John Fowler discuses how Pii supports complex therapeutic programs, from scale-up through commercialization.

Cultural Transformations a Necessity to Support Complex Therapeutics Through Development and Manufacturing

Services necessary to carry out new programs for complex molecules, from scale-up to commercialization.

Lyophilization capabilities that can help ensure quality through processing.

Resources to support efficient secondary pharmaceutical packaging.  

Videos

President and CEO of Pharmaceutics International, Inc. (Pii), John Fowler, reacts to the agility and flexibility needed to support the development and manufacture of today's complex biotherapeutics.

Pii’s Robotic Aseptic Fill-Finish line provides reliable and flexible processing, minimizes manual interventions, and reduces product losses, common at the beginning and end of batch manufacturing. The Robotic Aseptic Fill-Finish line compliments Pii’s larger volume production lines by offering clinical fill-finish manufacturing of cartridges, vials and syringes. With Batch Sizes from 1L – 1000L, Pii is your preferred Aseptic Fill-Finish CDMO. 

Pii’s Bosch Aseptic Fill-Finish line is perfect for handling large commercialization batches, filling up to 150-200 vials per minute. The Bosch accommodates both Ready to Use (RTU) and Ready to Sterilize (RTS) vials 2mL – 100mL.Pii is your preferred Aseptic Fill-Finish CDMO. 

Pii’s M and O Perry Aseptic Fill-Finish line offers clinical and commercial fill-finish manufacturing of vials filling up to 40 vials per minute. This line supports batch sizes from (1L – 500L) and the ability to fill a vial size range from 3mL – 100mL. Pii is your preferred Aseptic Fill-Finish CDMO. 

Pii’s Aseptic Pre-Filled Syringe Fill-Finish

Pii’s Groninger Syringe Fill-Finish line supports a range of injectables from clinical to commercial batch sizes up to 50,000 syringes per day with pre-filled syringe sizes ranging from 1mL – 10mL. Pii is your preferred Aseptic Fill-Finish CDMO. 

Robotic Aseptic Fill-Finish: A Game-Changing Flexible Solution

http://www.pharmtech.com/pt_w/early_phase

	Getting your product to the clinic fast is always a key driver in pharmaceutical product development. Producing it right the first time is another key driver. In this webcast, Pii will discuss options for delivering on both of these critical requirements and will talk about the challenges clients have in producing efficient and flexible sterile product filling solutions.

		Review the experience, technologies and solutions necessary to maximize yield and reduce contamination risks in small-scale sterile filling operations

		Gain knowledge on how to get drugs faster to clinic and how to get them done properly the first time through

		Learn about Pii’s, AST GENiSYS® R technology, and how this technology can support your clinical product requirements

Samuel Chia, Director Aseptic Manufacturing, Pii

	Joe Hoff, Chairman & CEO Automated Systems, Tacoma (AST)

Thursday, Mar. 19, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET

	On demand available after airing until Mar. 19, 2021

Webcasts

Learn techniques on getting your drug product to market faster and more efficiently.
Live: Thursday, Mar. 19, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
On demand available after airing until Mar. 19, 2021 
Register free


Sterile Filling Challenges for Early-Phase Product Development

	Pii offers product development and cGMP manufacturing services for dosage forms including steriles, liquids, semi-solids, and oral solids, applying more than 25 years of scientific know-how, regulatory filing experience, and deep commitment to customer relationships. 

	Recognizing the growing need for flexible aseptic production systems that can efficiently process high-quality, medium-sized clinical and commercial batches, we have expanded our capabilities and capacity with investment in a new, fully-robotic aseptic filling line. With the addition of the GENiSYS

 R filling machine, we can process pre-sterilized, ready-to-fill vials, syringes, and cartridges on a single machine, delivering greater speed, efficiency, and flexibility in aseptic, toxic, and cytotoxic drug products.

	This latest expansion in our portfolio of services reflects our constant commitment to delivering high-quality sterile drug product for customers on aggressive timelines. Discover how our depth of experience, know-how, and integrity as a CDMO partner can optimize the development of your sterile product.


	10819 Gilroy Road
	Hunt Valley, Maryland 21031 USA
	tel. +1 410 584 0001
	bd@pharm-int.com
	

Articles

Discover how Pii’s expanded aseptic processing capabilities and capacity can bring greater efficiency, flexibility, and reliability to the development of your sterile drug product.

Know-How and expanded Capacity to Advance Sterile Products

	With 25 years of experience and exceptional know-how within our team, Pii is a CDMO that supports customers in product development and clinical to commercial-scale manufacture across a range of dosage forms, including liquid and lyophilized steriles and challenging liquid, semi-solid and oral solids, including potents, hormones, and controlled substances.

	Our capabilities in aseptic fill-finish have been expanded and strengthened with the installation and validation of a fully-robotic filling line, offering greater capacity, efficiency, and flexibility in bringing sterile products to market.

	With experience and integrity in our leadership team and across our operations, we bring total commitment to your product and your needs, and a pledge of quality, reliability, transparency, and responsiveness. We have the track record and knowledge to navigate the regulatory filing process, and can assure you that nothing is more important to us than our relationship with you and your product’s success.

		Controlled Substances (Schedules I – V)

		Dosage Form Development & Manufacturing


	10819 Gilroy Road
	Hunt Valley, Maryland 21031, USA
	tel. +1.410.584.0001
	bd@pharm-int.com
	

Pii brings 25 years of scientific and regulatory know-how to the development of your liquid and lyophilized sterile, semi-solid, and oral solid dose drug product, including expanded sterile fill-finish capacity.