Azopharma
Azopharma Product Development Group

Headquarters
Hollywood, FL

Location(s)
Hollywood, FL, Miramar FL, St. Louis, MO, Newark, NJ, Colorado Springs, CO, Welwyn Garden City, UK

Years in Drug Formulation
15 Years

Web site 

Company's role in drug discovery and developmnet
Azopharma Product Development Group provides comprehensive drug development services from discovery to commercialization. In preclinical we can synthesize compounds, screen candidates, establish toxicity, and perform metabolism studies in animals. We also provide full bioanalytical services including method development and validation. Our analytical team supports development through CMC services including characterization and stability. We specialize in developing formulations for all major dosage forms and can supply clinical trial material for human trials at our clinical pharmacology facility. Our team of experts can also manage your clinical trials as well as provide regulatory support through all phases of development.

Company's experience and expertise in drug formulation
We have assembled a team industry leading formulation experts with decades of experience in all areas of the pharmaceutical industry. Azopharma provides comprehensive formulation services for all major dosage forms including solid oral, semi-solid, topical, liquid, inhalation, cytotoxic, controlled substances, and transdermals. Azopharma’s state of the art facilities include GMP formulation and manufacturing suites with on-site analytical teams to support prototype development. Our equipment is second to none and includes research and manufacturing scale specialty presses. The Azopharma formulation team is also dedicated to keeping up with the latest advances in the industry such as Xcelodose.

Relationship with pharma companies
Azopharma provides fee for service formulation activities to the pharmaceutical industry. We are dedicated to advancing our client’s objectives whether it is developing a formulation for a new product or enhancing the formulation of an existing product for lifecycle management purposes. Azopharma is flexible in accommodating its customer’s variable and ever changing needs. Many clients come to us on a project by project basis. However, we can also provide a dedicated team of scientists to work full time on a client’s pipeline of products. Essentially, we can act as an extension of their existing formulation department or fully take over all of their formulation activities. Additionally, we can integrate our formulation capabilities with other ancillary drug development activities such CMC programs and clinical trials to provide a complete product development solution.

Factors critical for drug formulation
For Azopharma the most critical factor in drug formulation are meeting client’s expectations regarding timeliness and quality. These issues are addressed by our world class project management team. Our project managers are integrated into the day to day activities of formulation. From preliminary development to the analytical support, our project managers are expediting communication internally and with our clients. Along with assembling a world class formulations team, we have found that most issues in formulation can be addressed by proactive communication of all stake holders.

Scientific/business/regulatory trends impacting drug formulation
It’s an exciting time in the field of formulation. Technologies are advancing at a very fast rate to keep pace with the need for new products as old ones come off patent. Compounding this is that many of the “easier” molecules, like those which are easily soluble, have already been exploited. The formulators at Azopharma have become very creative in dealing with these problems and incorporate new technologies for solubility enhancement and modified release. Additionally, Azopharma’s formulators are taking on a new role to expedite development process for early screening activities. Two specific examples are Xcelodose and Microdosing.

In these uncertain economic times, outsourcing formulation and other activities is becoming an increasingly important way of managing development risk. Azopharma is uniquely positioned to take advantage of this trend due to the breadth of its formulation expertise, as well as its comprehensive product development services. Additionally, the pharmaceutical industry wants to be more efficient in the development process. Formulation in the past was often a mid to later stage activity. However, now formulation technology is being co-opted for “quick” screening activities. For example, Azopharma uses Xcelodose technology to minimize the use of active material and reduce other development activities.

Success story
A sponsor requested that Azopharma provide formulation support for an early stage biotechnology drug candidate entering pivotal clinical trials in 5 months. The dose of the biotherapeutic was 2.0 mg/kg. The clinical protocol required healthy male volunteers in the range of 70 to 100 Kg (140 to 200 mg dose). The current route of administration was infusion of a 5 mg/mL solution (28 to 40 mL infusion). The sponsor desired to increase the concentration of the therapeutic to 100 mg/mL, thereby, allowing a maximum injection of 2.0 mL.

Azopharma’s scientists identified three key issues to investigate during the development of a revised formulation. Early studies focused on stability, viscosity of the solution, and aggregation of the active biotherapeutic. Azopharma recommended the evaluation of two routes of administration, intra-muscular and subcutaneous.

Azopharma used a variety of techniques to identify the obvious and latent instabilities of the biotherapeutic in various vehicles. As a result, a new 100 mg/mL dosage form was successfully developed within the desired timeframe. The biotherapeutic entered Phase 1 with the new formulation using the Sub-Q route of administration. The accelerated stability data and newly developed stability indicating assay provided support for the IND file.

How will roles of CROs and contract manufacturers change over the next few years?
We see further consolidation of big pharma and streamlining of the development process. The pharmaceutical industry will continue to trend away from development infrastructure in order to minimize risk. Azopharma is uniquely positioned to take advantage of this trend due to its comprehensive development capabilities from discovery to commercialization.