A Critical Step in the Biopharmaceutical Process — Sampling: Protect the Safety of Every Drug

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In the field of biopharmaceuticals, every drug from research and development to production concentrates the painstaking efforts of countless researchers, and it also carries patients' expectations for health. In this long and rigorous production chain, there is a seemingly small but crucial link. It is like a "scout" of drug quality, silently guarding the safety and effectiveness of drugs. This link is the sampling of the biopharmaceutical process.

Our "scouts" will focus on conducting operations at the following four core links

The First Link: The Upstream "Cell Factory" Monitoring Room

Sampling Target: Culture medium for cell growth.
Detective Task:

1. Counting Cells: How do cells live? Is the quantity enough? (viable cell density, survival rate)

2. Measure "blood sugar": Is the nutrition (glucose) that cells "eat" enough? Is there too much metabolic waste (lactic acid) that "pulls"?

3. Check the Output (product concentration): Is the "micro factory" efficient in producing the target drug?

Importance: Just like caring for a newborn baby, one must always pay attention to its health and growth environment.

The Second Link: Downstream "Purification and Refining" Laboratory

Sampling Target: the solution after passing through various chromatography columns and filtration membranes.
Detective Task:

1. Catch the "Bad Guys": The drug is purified, but are there "bad guys" such as mixed proteins (host cell protein HCP) and cell debris (DNA)?

2. Calculate "Recovery": how many valuable drugs do we lose in one step of purification? What is the recovery rate?

3. Verify Identity: Is the purified drug structure correct? Is there any aggregation or breakage? (Purity, Polymer)

Importance: This is the process of "gold rush". To separate gold (drugs) from a large amount of sediment (impurities), it must be tested step by step.

The Third Link: Virus "Security Door"

Sampling Target: Samples before and after virus inactivation/removal treatment.
Detective Task: Assess whether the inactivation process is absolutely effective and how many orders of magnitude (log drop value LRV) of potential viruses can be eliminated.
Importance: This is a life-and-death defense line related to the safety of patients' lives. Sampling and testing must be carried out at the highest safety level.

The Fourth Link: The Final Finished Product "Assessment Station"

Sampling Target: Filled finished drug bottles.
Detective Task: This is the ultimate "graduation exam".

1. Check Appearance: The clarity of the solution and the absence of visible particulates.

2. Test Content: Are sterility inspection and endotoxin up to standard?

3. Identity Guarantee: All core indicators such as drug identification, purity, and potency must be 100% qualified.

4. Check the Packaging: Is the tightness of the bottle good, and can it guarantee sterility?

Importance: This is the last gate to be released to the market. If any item is unqualified, the entire batch of drugs will be scrapped.

In view of the above sampling requirements, BioLink has a complete set of solutions:

Stainless Steel System Sampling Products: Sampling Base

Closed sterile sampling;
Pre-assembled and ready to use;
Simple and easy to use with ergonomic design;
Can be mounted to autoclave resistant stainless steel equipment and is SIP resistant.

figure-1-biohub-sterile-sampling-base-and-application.jpg

Figure 1: BioHub® Sterile Sampling Base and Application

Stainless Steel System Sampling Products: Sampling Consumables

Sampling Bottle

Material: PC;
Volume: 20 mL to 250 mL;
Working Temperature: -80 ℃ ~ 121 ℃.

Figure 2: BioHub® Single-use Needle Sampling Bottle

Sampling Bag

Liquid Contact Layer: ULDPE or EVA;
Volume: 50 mL-1 L;
Working Temperature: -80 ℃ ~ 60 ℃.

Figure 3: BioHub® Single-use Sampling Bag

Stainless Steel System Sampling Products: Sampling Consumables

Figures 4, 5: BioHub® Single-use Sampling Bag/Bottle

Single-use System Sampling Products: Sampling Consumables

Figures 6, 7: BioHub® Single-use Multi-bag/bottle

References

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