BASF Biopharma Ingredients Portfolio – High Quality Raw Materials for Biopharmaceutical Manufacturing
Biopharmaceutical manufacturing processes require high-quality raw materials delivered through a transparent and reliable supply chain, supported by experts. BASF Biopharma Ingredients is committed to meeting your requirements for every ingredient we supply to the biologics industry.
Our Research & Development Team
- Designs new products that solve bioprocessing and formulation challenges
- Drives new product development pipeline
- Provides support for a wide variety of other projects and topics
Our Technical Teams
- Provide deep insights on surfactant chemistry and its use in bioprocessing
- Can access BASF Scientifi c Network, which is used for tackling the bigger challenges
Our Quality & Regulatory Team
- Has a global & regional presence to support customer drug filing
- Works closely with manufacturing sites to ensure GMP compliance
BASF GMP Products Suitable for Use as Ingredients in Biopharma Manufacturing
| Product | Monograph Quality |
|---|---|
| Kolliphor® P188 Bio – poloxamer suitable for a broad range of applications, including cell culture shear protectant and excipient in final drug formulations | Ph. Eur., USP, JPE 1 , ChP |
| Kolliphor® P188 Cell Culture – poloxamer designed for functionality in a broader range of CHO & HEK culture systems | Ph. Eur., USP, JPE |
| Soluplus® – anionic graft copolymer shown to provide excellent functionality in sensitive stem cell therapy systems | N/A |
| Kolliphor® SLS – popular all-purpose anionic surfactant, also known as sodium dodecyl sulfate (SDS) | Ph. Eur., USP, JPE |
| Kolliphor® HS-15 – surfactant designed as nonionic solubilizer, and redispersingvagent for injectable formulations | Ph. Eur., USP |
| Kolliphor® ELP – surfactant designed as nonionic solubilizer, purified for use in sensitive applications including injectable formulations | Ph. Eur., USP |
- Manufactured in the USA and Germany according to IPEC-GMP guidelines
- Enhanced packaging & testing requirements to meet biopharma requirements
- History of use in pharmaceutical manufacturing
- Regulatory documentation, registration, and submission support
Soluplus® Application Spotlight
Our R&D partnerships enable studies that work to establish protocols and overcome challenges to scale-up for future therapies. BASF Soluplus® was featured in a recent Nature publication 3 where it was shown to have advantages in the long-term ex-vivo expansion of HSCs in chemically defined media.
Introducing the Family of Poloxamers Designed for Biopharmaceutical Manufacturing
Product Spotlight
Functionally, Kolliphor® P188 Bio was designed for performance consistency when used as a shear protectant in upstream CHO cell culture. However, Kolliphor® P188 Bio is suitable for use with many other cell types, including NSO, HEK293, and insect cell lines, at a wide variety of concentrations. This versatile surfactant is also known to decrease cell clumping upstream. The long history of use ensures protocols for downstream clearance and analytic testing afterwards are readily available.
The effects of shear stress during bulk fluid transfer can be mitigated with addition of poloxamer 188.
To further enable continuity of product use across the biomanufacturing process, Kolliphor® P188 Bio is manufactured in accordance with IPEC GMP guidelines, at a site inspected by the FDA. Kolliphor® P188 Bio is widely used in drug formulations, including proteins, peptides, antibodies, viral vectors, genes, and cells.
Did you know…
BASF Scientists were the original inventors* of poloxamer
chemistry, and we have been improving on it ever since!
* US683227A, Donald R Jackson & Lester G Lundsted, Mixtures of novel conjugated polyoxyethylenepolyoxypropylene compounds, 1957.
As critical parameters controlling shear protection performance continue to be investigated, BASF converts our new learning into innovative products enabling your bioprocess applications, now and into the future. Kolliphor® P188 Cell Culture was designed to target a lower average molecular weight while maintaining batch-to batch consistency when used as a shear protectant in upstream CHO cell culture. However, Kolliphor® P188 Cell Culture is suitable for use with many other cell types across a variety of reactor types and process steps.
Poloxamer 188 is a popular surfactant used across the various manufacturing process steps. It is a synthetic block copolymer of ethylene oxide and propylene oxide, solidified to form a white to almost prill / powder.
See the full brochure on “Biopharma Ingredients Portfolio by BASF” here
