Case Studies
- Enabling Formulation
- Labeling Process
- Supply Chain
- Urgent Fulfillment
Develop Enabling Formulation for Animal Health Client Case Study August 2016
Develop Enabling Formulation for Animal Health Client A top ten animal health company whose products target and treat some of the most harmful animal diseases. This client develops health products across the board from companion animal to food animal treatments and drug therapies. Singota Solutions has been working with this client for over four years in service areas that include supply chain, production, development, and analytical testing. Problem The client was in early stage development for a drug product to be used to treat a condition commonly seen in a large food animal. This condition causes several problems for these animals and their producers including increased waste, decreased production, extra labor, and costs associated with these issues. The client is evaluating a new administration form of the drug product to treat this condition. To begin they only had an API and no existing formulations. The client came to Singota to develop and evaluate possible formulations, and to optimize the formulations for several factors including viscosity, density, freezing point depression, drug delivery, and pH, while keeping in mind and avoiding possible manufacturing hurdles. Solution Singota was able to suggest a range of possible excipients that would create unique formulations to meet the client needs, and working together with the client Singota was able to develop over forty formulations. In only four months, Singota was able to formulate and analyze all forty formulations which were subsequently used in in-vitro studies for further characterization. Using all of the combined data, Singota worked with the client to determine three formulations that were optimized in all of the identified factors such as viscosity, freezing point, delivery, etc. Singota has also helped the client move forward in the development process by producing several small aseptic batches of the formulations to be used in pharmacokinetic studies, accelerated stability, and small clinical studies. Impact Singota was able to move quickly and help move the client from no formulation to having multiple lead formulations in a very short amount of time. Due to this work, the client will be able to continue clinical studies and determine the feasibility of moving this product forward along the drug development pathway. Singota continues to support this project with ongoing stability testing as well as producing material for ongoing in-vivo testing.
Innovating Labeling Process for Animal Health TAS Study Case Study August 2016
Innovating Labeling Process for Animal Health TAS Study A top ten animal health company whose products target and treat some of the most harmful animal diseases. This client develops health products across the board from companion animal to food animal treatments and drug therapies. Singota Solutions has been working with this client for over four years in service areas that include supply chain, production, development, and analytical testing. Problem The client submitted one of its products with promising data to the CVM for approval to begin Target Animal Safety (TAS) studies within the European Union. The product is administered using a syringe, where one syringe equals 1x the dose concentration. To achieve higher dose strengths for the study such as 2x and 3x, the client planned to use multiple syringes (i.e. 2x strength would be 2 syringes for the target animal). However, the CVM requested that another dose strength be administered, 2.5x, as an additional data point in the safety study. The TAS study was already scheduled and the target animals had been purchased and prepared for the study to start, in which the timing was critical. The client had limited options in order to come up with the additional data. They could either reformulate and manufacture the product so that they could have a syringe with 0.5x strength (costing them several thousands of dollars and setting them back for their study timeline) or come up with a creative solution to develop a 2.5x strength dose, keeping the end-user in mind and not compromising the integrity of the study. Additionally, they needed the syringes of each dose strength to be labeled, kitted, and delivered to the international site on time. Solution The client and Singota worked together to come up with a creative and cost-effective solution. Through open communication and idea-sharing, it was determined that the 0.5 point could be found on the syringe and marked so that the syringe could be expelled to the 0.5 point at the study site by the administrator. This made the most sense for maintaining sterility, economical reasons, and keeping the end-user in mind. Singota designed and manufactured a fixture to use during the labeling execution that would guide the placement of a 0.5 mark for the syringe. The client and Singota worked together to write a protocol and calculate upper and lower limits of tolerance for the 0.5 mark. These limits were then shown on the fixture so that the mark could be made accurately and quickly by those performing the labeling activities. The execution had to be efficient to meet a tight timeline and ensure international delivery to the site. Impact The syringes were labeled and delivered to the study site on time and with a protocol that each party was satisfied with. The project was executed in one month from the point of initial conversation, meeting the tight timeline. Ultimately, through a good partner relationship between Singota and the client and creative thinking on both ends, they were able to save thousands of dollars, meet a tough timeline, and not compromise their TAS study or the eventual approval of their product for commercial use.
Strengthening the Supply Chain through Partnership Case Study August 2016
In some cases, we found that our service providers have equally robust solutions which were already covered in their existing procedures. By evaluating, and when possible, approving these solutions for usage, we have allowed our partners to work within their areas of expertise to provide a more repeatable process and better quality service. It is not enough to utilize a solution that works well for us without giving the proper amount of consideration to the effects our choices may have to our downstream partners. Results As a result of using these three simple tools at Singota we have been able to forge long-lasting working relationships with our existing partners, as well as bring in very capable new partners as needed. If the relationship is purely transactional in nature, it is likely doomed to fail, whereas a relationship built on a foundation of truly working together and taking each other’s needs into account is sure to succeed. Not only is it important for your facility to feel confident in your partner’s abilities, it is equally important for them to feel confident that you are going to set them up to succeed. The benefits realized from forming these strong partnerships have greatly exceeded any of the time and effort used in creating them. Conclusion These are just a few examples of the type of partnerships which can greatly increase the quality of movements of material through the supply chain. It is important for all parties to realize that their piece of the process does not begin when materials arrive at the dock or end when materials are loaded onto the truck. It is the responsibility of all supply chain partners to ensure that processes are in place to both help strengthen their own handling of materials and aid upstream and downstream partners in moving products safely and seamlessly throughout the pharmaceutical supply chain.
Urgent Fulfillment of Laboratory Study Request Case Study August 2016
Urgent Fulfillment of Laboratory Study Request Singota Solutions was contacted by the Director of Pharmaceutical Development of a small, research[1]focused biotechnology company – a versatile company for its size, with three compounds deep in clinical trials for diverse indications. Singota had previously provided solubility testing for five new, experimental compounds for this client; that project went smoothly and helped establish a working relationship. Problem Shortly thereafter, the client urgently needed help when another laboratory suddenly withdrew from a stability testing program needed for a high-value preclinical toxicology study. The client needed seven-day stability data with its formulation to give the study site confidence in the project before they actually began administering doses to animals. There was a significant risk that without the data, the preclinical site would cancel the study, which was scheduled to start two weeks from the date when the client contacted Singota. Solution Singota’s project management team worked with the client to develop and document specific requirements, a project scope, a timetable, and a budget in a single day, only to find out from the client that the active pharmaceutical ingredient would not be available for delivery to Singota until just six days before the trial was set to begin. Thus, it was no longer possible to provide seven days of data. “As soon as the material came to our laboratory, we immediately began to formulate,” Ken Chomistek, Product and Analytical Development Manager, says. “We filled the large molecule formulations into vials, which we subjected to different thermal stability conditions. We performed our T0 testing and were able to do the T1 testing that Saturday. The following Monday morning, our scientists came in early to complete the T3 testing. The data from the time points were summarized, peer-reviewed, and quality assurance reviewed. We delivered this data such that the client and the study site were able to move forward with the animal study with confidence.” Singota continued the study to secure the rest of the seven days’ data as it became available. As a result, the study site proceeded with the animal testing based on three days of data, satisfied that the product was suitable for the toxicology study – saving the client the money it already had invested in the preclinical phase. “We had the expertise and the flexibility to meet our client’s requirements quickly,” Chomistek says. “Multiple people worked extended hours on the project. It also helped that the client’s project manager Singota Solutions | 2016 was based in California, because it gave us three additional hours [each day] of access to the client’s resources.” The commitment from the client included quick turnaround on requests for review of documents, such that testing could move from one step to the next with the required approvals. Singota was working to fulfill the client’s requirement; however, the client was looking to Singota for expert guidance on the design of the process of pulling everything together from the project requirements to the final stability report. The urgency of the project required Singota to have the organizational resources, committed team, and the flexibility to expedite the client’s work without delaying or compromising other ongoing development and analytical testing projects. Keys to Success: · Expert scientific and project management staff; · GLP procedures and cGMP analytical testing processes already in place; · Availability of additional internal scientific resources who were not engaged in the project, to provide peer review and impartial QA expertise; · Effective coordination between the Laboratory and Supply Chain service teams; · The experience as a contract service provider to balance resources and priorities such that extraordinary situations can be handled without exceeding our service capacity. Impact · The client was able to complete a scheduled GLP animal study, which represented a significant financial investment, while maintaining the confidence of the preclinical researchers at the study site. · The client maintained the schedule, and the momentum, of the preclinical development of the compound, which was in risk. · The stability study was Singota’s second project for this client, and the client has engaged Singota for four additional projects within a span of three months, including projects requiring other Singota facilities and services. Project Plan Formulation Protocol (GLP) (Sign-Off from Client) Filling (Test Vials) Execute (Sign-Off on Completed Formulation) Set-Up of Electronic Tracking in Stability Chambers ICH Stability Testing Data Recording Data Summarization/ Report Writing Peer Review QA Review Delivery to Client Process flow diagram of tasks required to complete client’s stability program