Founded in 2003, ProtoForm is a pharmaceutical contract research and development laboratory focused on formulation development of pharmaceutical products and related analytical test methods. Our mission is to significantly reduce the cost of formulation, preformulation, analytical testing and development, and stability testing by providing versatile research and development laboratories to our clients.
By applying modern theory and a quality by design philosophy to the development of every product, ProtoForm is able to deliver quality formulations and analytical methods along with comprehensive development reports. In addition, we offer experienced consulting at every step of your formulation development project.
ProtoForm's use of state-of-the-art equipment, such as a completely instrumented computer monitored tablet press, allows us to circumvent many formulation development problems and clearly identify critical process parameters for product scale-up and quality control.
Obtaining the necessary physiochemical and physicomechanical data before beginning the formulation process
At ProtoForm, we know it's vital that formulators obtain the most comprehensive physiochemical and physicomechanical data available prior to beginning the formulation process. To help with this, we have devised a comprehensive strategy that places formulation projects in the best position to ensure the development of quality and robust dosage forms—in a timeframe that is conducive to a successful product launch. This strategy is divided into three stages:
Our versatile research enviroment and equipment delivers comprehensive development data
ProtoForm follows a strict quality by design philosophy. We believe that quality and modern concepts must pervade all aspects of the formulation development process. By utilizing a versatile research environment, modern equipment, and comprehensive analytical analysis we are able to deliver quality formulations along with comprehensive development reports.
ProtoForm's staff has vast experience in a wide variety of formulations: from solid orals including immediate release and controlled release formulations, to suspensions and injectables. No matter how many prototypes we are working with, our extensive collection of equipment gives us the versatility to develop whatever you need. While developing these processes, we ensure the integration of the most state-of-the-art technologies available, such as an instrumented tablet press. This enables you to seamlessly transition through the product formulation stage of your project and get to market faster.
Keep your project on track with non-GMP stability testing
Stability is an important part of the development process. At ProtoForm, we realize that a formula is not a product unless chemical and physical stability have been tested and confirmed. For an ideal formulation development timeline, this analysis should be done during development. We know that failure to capture the necessary data can cause delays in your product launch timeline.
During formulation ProtoForm can assist with the necessary non-GMP stability testing to ensure that the product is viable and not prone to chemical or physical degradation. Our state-of-the-art equipment allows us to take detailed measurements of the chemical and physical stability of a formulation whether under accelerated or ambient conditions.
Our stability chambers are monitored 24 hours a day to ensure that your formulation development project remains on track.
Taking a quality-by-design approach to developing viable drug candidates
At ProtoForm, we take a quality-by-design approach to our development process. Taking advantage of the technology we have available on site in a non-GMP research environment gives us the ability to deliver comprehensive and robust formulations in a timely fashion, a convenience not available through other development laboratories that are hampered by red tape. Our experienced consulting gives you the knowledge and application of modern theory to deliver quality formulations. We pride ourselves on the education, experience, and training our staff has. You can, therefore, be assured that you're getting an experienced and versatile staff working on your project and can be confident of the quality of work our development process yields.
A vital component of our development strategy is that we take detailed measurements throughout the development process. This gives our clients tangible data throughout development and makes the process of scaling-up the drug candidate much more straightforward. For instance, we use a state-of-the-art computer monitored development tablet press that allows us to circumvent many formulation development problems, putting your project in a position to be successful further on in the process
Rent warehouse space and have your materials inventoried and tracked
ProtoForm has the capability to store any client’s materials in our warehouse. Whether it’s active pharmaceutical ingredients or excipients, we can store it in our facility and have it ready for whenever it’s needed by your team. Thanks to our tracking measures, we have the capability to track your materials during their time in storage at our facility. This means it’s not necessary that you remain in the area to monitor your materials. Instead, we take the reins and provide you with a timely point of reference for tracking material, taking inventory, checking quantities, and informing you of remaining amounts.
Warehousing services can be enormously useful if your company has minimal infrastructure under its ownership or a geographically-disparate staff. By renting our space, there’s no need to make any long-term commitments or investments in storage facilities—simply use our facility as you need it.
We develop and validate our testing methods to ensure accurate data is gathered for GMP compliance
ProtoForm provides a huge array of development and testing services to ensure your formulations are analyzed accurately at an affordable cost. We develop methods to conform to the exact specifications and requirements needed for your project. Likewise, we devise method validation protocols appropriate to gather the necessary data for GMP compliance.
Our vast wealth of experience and knowledge on staff enables us to characterize even the most difficult active pharmaceutical ingredient (API) and a wide variety of formulation products. We focus on exactly what you need from us. Even if your project requirements change, ProtoForm will adjust with you to ensure your project remains on schedule. Whether your company is a virtual pharmaceutical company or you simply outsource your research and development, we have the laboratory services you need to develop your analytical methods efficiently.
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