Case Studies That Accelerate Scientific Innovation
Every successful therapy begins with solving complex scientific challenges. At Synergy Bioscience, we partner with pharmaceutical, biotechnology, and medical device companies to accelerate development through high-quality analytical testing, research, and scientific expertise. Our case studies highlight how we’ve helped clients overcome technical obstacles, meet regulatory requirements, reduce development timelines, and advance products from early research through clinical readiness. Explore these real-world success stories to see how our collaborative approach, rapid turnaround times, and commitment to scientific excellence help bring innovative therapies closer to patients.
In Pursuit of Excellence: Recent Extractable/Leachable Study Reaffirms Our Commitment to Pharmaceutical Safety
Synergy Bioscience, a Contract Research Organization specializing in product development, analytical chemistry, microbiology testing, and quality system compliance consulting services, recently completed an important project that highlights our core expertise. We designed and executed an Extractables and Leachables (E&L) Study for medical-grade storage bags used to hold Active Pharmaceutical Ingredients (API) Concentrate. This study underscores our unwavering commitment to pharmaceutical safety… Continue >
The Development of an Inhalation Drug Product
This case study highlights one of our recent ventures into developing a generic inhalation combination product, combining the capabilities of an inhaler with an inhalation spray, designed to enhance patient treatment experiences. Our journey began with the careful formulation of the product. Our expert team meticulously optimized the formulation to maximize its therapeutic potential. We conducted rigorous analytical testing, focusing on assay content and identifying potential degradants and impurities, ensuring the highest quality standards were met… Continue >
Fostering Innovation in Antibacterial Therapies: A Synergy Bioscience Case Study on the Development of a Generic Drug Product
At Synergy Bioscience, we specialize in transforming complex pharmaceutical challenges into remarkable achievements. In this case study, we highlight our collaboration with a client focused on developing a generic drug aimed at treating a broad range of bacterial infections, including those related to skin and gynecological health. Our journey began with a focus on enhancing the technological process, improving production efficiency, and increasing overall yield. Our team worked to perfect the preparation method for a critical beta-lactam inhibitor… Continue >
Synergy Bioscience and the Art of Overcoming Challenges: A Case Study in Aminoglycoside Antibiotic Development
Welcome to an exploration of Synergy Bioscience’s pharmaceutical expertise. This case study highlights our role in developing an advanced aminoglycoside antibiotic designed to treat severe bacterial infections. Our journey showcases how we combined scientific acumen with innovative techniques to overcome significant challenges, bringing a powerful antibacterial solution to life… Continue >
Unveiling the Potential of Innovative Drug Development with Synergy Bioscience: A Case Study in Peptic and Duodenal Ulcer Treatment
Synergy Bioscience prides itself on bolstering scientific advancement within the pharmaceutical industry. One of our most recent achievement showcases our ability to accelerate drug product development, surpassing technical hurdles to drive our client’s success. Here’s a journey into our collaborative efforts in bringing an innovative solution for peptic and duodenal ulcer treatment to the forefront… Continue >
Batch Record Reviews
After receiving an FDA Warning Letter, a well-known pharmaceutical company requested from Synergy to get involved in the remediation of their warning letter. Part of the warning letter remediation efforts was related to several thousands of product manufacturing Batch Records reviews. We started the work by verifying the calibration records, NCRs/Deviations, OOS investigations, and the in-process data… Continue >
Chemistry Lab Operation
A CRO/CMO pharmaceutical start up requested from Synergy to help with the set up and initial operation of their chemistry laboratory to support in the development and manufacturing of generic drug products. We started our collaboration effort by commissioning and qualifying the needed analytical instruments (HPLC, GC, TOC, etc.) and their related LIM System Software (Agilent OpenLab Software) as well as providing training and mentoring to the technical staff… Continue >
Cleaning Validation
As part of their cGMP facility operation readiness, a client of ours requested that we develop and validate a cleaning validation program to support their development and manufacturing activities of drug products that are in their late development stages. Using the Design of Experiment (DOE), we started by developing a master validation plan for sterilized processes (aseptic processing)… Continue >
Bio Process Validation
A biopharmaceutical company requested from Synergy to work with their engineering department and help in the optimization and revalidation of their manufacturing process of a therapeutic protein drug product. To integrate the upstream process with the downstream one, we did a re-validation of the downstream process of a monoclonal antibody and performed chromatographic HPLC analysis for samples from different phases such as biomass product separation, product purification, concentration, crystallization, drying and fill-finish among other activities… Continue >
cGMP Facility Transfer
A medical device company, developer and manufacturer of implantable class III medical devices, hired us to help in one of their cGMP facilities transfer. The project scope included the transfer of the manufacturing equipment and their related processes such as real-time control/manufacturing automation systems. Our team started the qualification process of newly designed ISO Class 7 cleanroom suite… Continue >
Supplier Quality Audit
A well-known biotechnology company requested from Synergy to review and improve their Supplier Quality Management system. The review process led to recommendations for the need to implement significant number of improvements and the need to revalidate their Supplier Quality software (Master Control). Then, we were asked to develop and execute a plan to perform audits to their large and diversified network of suppliers… Continue >
CAPA Process
A well known medical devices company was under Consent Decree and in desperate need of special expertise to help them get out of it sooner so they can resume their business. So, they contacted Synergy and we dispatched 22 of our consultants to expedite their remediation effort. Several of their business processes had compliance issues and we were asked to start with the Corrective Action/Preventive Action (CAPA) process... Continue >
From Sub-50% Purity to One Million Vials per Month - How Synergy Bioscience Helped a Client Scale a Peptide R&D Business from the Ground Up
A client came to Synergy Bioscience with a clear vision but a significant technical hurdle. They had identified a peptide material available from a foreign supplier at a competitive price point, and they intended to sell the finished product for research and development (R&D) purposes. However, the raw material they were able to source arrived at a purity level of less than 50%, far below the quality standard required for a reliable, market-ready R&D product… Continue >
How Synergy Bioscience Helped Advance a Novel Cancer Therapy to Phase 3 Readiness
A biotechnology startup developing an innovative biodegradable polymer-based combination product partnered with Synergy Bioscience to overcome the technical and manufacturing challenges required for clinical development. The product was designed to deliver a small-molecule therapeutic directly to a tumor-bearing organ. As the polymer gradually biodegrades, the drug is released locally, with the goal of reducing the need for systemic treatments such as chemotherapy and radiation. Although the client had a promising technology, they lacked the infrastructure needed to manufacture clinical trial material… Continue >