The bulk harvest is a critical stage of any manufacturing process. It is essential that, during this stage, you retain as much of your material as possible, so you can meet regulatory requirements. At SGS, our specialists will work closely with you and your team so you can be sure you are using the minimum volume of required assays.
Services our biosafety team can offer
Microbial contaminants:
- Mycoplasma via culture and quantitative polymerase chain reaction (qPCR) (USP 63 Phar.Eur.2.6.7)
- Mycobacteria via culture and validated quantitative polymerase chain reaction (qPCR)
- Spiroplasma
- Sterility
Adventitious virus detection:
- In vitro cell culture assays
- Hemadsorption and hemagglutination
Specific virus detection:
- >300 GMP validated virus specific quantitative polymerase chain reaction (qPCR) assays
Identity of control cells:
- Random amplified polymorphic DNA (RAPD)
- Nucleic acid testing (NAT)
Retrovirus detection:
- Fluorescent product enhanced reverse transcriptase (F-PERT) and quantitative real time fluorescent product enhanced reverse transcriptase (Q-PERT)
- Transmission electron microscopy
- Infectious retroviruses/Mus-Dunni/HEK293 cocultivation