KBI Biopharma is expanding our cGMP clinical manufacturing facilities with state-of-the art equipment to include aseptic filling and lyophilization of Phase I and II clinical supplies. With the launch of these services we will provide seamless development of a variety of biopharmaceutical dosage forms, starting from preformulation to a finished product.

Our experienced Quality Assurance and Regulatory staff oversees the entire clinical manufacturing process and provides consulting for our as clients as needed.

Liquid Filling

• Wide range of vial sizes ranging from 1mL  to 100mL
• Coated or standard  13-mm, 20-mm and 28-mm stopper configurations
• Automated or Semi-automated filling equipment
• Flip-off or tear-away seals

Lyophilization

• Steam sterilizable lyophilizer accommodates 5,000 - 20,000 vials of 20mL and 1mL vials respectively
• Fully capable of scaling-up lyophilization cycles developed at KBI or elsewhere.