Drug Formulation from PCI

Drug Formulation Services

Formulation Process

Once the formulated product is ready for aseptic filling, it is transferred directly to the appropriate cGMP fill suite for aseptic filling into the final dosage form. Althea has the needed experience to design and deliver your clinical or commercial drug product as liquid or lyophilized formulation and in vials or syringes.

Althea is a leading expert in the field of drug formulation with unique capabilities and experience important to the formulation of your API material. Certain drug compounds may require complex drug formulation to overcome challenges with stability, efficacy, potency, or safety during clinical and commercial phases. Althea has extensive experience in implementing clients’ developed formulation methods into GMP compliant processes to ensure successful manufacturing scale-up.

Althea’s formulation scientists are highly knowledgeable in manufacturing various complex formulations, including liposomes & nanoparticles, conjugates, crystallized proteins, adjuvants, and viscous products. Althea is dedicated to drug formulation processes and has invested in five complex formulation suites. We leverage the use of microfluidizers, homogenizers, and tangential flow filtration to manufacture complex product formulations.

• Simple liquid formulation
• Lyophilized formulation
• Lyophilization cycle optimization
• Sustained release formulation
• Complex liquid formulation development including nano-emulsions
• Liposomes and nanoparticles
• Suspensions
• Conjugations of PEG and peptides