Pre-Interphex Showcase: Outsourcing

March 1, 2008

Pre-Interphex Showcase: Outsourcing

Containment capabilities
Lyophilization Technology has on-site containment capabilities for highly potent compounds, oncology therapeutics, and biologicals. The company’s qualified facility features negative-pressure isolators for primary containment within an ISO 7 room and ISO 5 processing areas. The company seeks to safeguard products' integrity and provide high quality.

Lyophilization Technology, Ivyland, PA
www.lyotechnology.com
tel. 215.396.8373

Cytotoxic contract manufacturing
An eight-page brochure describes Baxter’s cytotoxic manufacturing facility in Halle, Germany. It
includes information about cytotoxic contract manufacturing using barrier-isolator technology as well as services such as lyophilization, liquid vial filling, dry-powder filling, and sterile crystallization. The facility manufactures for distribution to global markets, including the United States, Europe, and Japan.

Baxter BioPharma Solutions, Round Lake, IL
www.baxterbiopharmasolutions.com
tel. 800.422.9837

Contract services
Catalent Pharma Solutions, formerly Cardinal Health Pharmaceutical Technologies and Services, assists pharmaceutical and biotechnology companies with their global development, drug delivery, manufacturing, and packaging needs. Catalent’s global facility network helps clients overcome formulation hurdles, achieve approval milestones, and meet market needs effectively.

Catalent Pharma Solutions, Somerset, NJ
www.catalent.com
tel. 866.720.3148

Parenteralproducts
Hospira One 2 One is a world leader in the custom manufacture of parenteral pro-ducts offering vials, flexible containers, cartridges, prefilled syringes, and ampules. Hospira’s expertise comes from 70 years of quality manufacturing. One 2 One has been a reliable outsourcing partner to some of the world’s largest pharmaceutical and biotechnology companies.

Hospira One 2 One, Lake Forest, IL
www.hospira.com
tel. 224.212.2267

Contract services
SGS Life Science Services provides clinical research services and quality-control testing. SGS provides clinical-trial management (Phase I to IV) and services encompassing bioequivalence studies, bioanalytical services, data management, biometrics, and regulatory consultancy. Quality-control services include analytical chemistry, microbiology, and toxicology tests that meet regulatory compliance.

SGS Life Science Services, Fairfield, NJ
www.sgs.com/lifescience
tel. 866.SGS.5003

Coating services
The Chemsultants International Product and Process Development Center provides a full range of coating services, including pilot coating, toll coating, and small-scale manufacturing. The company specializes in applying adhesives and specialty coatings to narrow webs of paper, film, foil, and other synthetic materials.

Chemsultants International, Mentor, OH
www.chemsultants.com
tel. 440.974.3080

Custom fermentation services
Pfizer CentreSource offers customized fermentation capabilities. The company works with various organisms to yield an array of product types. The company provides containment-level capabilities and expertise in culture improvement, fermentation-process optimization, and recovery improvement. Pfizer also offers postfermentation chemical processing, including advanced synthetic technologies.

Pfizer CentreSource (PCS), Kalamazoo, MI
www.pfizercentresource.com
tel. 269.833.5844

Chemistry andbiology services
Ricerca provides the pharmaceutical
and biotechnology
industries with
preclinical chemistry and biology services. The company’s process-chemistry group and pilot plant make drug-candidate active pharmaceutical ingredients (APIs) scaleable for Phase I–III. Ricerca also provides niche, commercial-scale APIs. Manufacturing is supported by analytical services to ensure the safety and quality of the materials used.

Ricerca Biosciences, Concord, OH
www.ricerca.com
tel. 888.742.3722

Pharmaceutical development
Azopharma is a contract pharmaceutical development organization that provides a range of chemistry, manufacturing, and controls solutions for the pharmaceutical industry. Azopharma has experience in formulations, custom synthesis, isolation, purification, elucidation, characterization, method development, and validation and clinical supplies for Phase I trials.

Azopharma, Miramar, FL
www.azopharma.com
tel. 954.433.7480

Pharmaceuticalservices
DSM Pharmaceuticals offers contract manufacturing and development services. Capabilities include the manufacture and development of sterile liquids and lyophi-lized products to solid, semisolid, and liquid dosage forms. The company provides assistance with formulation and development, production scale-up, regulatory consultation, secondary manufacturing, and primary and secondary packaging.

DSM Pharmaceuticals, Parsippany, NJ
www.dsmpharmaceuticals.com
tel. 973.257.8011

Contract manufacturing services
Lyne Laboratories provides pharmaceutical manufacturing services for dosage forms, including high-alcohol content or solvent-based drug products. An explosion-proof facility is available for high-concentration flammable products. Lyne also manufactures liquids, syrups, suspensions, semisolids, tablets, powders, and dropper bottles. Other services include technical transfer, analytical and validation services, stability programs, and regulatory support.

Lyne Laboratories, Brockton, MA
www.lyne.com
tel. 800.525.0450

Contract services
Mikart offers contract
development and manufacturing services from scale-up through full-scale commercial production. Mikart's 40,000-ft2 science center includes analytical laboratories, quality control, and a complete pilot-scale manufacturing suite. Services include preformulation and product approval as well as fluid-bed granulation, roller compacting, and film coating technologies.

Mikart, Atlanta, GA
www.mikart.com
tel. 888.4MIKART

Contract manufacturing
Covidien manufactures high-quality solid-dose and oral liquid finished dosage products from active-ingredient production to commercial launch. Capabilities include immediate- and extended-release tablets, hard-shell capsules, powder- and liquid-filled capsules, overencapsulation, and oral nonsterile liquids.

Covidien Pharmaceuticals Outsourcing, Hobart, NY
www.pharmaceuticals.mallinckrodt.com/outsourcing
tel. 607.538.2065

Contract services
Akorn specializes in the development and commercial manufacture of sterile liquid, parenteral, ophthalmic, lyophilized parenteral, and ointment dosage forms. The company provides services from formulation development to commercial manufacturing. Akorn produces high-quality products at three state-of-the-art manufacturing facilities.

Akorn, Buffalo Grove, IL
www.akorn.com
tel. 847.279.6179

Global clinical supplies
Bilcare provides the Americas, Europe, and Asia with clinical-trial materials (CTM) support, services, and project management. Services for solid, semisolid, liquid, and biotechnology CTM satisfy requirements for preformulation research and development, analytical services and clinical supplies packaging and labeling, controlled-temperature storage, and distribution.

Bilcare Global Clinical Supplies, Phoenixville, PA
www.BilcareGCS.com
tel. 800.310.4445

Effervescent-product services
Amerilab Technologies develops, manufactures, and packages effervescent tablets and powders. The company has developed and produced hundreds of effervescent formulas. Amerilab has the experience and the personnel to successfully manage new-product or line-extension development, scale-up, production, and packaging.

Amerilab Technologies, Plymouth, MN
www.amerilabtech.com
tel. 763.525.1262

Contract chemistry services
Chemic Laboratories serves the pharmaceutical, biotechnology, and specialty-chemicals industries. Chemic provides methods development, validation, extractables and leachables analysis, container-closure assessment, bioanalytical services, organic synthesis, formulation development, and stability programs. Chemic manufactures high-purity excipients through proprietary methodology.

Chemic Laboratories, Canton, MA
www.chemiclabs.com
tel. 781.821.5600

Clinical-supply services
Fisher Clinical provides global clinical-supply services. The company continues to expand its capabilities with strategically located facilities to provide accurate and cost-effective solutions for global clinical trials. Services include analytical chemistry, drug overencapsulation, packaging, clinical labels, storage, global logistics, and ancillary supply services.

Fisher Clinical Services, Allentown, PA
www.fisherclinicalservices.com
tel. 610.391.0800

Contract biomanufacturing services
Cook Pharmica provides CGMP manufacturing for cell culture-based biopharmaceuticals as well as CGMP cell banking and cell bank storage. Cook also offers development services for mammalian and microbial systems, including cell-line and strain development, media optimization, molecular biology, scale-up and process development, purification development, and analytical testing.

Cook Pharmica, Bloomington, IN
www.cookpharmica.com
tel. 877.312.2665

Contract pharmaceutical services
Capsugel is a leading supplier of two-piece capsules. The company has more than 140 years of experience and offers formulation services, multiple polymers, patented dosage-delivery technology, and liquid and precision powder-filling equipment.

Capsugel, Peapack, NJ
www.capsugel.com
tel. 908.901.8000

Contract services
Powdersize offers a contract facility compliant with current good manufacturing practices for the micronizing, micropulverizing, and classification of dry powders. The company processes batch sizes from grams to metric tons and provides scale-up services. Powdersize’s milling technologies include vertical or horizontal jet mills, fitz mills, and pin mills.

Powdersize, Quakertown, PA
www.powdersize.com
tel. 215.536.5605

Manufacturing and testing services
Talecris (formerly Precision Pharma Services) offers contract manufacturing and testing services at its Melville, New York, facility. Services include clinical, small-scale, and commercial-stage products. Talecris specializes in sterile pharmaceutical, biopharmaceutical and complex biological finished products. The company offers reliability and a record of regulatory compliance.

Talecris Biotherapeutics, Melville, NY
www.talecris.com
tel. 631.752.7314

Contract services
UPM Pharmaceuticals is a drug-development and contract-manufacturing company that provides formulation development, manufacturing, and analytical services. UPM's scientists have industry experience in oral solid and liquid dosage forms from feasibility and Phases I–III to commercial products. The company’s services are characterized by responsiveness and timely communications and are customized to clients' drug-development programs.

UPM Pharmaceuticals, Baltimore, MD
www.upm-inc.com
tel. 410.843.3700

Contract services
Metrics, Inc. is a pharmaceutical development and contract analytical laboratory with more than 170 scientists and support staff. The company provides a range of services in support of pharmaceutical development: formulation development, clinical trial materials, method development and validation, raw material testing, trace metals analysis and stability services.

Metrics, Inc., Greenville, NC
www.metricsinc.com
tel. 252.752.3800

Particle design
Hovione offers a brochure that describes its particle design technology and CGMP-compliant spray drying facilities, which have been designed to build on the company's expertise in all major areas of API development. Particle design technologies include controlled crystallization, micronization by jet-milling, freeze drying, and freeze fracturing. Analytical support includes Malvern, DSC, infrared, and NMR.

Hovione, Sete Casas, Portugal
www.hovione.com
tel. 1351 21 982 9245

Pelletization technology
Glatt offers its CPS technology for direct pelletization of active pharmaceutical ingredients with either immediate- or modified-release properties. It can produce dense, spherical, and uniform pellets with a high concentration of drug active (.90%) or with uniformly distributed low-dose actives within a narrow particle-size distribution over a range of median particle sizes (. 100 mm).

Glatt Contract Pharma Services, Ramsey, NJ
www.glattair.com
tel. 201.825.8700

Capsule-filling capability
Xcelience has purchased Capsugel's "Xcelodose 600 S" precision powder microdoser and automated encapsulator. This next-generation system fills at speeds as high as 600 capsules/h. The unit expands the company's early drug-development capabilities and supplements the current Xcelodose 600 capabilities.

Xcelience, Tampa, FL
www.xcelience.com
tel. 813.286.0404

Disposable technologies
Patheon provides integrated disposable technologies to solve sterile-manufacturing challenges. Using disposables for all product-
contact parts eliminates the need for cleaning validations and overcomes products’ incompatibility with stainless steel. Patheon applies disposable technologies to develop and manufacture various small- and large-molecule sterile products.
Patheon, Mississauga, Canada
www.patheon.com
tel. 888.PATHEON

Online data access
The "LabAccess" web portal from Lancaster Laboratories offers pharmaceutical clients a secure online window to updated analytical information about their projects. The portal allows clients to view information such as analysts' notebooks, chromatograms, approved test results, certificates of analysis, raw data packages, and invoices.

Lancaster Laboratories, Lancaster, PA
www.lancasterlabs.com
tel. 717.656.2300

Consultingservices
Sterigenics offers "SteriPro Consulting" for startup firms and major multinational pharmaceutical manufacturers. The company is a resource for assistance with all aspects of product sterilization. Sterigenics's consultants help clients develop effective solutions for their products.

Sterigenics International, Oak Brook, IL
www.sterigenics.com
tel. 800.472.4508

Contract services
Aptuit provides consulting expertise, facilities that comply with good manufacturing practices, technologies designed to expedite the development process, project-management capabilities, and regulatory-compliance services. Aptuit also offers a package for strategic and regulatory consulting, informatics, preclinical and clinical technologies, pharmaceutical sciences, clinical packaging and logistics, and active pharmaceutical ingredient development and manufacture.

Aptuit, Greenwich, CT
www.aptuit.com
tel. 816.767.3900