Assessment of potential human health risks arising from the manufacture of a new licensed product in a shared manufacturing facility

Assessment of potential human health risks arising from the manufacture of a new licensed product in a shared manufacturing facility

Background The company intended to manufacture a new multi-ingredient pharmaceutical product at a shared manufacturing facility. Pharmaceutical good manufacturing practice (GMP) makes it incumbent on manufacturers of multiple pharmaceutical actives to ensure that cross-contamination of products does not present a health risk to patients. The…

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Health risk assessment of an excipient in an intravenously administered pharmaceutical product

Health risk assessment of an excipient in an intravenously administered pharmaceutical product

Background The client required qualification of the use of a nutrient-related compound as an excipient in an intravenously administered biological. Client An international pharmaceutical company. Project goals Bibra was asked to give an opinion on whether the presence of the excipient at the intended concentration…

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Provision of regular updates on the regulatory status of chemicals relevant to a client’s manufacturing process

Provision of regular updates on the regulatory status of chemicals relevant to a client’s manufacturing process

Background Regulatory information on chemicals is constantly changing and current awareness of a chemical’s regulatory status in the European Union and worldwide is key for responsible companies. Client A manufacturer of polymer products. Project goals To provide the client with a quarterly update on the…

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Responding to ECHA Evaluation draft decision for a UVCB

Responding to ECHA Evaluation draft decision for a UVCB

Background The client was sent a Draft Compliance Check Decision by ECHA, following an Evaluation, on one of their UVCB (Unknown or Variable Composition, Complex Reaction Products and Biological Materials) substances REACH registered at Annex X (in 2010). The REACH Standard Information Requirements (SIRs) identified…

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Biocompatibility and health risk assessment of a silver nanoparticle wound dressing

Biocompatibility and health risk assessment of a silver nanoparticle wound dressing

Background The client wished to market a new anti-bacterial dressing utilising nanoparticles of silver and intended to be worn for up to 30 days. Bibra was asked to assess a) the biocompatibility of the dressing and b) whether or not there would be any significant…

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Leachables in an intravenous buffer – a health risk assessment

Leachables in an intravenous buffer – a health risk assessment

Background The client was carrying out stability studies on a container-closure system (CCS) intended for long-term storage of an intravenous buffer that is added to various drug substances (in vials) immediately prior to administration to patients. Leachables data were available for various time points including day…

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Provision of 100’s of TPD2-compliant toxicity / addictiveness monographs for “e-liquid” ingredients

Provision of 100’s of TPD2-compliant toxicity / addictiveness monographs for “e-liquid” ingredients

Background There has been recent rapid expansion in the market for non-tobacco products that deliver inhaled nicotine, most notably, electronic cigarettes. These do not involve burning processes, rather converting an e‑liquid, containing nicotine and other excipients, into a vapour that is inhaled by the user. It…

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Calculation of HCVs for a packaging leachable

Calculation of HCVs for a packaging leachable

Background Bibra was asked to calculate health criteria values (HCVs) for a potential leachable from packaging for an intravenous pharmaceutical. Client A pharmaceutical company. Project goals To consider the critical systemic toxicity data on the potential leachable and to calculate HCVs for short- and long-term…

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Update of health risk assessment and Expert reports for an OTC veterinary product regulatory submission

Update of health risk assessment and Expert reports for an OTC veterinary product regulatory submission

Background The client wished to market a prescription veterinary treatment for dogs as an over-the-counter (OTC) product and was required to submit an updated data dossier complete with expert toxicological assessment. Client A large European company developing insecticidal formulations for use as Veterinary or Biocidal…

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Health risk assessment of aromatic hydrocarbon extractables

Health risk assessment of aromatic hydrocarbon extractables

Background The company had commissioned extractables studies on a stopper, used as part of the closure for the storage of a drug product for injection. Bibra was supplied with a laboratory analytical report describing the results of such studies on the test item. Client A…

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