The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics.
Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.
How will the move to more specialized and personalized medicines impact drug delivery and dosage forms?
The workshop focused on topics specific to biologics, including particulate control and determination, becoming the first workshop of its kind for the organization.
Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.
The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.
FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.
This guest blog was written by Christie Bloomquist is a partner in health practice at Hogan Lovells, a global legal practice firm based in Washington DC.
The procurement organization rethinks sourcing for maximum efficiency and results.
Why is the correct storage of stem cells so important for the future of medical innovation?
Stem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.
The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly.
The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.
Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.
Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.
The demand for CGMP production of biopharmaceuticals is at an all-time high.
Successfully taking a new chemical entity from proof-of-concept to commercialization requires the biopharmaceutical company to carefully evaluate a contract services provider's formulation department and ability to become a fully integrated supplier.
This comparative study suggests that pregelatinized starches are superior to natural starches in terms of improving the plastic deformation in tablet formulations during compression.
This study attempts to determine the combination of excipients found in commercial ASA products that would be suitable for use in an aqueous enteric film­coating process.
This study attempts to determine the combination of excipients found in commercial ASA products that would be suitable for use in an aqueous enteric film­coating process.
To aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.
The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
The authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
The authors provide an overview of formulating latex dispersions with pigments for the film coating of solid dosage forms, including factors such as regulation, methods for assessing stability, and surface chemistry.
The authors provide an overview of formulating latex dispersions with pigments for the film coating of solid dosage forms, including factors such as regulation, methods for assessing stability, and surface chemistry.
To aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.