ACTIVE PHARMACEUTICAL INGREDIENTS (APIs)
Our chemical development scientists have the skill and experience to meet a wide range of outsourcing needs from the custom synthesis and scale-up of an existing route, to identification and development of new manufacturing routes. Each step of the development process is staffed by a highly qualified technical team that includes chemists, engineers and EHS. For every step, clinical phase appropriate objectives are identified and complete hazard assessments are performed to allow for safe production of your compounds.
>> Proof of Concept / Route Selection
>> Quality by Design (QbD) > Statistical Design of Experiments (DoE)
>> EHS Assessment
>> Scale-up of Existing Processes
>> Process Research, Development & Optimization
>> Analytical Development
>> Regulatory Filing Support
API Contract Manufacturing
cGMP Clinical & Commercial Manufacturing
Our understanding of the development process, and access to resources throughout its network of facilities, allows for the fast and reliable supply of APIs. We provide seamless technology transfer from research laboratories to our integrated network of reliable commercial cGMP manufacturing facilities, which offer a wide range of reactor capacity.
Few decisions in pharmaceutical operations are as critical as selecting the right cGMP Contract Manufacturer for your company’s Active Pharmaceutical Ingredient (API). APIs manufactured to cGMP standards for commercial sale must meet stringent requirements for identity, strength, quality and purity.
Our R&D department has a proven track record in preparing small quantities of your target compound. Since the initial synthesis may not be suitable to prepare larger quantities, we adapt to expanding requirements by adopting a synthesis that will best suit your needs.
If you already have a demonstrated route and need it reproduced in a timely and efficient manner, we surpass expectations by identifying and developing appropriate steps for scale-up and safety considerations.
Our customers benefit from extensive infrastructure with proven experience in producing commercial products that are distributed into worldwide regulated markets:
- Reactor pools with wide ranging flexibility, media compatibility (Hastelloy; glass-lined, steel) and temperature (-100°C to +200°C)
- Multiple product isolation technologies (centrifuge, filters, lyophilizer) with wide material compatibility (Hastelloy; stainless steel)
- Multiple drying options (agitated and static dryers)
- Multiple powder handling & finishing capabilities including sieving, blending & milling
- Handling of Highly Potent compounds down to exposure limits of 1ng/m3