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ProMFG Drug Product (DP) Aseptic Fill & Finish

Multiple dosage forms

Comply with FDA, EMA, NMPA GMP regulations

Aseptic filling is a critical phase of sterile drug manufacturing in biopharmaceutical production. This is mainly due to its highly technology-driven process, and the potential safety to the end users.

ProBio offers ORABs-based, fully-automated final drug product filling under Current Good Manufacturing Practice (cGMP) conditions as defined by the worldwide regulatory agencies, including the FDA, EMA and NMPA.

49 External audit history
0 Observation pass EU QP audit

By Dec.2022

Advantages of aseptic Fill & Finish service

Special filling capability for nasal spray

√ All size of snap on

Filling capability for multiple dosage forms

√ Vial liquid filling
√ Vial lyophilized powder filling
√ Pre-filled syringes filling
√ Nasal spray filling

Advanced equipment

√ ORABs filling system from SYNTEGON
√ Lyophilizer from TOFFLON
√ Filling pump from Flexicon, sealer from Aptar

Flexible filling solutions for lyophilized powder

√ Validated container
√ Multiple volume (0.3-20ml)

cGMP Quality System

√ Comply with NMPA, FDA, EMA regulations
√ 49 times passed external client audits，>25% US/EU/AP clients，>75% projects apply CN and US markets
√ 0 Observation pass EU QP audit
*By Dec.2022

Capability summary of Drug Product Aseptic Fill & Finish service

	Liquid filling	Syringes filling	Nasal spray filling	Lyophilized powder filling
Filling system	ORABs filling line from SYNTEGON	ORABs filling line from SYNTEGON	Filling pump from Flexicon, sealer from Aptar	ORABs filling line from SYNTEGON Lyophilizer from TOFFLON
Filling volume	0.3ml-20ml	0.3ml-1ml	0.3-20ml	0.3ml-20ml
Container size	2R,6R,10R,20R	1ml	All size of snap on	2R,6R,10R,20R
Batch capability	30,000 pcs/batch (Nanjing) 192,000 pcs/batch (Zhenjiang)	28,880 pcs/batch (Nanjing) 192,000 pcs/batch (Zhenjiang)	6,000 pcs/batch	22,200 pcs/batch
Filling speed	125 pcs/min (Nanjing) 400 pcs/min (Zhenjiang)	120 pcs/min	/	/
Container	Vial	Pre-Filled Syringes（PFS）	Nasal Spray Bottle	Vial

Package of liquid filling for vial

Milestone	Service Content	Timeline（week）	Deliverables	QC Standard
Tech transfer（optional）	Tech transfer(risk assessment, tech transfer plan and report)	1-2 weeks	Technology transfer plan & report	Reports conform to quality specifications
	Partial analytical method transfer (including bioburden, endotoxin, concentration)	4 weeks
	Analytical method transfer and validation	7-10 weeks
DP production of injection	Process development of injection (optional)	2-3 weeks	Process specification, production batch record, COA, Structure confirmation report of reference.	Formulation conform to quality specifications
	DP GMP documents preparation (SOP & batch record) Fill & Finish of DP	1-2 weeks
		1 weeks
	Release test of DP (excl. bioassays)	2-3 weeks	COA
	Total (excluding optional)	3-3.5 weeks

Package of liquid filling for pre-filled syringes

Milestone	Service Content	Timeline（week）	Deliverables	QC Standard
Tech transfer（optional）	Tech transfer(risk assessment, tech transfer plan and report)	1-2 weeks	Technology transfer plan & report	Reports conform to quality specifications
	Partial analytical method transfer (including bioburden, endotoxin, concentration)	4 weeks
	Analytical method transfer and validation	7-10 weeks
DP production of injection	Process development of injection (optional)	2-3 weeks	Process specification, production batch record, COA, Structure confirmation report of reference.	Formulation conform to quality specifications
	DP GMP documents preparation (SOP & batch record) Fill & Finish of DP	1-2 weeks
		1 weeks
	Release test of DP (excl. bioassays)	2-3 weeks	COA
	Total (excluding optional)	3-3.5 weeks

Package of liquid filling for nasal spray

Milestone	Service Content	Timeline（week）	Deliverables	QC Standard
Tech transfer（optional）	Partial analytical method transfer (including bioburden, endotoxin, concentration)	4 weeks	Technology transfer plan & report	Reports conform to quality specifications
Tech transfer（optional）	Analytical method transfer and validation (optional)	7-10 weeks	Technology transfer plan & report	Reports conform to quality specifications
DP production of nasal spray	Process development of nasal spray per project (optional)	2-3 weeks	Process specification, production batch record, COA, Structure confirmation report of reference.	Formulation conform to quality specifications
	DP GMP documents preparation (SOP & batch record) Fill & Finish of DP	2-3 weeks
		1-2 weeks
	Release test of DP (excl. bioassays)	2-3 weeks	COA
	Total (excluding optional)	3-3.5 weeks

Package of lyophilized powder for vial

Milestone	Service Content	Timeline（week）	Deliverables	QC Standard
Tech transfer（optional）	Tech transfer(risk assessment, tech transfer plan and report)	1-2 weeks	Technology transfer plan & report	Reports conform to quality specifications
	Partial analytical method transfer (including bioburden, endotoxin, concentration)	4 weeks
	Analytical method transfer and validation	7-10 weeks
	Engineering batch production and release test	1-2 weeks
DP production of lyophilized powder	Lyophilized power process scale up (optional)	2-3 weeks	Process specification, production batch record, COA, Structure confirmation report of reference.	Formulation conform to quality specifications
	DP GMP documents preparation (SOP & batch record) Fill & Finish of DP	1-2 weeks
		1 weeks
	Release test of DP (excl. bioassays)	2-3 weeks	COA
	Total (excluding optional)	3-3.5 weeks