Customer Newsletter
Issue 6/07
Welcome to the NextPharma Newsletter
This month I am delighted to introduce you to Bioserv Corporation, our FDA inspected leading aseptic contract manufacturing company, based in San Diego, California, which joined the NextPharma team in July of this year. The combination of Bioserv with the complimentary capabilities of NextPharma will accelerate our global reach and provide existing Bioserv customers with additional services. These services include analytics, the capability to handle specialist products such as cytotoxics, biologics, hormones and antibiotics and access to our rapidly growing Clinical Trial Packaging unit based in Europe, which is ideally located to support the growing trend for Clinical Trials in Eastern Europe.
We are already investing in Bioserv to expand its capacity and capabilities as part of our strategic plan to develop our business in North America, where we aim to become the leading outsourcing partner across the supply chain for the ever growing biotech community. The NextPharma and Bioserv business teams are already well integrated, ensuring high service delivery standards for all of our North American customers.
The acquisition of Bioserv compliments our existing sterile product non-clinical, Phase I through III and production capabilities at our site in Braine l'Alleud, Belgium and provides a platform for developing NextPharma's product development services and contract manufacturing business in North America. We are also excited by Bioserv's controlled temperature and cold chain logistics services, which we are expanding and are investing in providing similar capabilities to support customers using our clinical trials production and packaging services in Europe.
We look forward to meeting you at AAPS in San Diego in November and I would be delighted to introduce our team and our combined NextPharma-Bioserv offering to you at the Manchester Grand Hyatt San Diego on San Diego Bay on Tuesday 13 November. Please click on the link below to register your interest.
With kind regards,
Bill Wedlake
CEO, NextPharma
Bioserv Corporation
Bioserv Corporation is a cGMP contract manufacturing organization and has been serving the pharmaceutical, biotechnology, medical device, and diagnostic industries since 1988. Bioserv cGMP manufacturing facilities located in San Diego, California meet the rigorous regulatory and quality assurance compliance requirements of the FDA and ISO. Bioserv's manufacturing faciities include certified Class 100,000 (Class 8 or Class D), Class 10,000 (Class 7 or Class C), and Class 100 (Class 5 or Class A) areas. Our class 100 filling room also has aseptic lyophilization capabilities.
Bioserv's contract manufacturing services are centred on our core competencies which include Quality Systems, flexible turn-key cGMP manufacturing processes and Customer Support. Bioserv provides aseptic and non-aseptic bulk formulation, filtration, filling, lyophilizing, finished goods assembly, packaging and controlled temperature storage services.
Bioserv's Project Management team is experienced in optimizing manufacturing timelines and schedules to assure that manufacturing operations run seamless and on time.
At Bioserv, speed does not mean we sacrifice quality. Our extensive experience in Quality Assurance, proven track record, and validated manufacturing processes, equipment and facilities not only allows us to ensure that the production process conforms to each client's specifications but also adheres to the strict guidelines of the FDA and ISO.
Bioserv offers clients turn-key, flexible manufacturing that stretches from raw material sourcing to finished product shipment. Our highly trained, customer focused personnel work closely with each client to ensure that we understand their product and manufacturing requirements.
Custom cGMP Lyophilization Services
Bioserv offers custom contract aseptic and non-aseptic lyophilization services. Our large, multi-shelf aseptic (Class 100 or Class 5 or Class A) and non-aseptic lyophilization units provide a logical transition from pilot scale to clinical trial and production quantities. In addition, Bioserv's skilled technicians understand the best way to remove water from the product to help maximize reconstitution time, minimize cycle time and promote product stability - important requirements for producing the highest quality lyophilized product. Bioserv's advanced computer controlled, fully programmable lyophilization systems are managed by rigorous calibration, maintenance and validation programs. Nitrogen, argon, or atmospheric flush and vial stoppering under full, partial, or no vacuum are available. Inert gas bleed back during the lyophilization process assures a consistent sublimation and eliminates product blow-out.
Aseptic Liquid and Powder Fills
Aseptic liquid and powder filling is another Bioserv core competency. Our skilled and highly trained technicians are capable of managing unique procedures, fill tolerances and special handling requirements during an aseptic filling project. Our validated class 10,000 (Class 7 or Class C) formulation and compounding rooms and Class 100 (Class 5 or Class A) filling areas in addition to our precision filling equipment and validated aseptic liquid filling procedures provide clients with aseptic manufacturing.
Logistics and Storage
Bioserv provides custom label printing and application, custom kit assembly, and packaging services. We can assembly kits specially configured for each application, drawing on years of experience in developing integrated and optimized package design solutions. Bioserv also offers controlled temperature and cold chain storage ranging from room temperature to -80°C. Our validated cold temperature storage areas (2° to 8°C, -15°C to -25°C, and -65°C) are monitored 24 hours a day, seven days a week to ensure that product is stored per client's requirements.
We cordially invite you to join us at the Manchester Grand Hyatt San Diego on San Diego Bay on November 13th, 2007 at 6:30 pm for hors d'oeuvres and refreshments.
Bioserv was recently acquired by NextPharma Technologies Inc ("NextPharma"). We would like to take this opportunity to introduce you to the NextPharma team with a short presentation by Bill Wedlake, President and CEO of NextPharma.
Please R.S.V.P. no later than Friday November 5, 2007. Send responses to:
Kelly Pisarev
Marketing Associate
NextPharma Technologies Inc / Bioserv Corporation
Phone: (858) 450-3123
E-mail: kelly.pisarev(at)nextpharma-us.com
We look forward to seeing you there!
Sincerely,
The NextPharma / Bioserv team
To find out more about how NextPharma and Bioserv facilitate your business needs - please contact:
Rich Masino
Bioserv Corporation
5340 Eastgate Mall
San Diego, CA 92121-2804
USA
Phone +1 858 450 3123
Fax +1 858 450 0785
Email: rich.masino(at)nextpharma-us.com
