NNE Pharmaplan | Date: 2017-08-09
The present invention relates to a pharmaceutical adaptor system. The pharmaceutical adaptor system comprises a syringe assembly having an axial extension and comprising a first end part and a second end part, the first end part having a male tubular projection, the syringe assembly comprising a syringe and a connecting element having a first mechanical connection part, a unit such as a needle, a vial, a catheter or an IV line, and an adaptor providing fluid communication between the syringe and the unit and having a second mechanical connection part configured to engage with the first mechanical connection part in an engagement direction, thereby preventing movement by the first and second connection parts along the axial extension, wherein the adaptor comprises a sealing element configured to receive the male tubular projection. The present invention also relates to a pharmaceutical kit system comprising a pharmaceutical adaptor system according to the present invention.
NNE Pharmaplan | Date: 2017-05-03
The present invention relates to a single-use auto-injector for injection of a dosage of a drug into a human body, comprising a housing, and a dosing unit arranged in at least part of the housing, the dosing unit comprising, a needle, a drug container comprising the drug, a piston movable in the container, a first mechanical power supply for supplying a first mechanical force for moving the piston to deliver a drug to the human body, an activation mechanism configured to release the first mechanical power of the first mechanical power supply, and a mechanical brake for controlling the movement of the piston, wherein the auto-injector comprises a second mechanical power supply for supplying a second mechanical force, the auto-injector having, a first state in which the needle is protected from needle damage or contamination, a second state in which the needle is ready to penetrate the human body for dosing the drug, a third state in which the needle has penetrated the human body and is ready to dose, and a fourth state in which the needle is shielded to avoid unintended needle sticks, wherein the second mechanical power supply is configured to shift state of the auto-injector from the third state to the fourth state by releasing the second mechanical power.
Alleso M.,Lundbeck |
Alleso M.,NNE Pharmaplan |
Holm R.,Lundbeck |
European Journal of Pharmaceutical Sciences | Year: 2016
Due to the complexity and difficulties associated with the mechanistic modeling of roller compaction process for scale-up, an innovative equipment approach is to keep roll diameter fixed between scales and instead vary the roll width. Assuming a fixed gap and roll force, this approach should create similar conditions for the nip regions of the two compactor scales, and thus result in a scale-reproducible ribbon porosity. In the present work a non-destructive laser-based technique was used to measure the ribbon porosity at-line with high precision and high accuracy as confirmed by an initial comparison to a well-established volume displacement oil intrusion method. The ribbon porosity was found to be scale-independent when comparing the average porosity of a group of ribbon samples (n = 12) from small-scale (Mini-Pactor®) to large-scale (Macro-Pactor®). A higher standard deviation of ribbons fragment porosities from the large-scale roller compactor was attributed to minor variations in powder densification across the roll width. With the intention to reproduce ribbon porosity from one scale to the other, process settings of roll force and gap size applied to the Mini-Pactor® (and identified during formulation development) were therefore directly transferrable to subsequent commercial scale production on the Macro-Pactor®. This creates a better link between formulation development and tech transfer and decreases the number of batches needed to establish the parameter settings of the commercial process. © 2015 Elsevier B.V. All rights reserved.
Langer G.,NNE Pharmaplan
Pharmaceutical Engineering | Year: 2011
This article presents a three phased approach to implementing a Manufacturing Systems Solution using real life examples to demonstrate the benefits.
Fallet C.,TU Braunschweig |
Fallet C.,NNE Pharmaplan |
Rohe P.,TU Braunschweig |
Rohe P.,Jülich Research Center |
Franco-Lara E.,TU Braunschweig
Biotechnology and Bioengineering | Year: 2010
The synthesis and secretion of the industrial relevant compatible solutes ectoine and hydroxyectoine using the halophile bacterium Chromohalobacter salexigens were studied and optimized. For this purpose, a cascade of two continuously operated bioreactors was used. In the first bioreactor, cells were grown under constant hyperosmotic conditions and thermal stress driving the cells to accumulate large amounts of ectoines. To enhance the overall productivity, high cell densities up to 61 g L -1 were achieved using a cross-flow ultrafiltration connected to the first bioreactor. In the coupled second bioreactor the concentrated cell broth was subjected to an osmotic and thermal down-shock by addition of fresh distilled water. Under these conditions, the cells are forced to secrete the accumulated intracellular ectoines into the medium to avoid bursting. The cultivation conditions in the first bioreactor were optimized with respect to growth temperature and medium salinity to reach the highest synthesis (productivity); the second bioreactor was optimized using a multi-objective approach to attain maximal ectoine secretion with simultaneous minimization of cell death and product dilution caused by the osmotic and thermal down-shock. Depending on the cultivation conditions, intracellular ectoine and hydroxyectoine contents up to 540 and 400 mg per g cell dry weight, respectively, were attained. With a maximum specific growth rate of 0.3 h -1 in defined medium, productivities of approximately 2.1 g L -1 h -1 secreted ectoines in continuous operation were reached. © 2010 Wiley Periodicals, Inc.
Beregovykh V.V.,Moscow State University |
Spitskiy O.R.,NNE Pharmaplan
Vestnik Rossiiskoi Akademii Meditsinskikh Nauk | Year: 2014
Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to fullscale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factor for risk analysis having the most impact on quality attributes of a medicinal product. Further important factors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied. © 2014 Annals of the Russian academy of medical sciences.
Johnsson O.,Lund University |
Sahlin D.,Novozymes AS |
Linde J.,NNE Pharmaplan |
Liden G.,Lund University |
Hagglund T.,Lund University
Control Engineering Practice | Year: 2015
In this study a modified mid-ranging strategy is proposed where the controller for the secondary manipulated variable uses its own output as its setpoint, possibly with an offset and/or re-scaling. This modification allows the manipulated variables to increase in unison so that the mid-ranging advantage of utilizing the fast dynamics of the primary controller to regulate the process can be achieved also in non-stationary processes, while not adding complexity to the controller. The proposed control strategy has been implemented in pilot-scale (500. l) industrial bioprocesses where it is used to control the dissolved oxygen level by manipulating agitator speed and aeration rate. The controller is demonstrated to perform well in these, outperforming a reference controller which has previously been shown to give satisfactory control performance. It is also shown in similar experiments that the strategy can easily be adapted to control dissolved oxygen in bioprocesses where the feed rate is controlled using an extremum-seeking controller. The proposed strategy is generally applicable to non-stationary processes where a mid-ranging approach is suitable. © 2015 Elsevier Ltd.
PubMed | Lundbeck and NNE Pharmaplan
Type: | Journal: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences | Year: 2016
Due to the complexity and difficulties associated with the mechanistic modeling of roller compaction process for scale-up, an innovative equipment approach is to keep roll diameter fixed between scales and instead vary the roll width. Assuming a fixed gap and roll force, this approach should create similar conditions for the nip regions of the two compactor scales, and thus result in a scale-reproducible ribbon porosity. In the present work a non-destructive laser-based technique was used to measure the ribbon porosity at-line with high precision and high accuracy as confirmed by an initial comparison to a well-established volume displacement oil intrusion method. The ribbon porosity was found to be scale-independent when comparing the average porosity of a group of ribbon samples (n=12) from small-scale (Mini-Pactor) to large-scale (Macro-Pactor). A higher standard deviation of ribbons fragment porosities from the large-scale roller compactor was attributed to minor variations in powder densification across the roll width. With the intention to reproduce ribbon porosity from one scale to the other, process settings of roll force and gap size applied to the Mini-Pactor (and identified during formulation development) were therefore directly transferrable to subsequent commercial scale production on the Macro-Pactor. This creates a better link between formulation development and tech transfer and decreases the number of batches needed to establish the parameter settings of the commercial process.
News Article | February 26, 2015
Christophe Boulanger, Managing Director, NNE Pharmaplan India,in an interview with Usha Sharma, speaks about the company’s future plans for the Indian market How long you have been associated with the Indian pharma market and what have been your learning experiences? NNE Pharmaplan is a business partner to the pharmaceutical and biotech industries and is one of the leading engineering and consulting companies within the field. NNE Pharmaplan started its operations in 1996 in India and has been providing engineering consulting services to the pharma and biotech sector over the past 18 years. Personally, I have been associated with the global pharma industry for more than 20 years now. During the past eight years, I have been involved in various global positions within NNE Pharmaplan which has given me insights into the Indian pharma industry. The Indian pharma market, along with the markets of China, Brazil and Russia, will spearhead growth in the pharma industry in the coming years. The Indian market has some unique characteristics: First, branded generics dominate, making up for 70 to 80 per cent of the retail market. Second, local players have enjoyed a dominant position driven by formulation development capabilities and early investments. Third, price levels are low, driven by intense competition. However, the industry will need to strengthen three sets of commercial capabilities: marketing excellence, sales force excellence and commercial operations. In addition, players will need to put in place two enablers: strengthen the organisation to be able to sustain performance and manage rising complexity; and collaborate with stakeholders within and outside the industry to drive access and shape the market. NNE Pharmaplan is aligning itself to cater to these requirements and help the industry players to strengthen their operations by providing first-class consulting services driven by technology leadership. Tell us about the company’s ongoing activities and the major projects which it is working on? In India, we focus on vaccines, OSD and injectables as well as the latest trends and technologies such as single-use systems. To support this, we have established a consulting department focused on high-level business support, which is headed by Aeby Thomas. Aeby comes with a rich global experience in production and consulting, and has been with NNE Pharmaplan for more than seven years. Supporting him, we have local experts in India. At the same time, we are also utilising our global consulting department to look into critical domains such as containment, oncology and continuous processing. Our focus has always been to create value for our customers across the world. We strive to deliver a similar experience for our customers irrespective of where they choose to work with us. Our goal is to increase the quality of our deliveries while focusing on our core of pharma and biotech customers. We are currently engaged in the following domains in India: Unfortunately, I cannot share the precise customer and project details with you due to confidentiality agreements. There have been regulatory compliance issues with many Indian manufacturing facilities. How critical are these challenges? What steps do you follow to overcome these issues? It’s important to note that many Indian companies understand and adhere to current good manufacturing practices (cGMPs). The problems encountered by FDA investigators in India are similar to those seen around the world in manufacturing. These include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing and product adulteration or contamination. While some Indian companies operate state-of-the-art facilities and meet cGMPs, others do encounter problems and operational challenges. Not only is quality critical to public health, but also the basis of the public’s confidence in pharma. Overcoming these issues requires a willingness to change and a pro-active approach to looking into other high technology industries, investigate their practices and adopt these selectively so as to achieve the goals of transparency, traceability and therefore quality. When designing facilities, we have our GMP experts review the layout of the facility. Our GMP experts are up-to-date with latest guidelines and regulations laid down by FDA which helps us to design facilities in accordance with current guidelines. NNE Pharmaplan has devised internal tools called ‘Our model and our Wiki’ which are global platforms for sharing knowledge about latest trends and technological solutions available across the globe and for sharing best practises within the organisation. If a customer wants to check whether their facility is in compliance with latest guidelines, NNE Pharmaplan can provide GMP review and assessment studies and make a review report with recommendations of corrective actions. Why should multinational pharma companies invest in India? Particularly in the Asia-Pacific region, which market do you feel have a huge business potential and why? India is expected to rank amongst the top three pharma markets in terms of incremental growth by 2020. Within APAC, NNE Pharmaplan has offices in India, Malaysia and China and we have the required muscle to support even the biggest and most complex projects in this region. However, I still believe that India has an advantage in these markets, primarily due to the following reasons: Workforce: India possesses a skillful workforce with high managerial and technical competences. Cost-effective chemical synthesis: The track record for development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent. Legal and financial framework: India is a democratic country with a solid legal framework and strong financial markets. There is already an established international industry and business community. Globalisation: The country is committed to a free market economy and globalisation, which is constantly increasing. Approval time for new facilities has been drastically reduced. India’s cost of production is significantly lower than that of the US and almost half of that of Europe. What will the consultant keep in mind while setting up new units? NNE Pharmaplan keeps in mind the following things while designing for new facilities: How many people are associated with the group and out of them how many are technical experts? NNE Pharmaplan has a resource pool of 2,000 resources at more than 25 locations around the world. The resources are divided into two categories: operational and non-operational. The operational resources are the technical resources that are involved in designing and engineering consultancy for pharma and biotech domains. Around 80 per cent of our employees are billable/ operational. They are supported by 20 per cent non-billable/non-operational employees involved in IT, HR, sales etc. NNE Pharmaplan also has a pool of senior technology partners (STP) who are high level technical specialists within their own respective fields. We currently have STPs within vaccines, sterile and aseptic fill and finish, regulatory compliance, OSD, biopharmaceuticals, medical devices and drug delivery systems. Most of our STPs are technology leaders within their domains and work to provide innovative solutions to our customers globally. Tell us about the company’s future plans. NNE Pharmaplan has set out on a journey to build long-term relationships with strategic customers based on a role as trusted advisor. We believe that we can deliver the right solutions through deep insight and understanding of our customers’ challenges and opportunities. So to say, our New Year’s resolution is to be more focused on our key customers, understand their pains, deliver customised solutions, move towards focused pharma engineering, attract the right talent and distinguishing ourselves from other players on the market by providing high value for our customers. We are on the right path of sustainable growth and we are entering the new year with a good pipeline.