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One HEK of a viral vector to develop
Viral vector manufacturing presents many challenges related to HEK cell line development, fluid transfer and product viability in the cold chain.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
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Optimising iPS cell-based platelet manufacturing scale up
Large-scale platelet manufacturing must consider turbulent energy and shear stress as well as the undesired turbulent flow space within a bioreactor, the paper concluded.
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WHO proposes recommendations for preventing nitrosamine contamination
The World Health Organization (WHO)’s draft guidance on nitrosamines is applicable to manufacturers of excipients, active pharmaceutical ingredients (APIs) and finished pharmaceutical products.
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Benefits of 3D printing for personalised medicine formulation
A study has demonstrated how 3D printing can be used to manufacture tailored, safe, and effective treatments for patients with rare diseases via pharmaceutical compounding.
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Seasonal variation of microbial contamination in pharmaceutical cleanrooms
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
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Quality risk management in radiopharmaceutical production
A quality risk assessment of a Good Manufacturing Practice (GMP) radiopharmaceutical production site found that dispensing was the most critical phase of the process.
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Pharma Horizons: Environmental Monitoring
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
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Solution brief: Environmental monitoring software
Monitoring microbial contamination levels at various stages requires focused, independent software with extended controls over microbial management. Digital monitoring of contaminants and their sources helps understand microbial behavior and trends. Thus, a reinforced, data- driven environmental monitoring mechanism is the key to maintaining controlled lab spaces for microbial trend analysis.…
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Whitepaper: Manufacturing with Bruker’s Fourier PAT
Maximize the effectiveness and benefits of data-driven, real-time control, on-line NMR analysis coupled with process analytical technology (PAT).
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Manufacturing facility expansion to advance next-gen vaccine
The first South Korean vaccine manufacturing facility to achieve EU-GMP certification from the European Medicines Agency (EMA) is being expanded to support global supply of a pneumococcal conjugate vaccine.
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Live biotherapeutic products: bridging innovations and challenges in manufacturing
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
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Enhancing biopharma workflows with the power of UV/Vis spectroscopy
8 March 2024 | By Thermo Fisher Scientific
Discover the valuable role ultraviolet-visible spectroscopy can play in quickly and accurately monitoring a drug as it moves through the research & development workflow and enabling quality and regulatory compliance through the manufacturing process.
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Analytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum…
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Overcoming challenges of continuous antibody manufacture
During monoclonal antibody (mAb) manufacture, continuous flowsheets could offer ~20 percent–40 percent cost of goods (COG) saving over the batch process, for instance, during low commercial demand, a paper suggests.
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Nelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers
The new Pharmaceutical Center of Excellence from Nelson Labs offers state-of-the-art chemistry manufacturing and controls (CMC) analytical testing support.
