Drug Product Manufacturing
Injection filling lines
Lyophilized production lines
Product packaging lines
TOT BIOPHARM has integrated with 4 filling lines, which consist of 3 lyophilization lines with isolators and one O-RABS line for injections. These lines strictly adhere to cGMP standards for the production of aseptic preparation. TOT BIOPHARM provides filling and packaging services for injections and lyophilized products from the development stage to commercialization.
– Adopt internationally renowned brands of production equipment, including Syntegon, Steriline, Kyowa, Getinge, and others.
– Disposable components are used for all parts that come into direct contact with the product. Ensuring compliance and preventing cross-contamination between different products.
– The team has undertaken and 100% successfully delivered for multiple product and commercial product manufacturing.
Injectables Filling Line
– Adopted Bosch automated filling line, which is applicable for GMP aseptic filling of 2R-20R vials, with running speed up to 300 vials/min.
– Automated filling line with open-Restricted Access Barrier System (o-RABS, for core area grade A environment in a grade B cleanroom)
– Use of disposable filling system, including mixing, filtration, storage and filling.
– The production line has been successfully running for 4 years, and has provided filling services for toxicology batch/IND batch/clinical batche/commercials products for multiple projects.
Lyophilized Production Line
– Equipped with grade OEB5 isolators for both pilot-scale and commercial-scale production workshops.
– Adopting isolator filling line, automatic loading and unloading lyophilizing system, and disposable filling system.
– Capable of producing lyophilized products in ranging from 2R to 50R, with a maximum running speed of 200 vials/min
– The production line adopts a rapid trnasfer interface (RTP), and equipped with online weighing and light protection functions. The pilot-scale workshop adopts 100% full weighing control mode.
– Equipped with 5 ㎡, 15 ㎡ and 20 ㎡ lyophilizers, all of which are equipped with fully automated loading and unloading systems.
Capacity
Injectables
|
Capacity of Injectables Production Vial (mL)
|
2
|
6
|
8
|
10
|
20
|
|
Filling speed（Vials/Hour）
|
24,000
|
18,000
|
18,000
|
15,000
|
12,000
|
Lyophilized Product
|
Vial (mL)
|
2
|
6/8
|
10/15
|
20
|
5㎡ lyophilizer
(Vials/batch)
|
22,000
|
11,000
|
9,000
|
6000
|
15㎡ lyophilizer
(Vials/batch)
|
64,000
|
33,000
|
28,000
|
18,000
|
20㎡ lyophilizer
(Vials/batch)
|
80,000
|
42,000
|
35,000
|
23,000
|
Equipment
Injection filling linesLyophilized production lines
Bosch bottle washing machine and Bosch tunnel oven