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Manufacturing

Affinivax launches new conjugate vaccine for Ggobal impact on infectious diseases Affinivax, a biotechnology company dedicated to developing novel vaccines, has announced its launch with a $4m investment from the Bill & Melinda Gates Foundation.
Production & Manufacturing > Manufacturing > News
Cirrus Pharmaceuticals to invest in cGMP manufacturing suite in US Cirrus Pharmaceuticals, a Kemwell company, which is a 100% services oriented company providing pharmaceutical contract development and manufacturing services, has announced that it will be investing in a flexible cGMP suite in its facility in RTP, North Carolina.
Production & Manufacturing > Manufacturing > News AstraZeneca's XIGDUO XR combination diabetes drug gets FDA approval By PBR Staff Writer
British drugmaker AstraZeneca has received approval from the US Food and Drug Administration for its once-daily XIGDUO XR drug to treat adults with type 2 diabetes.
Production & Manufacturing > Manufacturing > News
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Latest Manufacturing News and Insight

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GlaxoSmithKline introduces Incruse Ellipta in UK for COPD patients
By PBR Staff Writer
GlaxoSmithKline (GSK) has launched a new once-daily bronchodilator treatment, Incruse Ellipta (umeclidinium) in the UK, to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Production & Manufacturing > Manufacturing > News
Bristol-Myers Squibb expands manufacturing agreement with Lonza
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has expanded its existing multi-year biologics manufacturing agreement with Swiss chemicals and biotechnology firm Lonza.
Production & Manufacturing > Manufacturing > News
GxP Infrastructure Outsourcing
Infrastructure complexity is increasing and life sciences companies are under a constant pressure to cut costs. Outsourcing is a lever for cutting costs and freeing up internal resources for tasks other than daily operations. NNIT deliver integrated infrastructure outsourcing and application outsourcing that can improve your business processes to reduce costs, free up resources, minimise risk and shorten time to market.
Production & Manufacturing > Manufacturing > Products
Serialisation
Millions of people die every year due to erroneous treatment with counterfeit drugs. To break the cycle with counterfeit drugs, authorities in most major markets are putting regulations into place to enhance patient’s safety. NNIT and NNE Pharmaplan offer a full end-to-end Track and Trace programme covering all aspects of serialisation, from packaging to the point of dispense. Learn more about NNIT and find out how you comply with the serialisation requirements.
Production & Manufacturing > Manufacturing > Products
Quality Management
Effective quality management processes in the life science industry are critical to meet the intense regulatory requirements.NNIT can ensure you have the highest level of inspection readiness with full document compliance and validation, according to FDA and EMA requirements.
Production & Manufacturing > Manufacturing > Products
Regulatory Affairs
The burden of regulation imposed by national health system legislation and regulatory authorities is continually growing. NNIT can help you use IT to comply with new and upcoming regulations from drug development and regulatory submissions to post-marketing while ensuring that you can manage your data and improve collaboration across your organisation.
Production & Manufacturing > Manufacturing > Products
Drug Development
Transforming a compound into a drug is a massive investment. An integrated IT strategy across your clinical value chain can maximise this investment and speed up time to market.
Production & Manufacturing > Manufacturing > Products
Case Stories
NNIT started life as the IT department of an international pharmaceutical company. This has given us an insiders’ understanding of the way the life sciences industry works. Our people are united by a high level of IT expertise coupled with a commitment to deliver the highest level of quality. In short, we go out of our way to make sure your IT processes increase your business efficiency and support your organisational ambitions.
Production & Manufacturing > Manufacturing > Case Studies
Molnár-Institute - DryLab HPLC Method Development Software
Founded in 1981, Molnár-Institute focuses on strategies for improving the efficiency and success of modern HPLC. Our state-of-the-art HPLC modelling software, DryLab supports chromatographers worldwide in method development, optimisation, troubleshooting, robustness testing, and training.
Production & Manufacturing > Manufacturing > Suppliers
Clinuvel gets EMA approval for Scenesse to treat erythropoietic protoporphyria
By PBR Staff Writer
Australia-based Clinuvel Pharmaceuticals has received regulatory approval from the European Medicines Agency (EMA) for its Scenesse (afamelanotide 16mg) drug to treat adult patients with rare skin disorder erythropoietic protoporphyria (EPP).
Production & Manufacturing > Manufacturing > News
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