Partners in innovation

A recent study conducted by a leading consulting firm revealed that today’s pharmaceutical manufacturers are realising far greater benefits from outsourcing than originally envisioned. While outsourcing may have gained traction as a strategy to control costs and tighten the focus on core competencies, outsourcing providers are now perceived as valued strategic partners who can also provide tighter control over important capabilities, the flexibility to meet evolving needs, and perhaps most importantly, as engines of innovation that can create value – and revenue – for the future.

In light of these findings, it is not surprising that identifying and qualifying capable outsourcing partners is a high priority for pharmaceutical manufacturers. And the best way to survey the full range of potential providers in every major category is a visit to PharmaSourcing & Services at INTERPHEX, the pharmaceutical industry’s most comprehensive outsourcing resource.

Sponsored by Contract Pharma and co-sponsored by PharmSource Information Services, Inc, the Bio/Pharmaceutical Outsourcing Report and the Pharmaceutical Outsourcing Management Association (POMA), this annual event gathers nearly 150 leading contract manufacturers and service providers under one roof at New York City’s Jacob K Javits Convention Center, where they showcase their most innovative services and capabilities.

‘PharmaSourcing & Services provides [attendees with] a unique opportunity to meet face to face with potential suppliers, gain an understanding of their processes, corporate culture and communication style, and even meet some of their current customers,’ explains John Stuttard, industry vice president of Reed Exhibitions, producer of PharmaSourcing & Services. ‘It’s a great way to gain a perspective on not only the leading players, but also innovative newcomers who may provide a service you didn’t even know you needed.’

‘I recently visited a major drug manufacturer,’ Studdard adds, ’and was fascinated to see that the warehouse function was contracted out, but to look at it, you would never have known. The staff are all equally accountable to all internal and FDA standards. The company saved a fortune.’

Exhibitor service offerings include: analytical methods and pharmaceutical systems; best practices and document development; biopharmaceutical development and scale-up; contract manufacturing; CRM; distribution; kitting; logistics; packaging; research and testing facilities; performance management; project management; sales automation; solid production; SOP and batch records development; validation support; and warehousing.

PharmaSourcing & Services attendees will have the opportunity to learn first hand about innovative new services and capabilities that can provide a significant competitive advantage. Companies highlighting exciting new offerings at this year’s event include:

Baxter BioPharma Solutions will showcase its new proprietary formulation technologies. NANOEDGE dispersion technology reduces the particle size of most drugs to nanometer size, which can enhance saturation solubility and dissolution rate while eliminating the need for undesirable co-solvents. PROMAXX microsphere technology can offer high drug loading and precise particle size control, and enable dosing flexibility across various administration routes and release profiles.

BioStorage Technologies, Inc provides state-of-the-art sample management services, including logistics and repository services for temperature sensitive biological materials, products and related data. The Intelligent Sample Inventory Storage System (ISISS™) stores samples in the most logical and efficient manner for quick and error-free retrieval when needed, and provides an advanced electronic audit trail. Clients have access to information on their samples via a secure, 128-bit encrypted internet portal.

Cardinal Health now offers scientific and regulatory consulting services through its wholly owned subsidiary Beckloff Associates. Capabilities include consulting services required to obtain marketing approval for drugs, biologics and medical devices in the US, Canadian, European and Asian markets.

Celsis Laboratory Group has expanded its cleanroom and microbial ID capabilities with the addition of a new Class 100 cleanroom and MIDI Sherlock Microbial Identification System at its New Jersey facility. These services had previously been available only through another US facility in St Louis.

Chesapeake Biological Laboratories, Inc’s new Accelerated Clinical Trial Materials (ACTM) programme dramatically reduces the amount of time required to get released product for clinical trials. The programme enables clients to have their vials filled, batch record released and product shipped to the clinical trial location within 120 days.

Glatt Pharmaceutical Services is featuring two new proprietary controlled release drug delivery technologies for both ANDA and NDA products: CPS Technology™ – Controlled Release Pellet System and ZRx™ Technology – Zero-Order Release Tablet System. These technologies are offered to the pharmaceutical industry through product specific licensing agreements and joint development collaborations.

Lancaster Laboratories, Inc will feature its expanded biopharmaceutical testing services, including more large molecule support. The company has formed a new group to provide a wider range of services in the biochemical, molecular and microbiology areas.

Cleanroom wiper manufacturer Lym-Tech Scientific is announcing the opening of its European warehouse in Ghent in Belgium. The new warehouse’s central location enables distributors to receive wiper shipments in days instead of weeks. With prepaid duties, Lym-Tech further reduces time and paperwork and allows distributors to focus on growing sales.

Mallinckrodt Pharmaceuticals Outsourcing has added barcoded unit dose packaging to its list of capabilities. The company’s new unit dose packaging line produces blister cards that are barcoded to the unit of use. Barcoding allows healthcare providers to scan product information easily, which enables better inventory management and minimises administrative errors.

Metrics, Inc will announce expanded formulation development capabilities. The company has added new personnel and expanded its facilities to offer additional capacity and expertise in formulation for sustained release, soft coating, encapsulation and bead coating, as well as potent and controlled substance development.

Anticon^®; by Milliken will feature the Captura™ family of non-woven wipers, constructed from a proprietary rayon and producing a fabric that combines cleanliness with sorbency. Sterilisation is available, as well as presaturation with various cleaning solutions.

Prudential Cleanroom Services will feature its new sterile goggle programme, which provides re-usable, gamma-irradiated goggles for pharmaceutical and biotech workers in critical environments. The new programme enables significant savings and reduced environmental impact. In addition, the company will announce its expanded inventory and logistics system, providing the capability to extend services to Puerto Rico.

A framework for more productive partnerships

For fresh perspectives on outsourcing issues and trends, the PharmaSourcing Conference provides an entire day of authoritative insight and best practices. Opening with a state of the industry general session by Jim Miller, founder and president of PharmSource Information Services, the programme features a variety of high-interest sessions, led by respected outsourcing experts who will share insights and expertise gained from years of real-world experience. Seminar topics include:

• Managing Risk in the Outsourced Environment
• Managing Pharmaceutical Supplier Relationships
• Strategic Partnerships with API Suppliers
• Outsourcing to India
• Outsourced Packaging in the Digital Age
• Outsourcing Success: Critical Factors Affecting Success in Major Outsourcing Agreements
• Strategic Partnerships with API Suppliers
• In addition, this year’s programme offers three accredited workshops presented by the Center for Professional Advancement:
• GMPs for Excipients – Compliance Issues
• Outsourcing, Selecting & Managing Contract Research Organisations
• The Legal & Regulatory Aspects of Pharmaceutical Sourcing – What Are Your Rights and Responsibilities?

PharmaSourcing & Services at INTERPHEX

PharmaSourcing & Services is part of INTERPHEX, one of the most trusted sources for leading-edge insight into issues, education, and sourcing of the products and services that drive innovation in pharmaceutical manufacturing. The event’s unique combination of advanced technologies from virtually all of the industry’s leading suppliers and cutting-edge education makes it a focal point for understanding the changing dynamics and latest technologies required for success.

INTERPHEX2005 will take place on 26–28 April 2005 at the Jacob K Javits Convention Center in New York City. For complete event details, an up-to-date exhibitor list, including a searchable database with product information and links to exhibitor websites, and convenient online registration, visit www.interphex.com/pharmasourcing.