Contract Manufacturing Services

BINEX takes on responsibility of being a manufacturing partner for clients, aiding in the commercialization and global expansion of their product.

The process of developing pharmaceuticals can be complex and unpredictable, with various stages bringing both diversity and volatility. BINEX is committed to ensuring the consistent production of high-quality pharmaceuticals by rigorously managing our quality system. Drawing on years of production experience and technical expertise, we offer flexible services tailored to client’s needs.

Drug Substance

1. Capabilities that enable manufacturing from clinical to commercial product
   • Mammalian cell: 200 ~ 5,000L
   • Microbial: 180, 500L
2. Extensive production experience with various product types
3. Providing cell banking services (MCB/WCB) within a GMP facilities
4. GMP 환경 내 cell banking 제조(MCB/WCB) 서비스 제공

* STS: Stainless Steel Bioreactor / SUB: Single Use Bioreactor

Classification	Suite	Scale (type)	Train (W.V.) *
Mammalian	Suite 1	200 L (SUB)	200 L
		1,000 L (SUB)	200 L - 1,000 L
	Suite 2	500 L (STS)	500 L
	Suite 3	1,000 L (STS)	200 L - 1,000 L
	Suite 4	1,000 L (STS)	200 L - 1,000 L
	Suite 5	1,000 L (STS)	1,000 L
		1,000 L (STS)	200 L - 1,000 L
	Suite 6	5,000 L (STS)	1,000 L - 5,000 L
Microbial	Suite 7	180 L (STS)	180 L
	Suite 8	500 L (STS)	500 L

* W.V.: Working Volume

• Monoclonal
  Antibody
• Bispecific
  Antibody
• Fc-fusion
  Protein
• Recombinant
  Protein
• pDNA
  (gene therapy)
• Recombinant
  Vaccine
  (DNA vaccine)
• (Exosome,
  Viral Vector,
  etc.)

Process Flow

Buffer exchange, Filtration, Virus filtration, etc.

Upstream ProcessDownstream Process