Bio/Pharma Product Testing Services >> Manufacturing and Process Validation >> Residuals Testing for Bioprocess Validation

Residuals Testing for Bioprocess Validation

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Effective removal of impurities is a critical step in any drug development process. And because residual impurities are typically present at low concentrations within complex matrices, their detection and quantification can be quite difficult. For this reason, process validation studies require a broad set of testing capabilities and expertise.

Whether you have impurities that are being introduced in upstream steps from culture growth and harvest, in the downstream processes, or through single-use technology, we have the breadth of capabilities and depth of industry knowledge to support all of your process validation testing needs.

Why Choose Eurofins BioPharma Product Testing?

  • We have developed and qualified thousands of highly sensitive and selective methods that can help shorten your process validation timelines and minimize costs.
  • Our 30-year history of cGMP regulatory compliance ensures delivery of the highest quality data.
  • Our expertise in biochemistry, molecular & cell biology, virology and chemistry provides you with a single source for all of your validation testing needs.

Experience

Upstream Residuals
rDNA, Benzonase, Host Cell Protein (HCP), Protein A, Human Serum Albumin (HSA), Bovine Serum Albumin (BSA)

Downstream Residuals

  • Antibiotics: Kanamycin, ampicillin, penicillin, chloramphenicol, gentamicin sulfate, amphotericin B, hygromycin B, plasmocin, tetracycline, methotrexate, neomycin
  • Buffers: Tris, taurine, phosphate, sulfate, ammonia, cyanide, acetate, iodate, citraconic acid, citrate, imidazole, HEPES, glucoheptonate, sucrose, trehalose, glucose, inositol, histadine, formaldehyde, glyceraldehyde
  • Surfactants & Antifoams: Triton-X, Pluronic, Tween 20 & 80, Antifoam A,B,C, polyglycol P2000, Antifoam DF204
  • Process-Enhancing and Purification Agents: IPTG, DTT, urea, guanidine, DOTA, EDTA, m-cresol, phenol, glutathionine, benzamidine, methionine sulfoximine, beta-glucan, PEG, tropolone, isopropyl alcohol, glycerol, PPG
  • Solvents: Deimethyl formamide, pyridine, DMSO, USP and Custom Methods
  • Metals: Single or multiple element determinations by ICP-OES and ICP-MS, USP

Extractables and Leachables
Design and execution of forced extraction, controlled extraction, simulation studies and leaching studies