Brian Haney to address the question of choosing the right CMO for HPAPI manufacturing
For the first time, AMRI (Albany Molecular Research Inc.) will be attending and presenting at the HPAPI World Congress, to be held from 26-27 February in Munich, Germany. The event is focused on high potency API development and manufacture. Brian Haney, Ph.D., Director of Manufacturing at AMRI, will be giving a presentation entitled \'Choosing the Right CMO for HPAPI Manufacturing\'.
Dr Haney is responsible for leading the Commercial and Developmental manufacturing teams at AMRI. The Commercial Manufacturing team at AMRI produces commercial APIs and large-scale development programmes and the Developmental Manufacturing team completes small-volume commercial APIs and Phase 2/Phase 3 clinical programmes.
Dr Haney’s presentation will focus on the factors that are critical for expertise in HPAPI manufacturing, including solid evaluation of potency and toxicity of clinical compounds; state-of-the-art engineering controls; flexible containment strategies; competent cleaning and QC qualification; R&D support for HPAPI products; and organisational commitment to HPAPI manufacturing excellence.
There are several important points to contemplate when deciding on a Contract Manufacturing Organisation (CMO) to handle your High Potency Active Pharmaceutical Ingredients (HPAPIs). There are critical strengths that will have an impact on the success of an HPAPI programme, such as access to state-of-the-art GMP facilities with safeguards in place for employee safety and product quality, experience with developing flexible solutions to developmental challenges with HPAPIs, robust health and safety programmes for identifying critical hazards and developing smart solutions, and analytical expertise that can support early phase production.
AMRI, with its SMARTSOURCING approach, delivers a combination of these qualities to customers as a CMO that has extensive experience in the cGMP production of highly potent compounds. AMRI’s high potency research laboratories and GMP manufacturing facilities in Rensselaer, NY have the scientific and operational expertise in working safely with highly potent compounds. This is evidenced by its January 2010 certification by SafeBridge Consultants, a certification that applies to specific AMRI laboratories and manufacturing areas designed for the research, development and manufacture of potent compounds and certifies AMRI is competent and proficient in the safe handling of potent APIs.
AMRI has the experience to develop flexible solutions to developmental challenges with HPAPIs, despite the challenges in the development and manufacturing of cytotoxic and highly potent compounds. As one example, AMRI manufactured one high-potency compound for a customer using advanced supercritical carbon dioxide crystallisation technology to semi-continuously generate uniformly distributed micronised particles (d50 ~ 2µm) of a high potency drug substance. Engineering and process improvements resulted in a smooth, robust and validated commercial production process. Micronisation affords a novel, orally inhaled formulation that allows patients to safely self-administer the drug.
In addition, AMRI provides experienced analytical expertise to navigate and support early phase production. Most critical for manufacturing of HPAPIs is the ability to generate extremely sensitive compound-specific methods to support crossover studies when moving from one HPAPI to another in the manufacturing equipment. These capabilities also comprise cGMP analytical chemistry in the areas of chromatographic assay method and development and validations; stress degradation studies; impurity identification by liquid chromatography/mass spectrometry, gas chromatography/mass spectrometry and nuclear magnetic resonance; reference standard certifications; and wet chemistry tests. In the area of technology scale-up, AMRI also offers chemical and analytical development.