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Bio Pharma

Bio Pharma

In general terms, it is defined as the pharma/medical drugs manufactured from or with the help of living cells are called as Biopharmaceuticals.

Following is the representative process flow of Biopharma process. It will slightly change depending in the respective cells, process& product requirements.

Bio Pharma Manufacturing

Upstream Process

Downstream Process

CIP

Inoculum Development

WCB

Media
Preparation

Seed-I

SIP

Nutrient Feed

Seed-II

Fermentation

Harvest

TFF/Cell
Clarification

Cell lysis

Buffer Preparation

CIP

Primary Purification

Second Purification

SIP

Chromat- ography

TFF/ Ultrafiltration

Sterile
Filtration

Product
Storage

Bio Kill

ETP

Depending on which cells are used, it gets bifurcated into two main types

1. Microbial processes:

A. Classical processes:

where natural microbial cells (Bacteria,Fungi,Yeast,Actinomycets etc) are used. All the antibiotics, vitamins, amino acids, enzymes, nucleic acids, statins etc. are the products from classical processes.

B. Recombinants:

where the microbes are genetically modified to get desired products in small volumes with higher titers in very quick batch time. Generally, they are called as Biologics products, they can be proteins, antibodies, vaccines, therapeutic enzymes, hormones, blood factors like critical products.

2. Cell culture processes:

Generally, very critical processes where mammalian cells or insect cells are used for manufacturing of very high end biotheraputics called as cell culture processes. Monoclonal antibodies are the good example of the same.
BioAspire can contribute to BioPharma industry with wide range of process solutions for various process unit operations.

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