Problem-solving and trouble-shooting on customers’ behalf is the focus of an entire support team – the Product and Process Support (PPS) group.
PPS Process Development focuses on developing specialty media concentrates and manufacturing process improvements. Cell culture studies, dry powder media feasibility studies, liquid media concentrates and lyophilization/desiccation studies are conducted by this team. The data from these studies are used for customer projects or for internal development and manufacturing process improvements.
| Concentrates, feasibility, packaging, stability: |
| |
Manufacturing process improvements (multiple to 1-part; hydration; homogeneity; purification) |
| |
Cell culture studies (media, feed supplements, stability) |
|
PPS Technical Transfer/Scale-Up activities include product transfer from non-cGMP to cGMP manufacturing, product/process scale-up, manufacturing process improvements and raw material specification review. Raw Material (RM) evaluation studies to define specifications, manufacturing feasibility/support studies, technical services investigation support, project support studies, pilot plant process studies and quality control support studies are performed by this team. This team collaborates with Plant/Production Managers as needed to ensure that manufacturing processes are consistent and efficient.
| Product transfer and process scale-up: |
| |
Millability, RM substitution, spec feasibility, scaleability, consistency |
| |
RM spec review, develop RM specs, confirm manufacturability and ease of use |
|
PPS Disposables focuses on BIOEAZE® single-use disposable systems and other packaging-related projects. Shipping studies, new film evaluation, investigation support, customer packaging studies, technical studies for support data and disposable component evaluations are performed or led by this group.
Shipping/storage studies, validations, new film & component studies, investigation support
PPS Special Projects supports serum projects as a first priority, focusing on new manufacturing technology and customer packaging, while staying up to date on changes in animal-origin regulations. This team will also be committed to projects related to peptones or hydrolysates.
| |
New manufacturing technology |
| |
Identifying alternative RMs, completing equivalency studies |
| |
Develop new formulating process for specific critical raw materials |
| |
Identify new filtration methods |
| |
Equivalency studies for alternatives |
| |
Peptones, recombinant growth factors/insulin |
|
|
|
|
|
|
Have a question or just curious?
|
|
