meet difficult drug development challenges.
These case studies illustrate how we have helped our customers. If you would like to learn more about the capabilities described here or in another area in which you are seeking our assistance, please contact us. We are happy to share our insights and discuss how we can assist your organization.
Accelerated Formulation Development Meets NDA Submission Goal
Requiring a major change in a drug development approach, a pharmaceutical company asked AAIPharma Services to accelerate the timeline for developing an extended release dual active solid oral formulation. An array of excipients to achieve proper product stability and desired active release profile was under investigation. These activities generated a tremendous number of samples requiring testing. Rapid turnaround was critical for making formulation decisions and meeting the targeted clinical and submission dates.
Download a PDF of this case studyAnalytical Support Meets Aggressive Timeline for Product Development and Improves QC Testing
Requiring a major change in a drug development approach, a pharmaceutical company asked AAIPharma Services to accelerate the timeline for developing an extended release dual active solid oral formulation. An array of excipients to achieve proper product stability and desired active release profile was under investigation. These activities generated a tremendous number of samples requiring testing. Rapid turnaround was critical for making formulation decisions and meeting the targeted clinical and submission dates.
Download a PDF of this case studyAccelerated Transfer Speeds Manufacture of In-licensed Oncology Compound
AAIPharma Services was called upon to accelerate transfer of an in-licensed anti-cancer compound. The pharmaceutical company sought release to the U.S. and European Union of Phase II immediate release tablets within five months of the request for proposal.
Download a PDF of this case studyAdvanced Electronic Tongue Technology Quickens and Assures Good Taste Match
A taste-masking study was needed for a pharmaceutical company’s drug. The company wanted an oral powder for reconstitution as a suspension to provide a fast, aqueous dispersible vehicle. The result needed to be palatable and mask the drug taste while forming a pharmaceutically acceptable suspension when mixed with the drug.
Download a PDF of this case studyCollaboration Leads to World-Wide Disinfectant Qualification and Lifting of FDA Consent Decree
Facing a consent decree to qualify its disinfectants to FDA standards within the year, a pharmaceutical company contracted with AAIPharma Services to acquire the testing materials, develop and execute the protocols and cover each of its manufacturing sites within eight months.
Download a PDF of this case studyAccelerated Transfer moves Orphan Drug Product to Manufacture Faster
A pharmaceutical company purchased the rights to produce a medically necessary drug product at risk of becoming unavailable in the marketplace. However, the rights to this orphan drug stipulated the product could not be manufactured at its original site. The company requested an accelerated transfer plan for manufacture by AAIPharma Services, noting the urgency created by marginal inventories and limited existing API.
Download a PDF of this case studyMethod Developed Monitors Adjuvant Levels in a Vaccine and Satisfies FDA Requirements
AAIPharma Services was asked to develop a method to monitor levels of an adjuvant in a vaccine product. The adjuvant component was a high molecular weight polymeric compound with no UV chromophore. The polymer contained both strongly hydrophobic and strongly hydrophilic groups and was present in very low levels in the vaccine matrix. A robust and accurate analytical method that could address the challenges posed by the amphiphilic nature of the molecule and high ionic strength of the adjuvant matrix was needed to satisfy FDA requirements.
Download a PDF of this case studyImproved Wettability Readies Orally Administered Drug for Clinical Trials
A pharmaceutical company approached AAIPharma Services to manufacture three strengths of immediate release capsules for a blinded study. In this case, the company was using a drug with extremely poor solubility across the pH range and distinct processability and uniformity problems. The client needed to increase the solubility and wettability of the drug to achieve immediate release (NLT 75% at 60 minutes).
Download a PDF of this case studyOn-site Staffing for Analytical Testing Prevents Regulatory Sanctions and Product Market Disruption
Regulatory commitments and shifting product lines for a pharmaceutical company put product market supply at risk and presented a high probability of regulatory sanctions. The situation created a critical, accelerated demand for GMP-compliant analytical testing and the company turned to AAIPharma Services for on-site help.
Download a PDF of this case studyAnalytical Testing Laboratory meets Aggressive Timeline In Support of Manufacturing Process Validation
A pharmaceutical company came to AAIPharma Services needing a laboratory that could transfer an existing validated method and then test several hundred samples in support of manufacturing process validation studies. Meeting the imposed timeline was critical to ensure a manufacturing-related impurity was well controlled.
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