CPhI Newsletter
Issue 5/11 NextPharma at CPhI 2011
Welcome to the NextPharma CPhI Newsletter
As always we look forward to meeting you in person at our stand throughout CPhI to discuss your outsourcing requirements in detail.
At CPhI this year we’d like to introduce you to our new CEO, Franck Latrille, who has recently joined NextPharma with a broad and deep experience of the global pharmaceutical industry, having most recently held executive board positions at Merck-Serono SA, including Deputy CEO and EVP Marketing and Sales. Previously at Serono SA he held executive board positions with responsibility for pharmaceutical manufacturing and product development operations. He also holds a PhD in biochemistry and physiology. Franck will be on the stand throughout CPhI and looks forward to meeting you all in person.
We’d welcome the opportunity to update you on other changes we’ve made since last year including:
1 - Our new ‘state of the art’ Cold Chain and Logistics (CLS) warehouse in Werne, Germany which is now fully operational and we’re in the final stages of preparing for its official inauguration which will take place on 18th November this year.
The new facility is strategically located 3 km away from the A1 motorway in western Germany, between Münster and Dortmund. It has 15,800m² of warehouse and 1,000m² of office space. It has the capacity to house up to 26,000 euro-pallets, starting with an initial 19,000 euro-pallets and currently employs 40 employees.
Additionally, it has modern temperature monitoring (under floor heating, hot-air blowers and air conditioning). The building, as well as meeting pharmaceutical service provider requirements, consists of 2 fire sections, 7 conventional docks, 1 jumbo dock and 1 insulated dock. It has wholesaler authorization (§52a AMG) and will achieve a manufacturing license (§13 AMG) for manual re-packaging, bundling and labelling of secondary packaging early next year.
2 - Our Clinical Trials Services (CTS) facility in Göttingen, Germany has been enhanced through the installation of a ModuC LS IPC encapsulation/over-encapsulation capsule filling machine. The new machine is fully automated and capable of filling and over-encapsulating a wide range of solid and liquid products.
Dependent upon demand, further filling stations can be added. The filling stations can be operated individually or in combination enabling a wide range of filling possibilities. As a result of this flexibility NextPharma can efficiently and cost-effectively encapsulate and over-encapsulate investigational medicinal products with a speed of up to 20,000 units per hour. The machine also has the additional security of having 100% online weight control of each capsule.
3 - At our Waltrop site in Germany following on from the expansion of our capabilities through the addition of a new hormone semi-solids area which houses a new Becomix RW 1200 CD processing mixer with a 1,200 litre production vessel – we are pleased to announce that we are implementing a capacity enlargement for bulk manufacture through the installation of a Becomix LVM 4.000 processing machine. This new high performance line operates with all types of bottles and closures/spray pump.
Finally, we’d be delighted if you’d join us at our booth (no. 42F52, Hall 4.2) on Tuesday 25th October or Wednesday 26th October from 16.30 to take part in our traditional NextPharma wine tasting and networking event and enjoy some excellent vintages with some great conversation. Remember to drop your business card in our ‘tombola’ to enter our prize draw to win a ‘Kindle’.
We wish you a safe journey to Frankfurt and remain at your service as your outsourcing partner of choice.
Best regards
Your NextPharma Team
For product development, clinical trial supplies, contract manufacturing, cold chain and logistics services, partner with NextPharma – Next Generation Pharma Solutions
Across NextPharma
Germany
Bielefeld is dedicated to the production and further processing of pellets and offers two pelleting technologies reknown for robustness and reproducibility: pelleting via extrusion or via layering of non-pareils. Compared to non-pareils the pelleting via extrusion allows more compact high density pellets, resulting in highest API contents. Consequently, smaller capsule sizes are available with the same API dose.
Berlin manufactures products containing penicillins and combined products with clavulanic acid and provides product development services for these products. This plant accommodates both production and packaging of all common solid dosage forms such as blisters, sachets and bottles. It can also provide warehousing.
Göttingen has two separate production sites - one manufacturing producing various cephalosporin forms and the other a wide range of solid dosage forms. Following its complete refurbishment in 2007 the solid dosage form site is now a centre of excellence for the production and packaging of all conventional solid dosage forms. NextPharma offers conventional tablets, hard gelatine capsules, effervescent tablets, sachets as well as alu-alu blistering. Both plants have their own separate warehouse and benefit from our onsite microbiology laboratory and analytics services.
Waltrop is FDA inspected and has extensive know how in contract manufacturing, packaging and quality control of conventional dosage forms (liquids and semi-solids). We have specific expertise and know how in the manufacture and packaging of oral contraceptives in completely separate and dedicated facilities. In addition to semi-solids with conventional APIs, NextPharma Waltrop also provides a dedicated area for manufacture and packaging of semi-solids with hormonal APIs. As an extra resource to Bielefeld – Waltrop can offer film coating of pellets.
France
Limay benefits from its ability to produce batch sizes up to 10,000 litres in liquids products such as solutions, syrups and suspensions (bottles, drops, spray, ampoules, sachets), semi-solids such as suppositories, creams and ointments (sachets, suppositories) and capsules. The plant also has a fully automated high rack warehouse.
Belgium
Braine l‘Alleud has extensive know how in contract manufacturing, lyophilization, packaging and control of cytotoxic products gained over more than 15 years and is FDA approved.
USA
San Diego, California, serves small to large corporations world wide in the biotechnology, pharmaceutical, diagnostic and medical device industries. Its aseptic area has multiple clean room suites offering Class 10,000 (Class 7 or Class C) formulation rooms and Class 100 (Class 5 or Class A) filling hoods or rooms. This facility is FDA licensed for drugs and medical devices and ISO 13485:2003 certified for medical device manufacturing.
NextPharma offers a wide range of Product Development Services (PDS) - starting with pre-formulation evaluation and formulation development work, and scale-up and production of clinical trial material for Phases I-III including process validation. In keeping with NextPharma‘s full service approach it is also possible to access our regulatory services, which can coordinate the compilation of CMC for EU authorities and also can support your submission of INDs, NDAs and ANDAs to the FDA. For customers searching for opportunities to extend their product portfolio NextPharma is developing and licensing out its own dossiers.
NextPharma provides Clinical Trial Services (CTS) including formulation development manufacturing of IMP‘s, packaging design, comparator procurement, blinding, primary and secondary packaging, analytics, stability testing, and microbiology testing. Our services are supported by a Qualified Person and experts in regulatory affairs and medical product dossiers.
NextPharma's Coldchain and Logistics Services (CLS) are supported by state-of-the-art technology appropriate for the pharmaceutical industry. Whether your product requires controlled room temperature storage or down to minus 179°C, NextPharma has the capabilities to meet your needs. NextPharma's pick, pack and ship systems ensure the right product reaches its destination according to you and your customers‘ requirements. NextPharma offers one-stop logistics solutions tailored to meet the needs of the global pharmaceutical industry under the rigid standards of cGSP / GDP regulations. This pre-wholesaling business delivers directly to pharmacies, hospitals, doctors, medical representatives, wholesalers, veterinaries, sales representatives and private recipients. Customers also benefit from NextPharma‘s economies of scale.
Full Service Approach
At NextPharma your project, whether new business or a product transfer, will be assigned a dedicated and specially trained Project Manager who will be responsible for managing your project from inception to completion ensuring that critical time lines and costs are met, technical formulation and production issues are resolved quickly and efficiently and relevant regulatory requirements are met in full.
NextPharma is uniquely qualified to be your global manufacturing partner as we develop, manufacture, package and distribute a broad range of products and formulations for our customers from tablets and capsules to antibiotics, hormones and controlled release medicines. We have an established leadership position in the high technology area of injectables manufacturing, with particular expertise in product development and manufacture of oncology medicines.