2009 Pre-Interphex Showcase: Outsourcing & Consulting Services
Founded in 1994, QPharma has built its reputation on delivering value to the life-science and related industries through a wide range of regulatory and compliance solutions. QPharma’s suite of professional services spans the product-development life cycle, from quality and validation solutions to fulfillment services.
QPharma, Morristown, NJ
A brochure from Ben Venue Laboratories describes the company’s contract manufacturing services. Capabilities include the development and production of dosage forms such as sterile suspension, emulsion, liposome, microsphere, lyophilized, and liquid injectables in aqueous or nonaqueous solvent systems. The company produces batch sizes from clinical to commercial scale.
Ben Venue Laboratories, Bedford, OH
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
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
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
Chemistry and biology 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
Azopharma Product Development Group provides full product development and stand-alone services for the pharmaceutical, biotechnology, and medical-device industries. The company offers services from the preclinical phase to commercialization. Capabilities include full investigational-new-drug filings, new-chemical-entity filings, abbreviated new-drug-application filings, and medical-device development.
Azopharma Product Development Group, Hollywood, FL
Vetter offers a process for aseptically prefilled syringe systems. The process prefills different ingredients and solvents separately and stores them in a specially developed dual-chamber system. This procedure enables the lyophilization of substances that are unstable in liquid form. The dual-chamber system is easy for patients to use.
Vetter Pharma-Fertigung, Ravensburg, Germany
tel. +49 0 751 3700 0
Hospira One 2 One is a world leader in the custom manufacture of parenteral products 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 One2One, Lake Forest, IL
Boston Analytical expanded its laboratory space by 5000 ft2 to meet increasing demand for contract analytical and microbiological testing services. The company offers quality product release, stability, method development, and microbiological testing services in a time-efficient, personable, and affordable manner.
Boston Analytical, Salem, NH
Raw-materials testing services
Lancaster Laboratories offers comprehensive raw-materials testing with excellent scientific expertise, capabilities, and service. For harmonization with the US Pharmacopeia and European Pharmacopoeia, Lancaster Laboratories is trusted for outsourcing consolidation and consultation. The company strives to provide quality, availability, specialization, and on-time delivery. Customized services are available.
Lancaster Laboratories, Lancaster, PA
Cambridge Major Laboratories is a global, service-based chemistry-outsourcing partner to the pharmaceutical and biotechnology industries. The company provides development and large-scale manufacturing services for active ingredients. A facility in the US complies with good manufacturing practice, and the company also maintains facilities in Europe.
Cambridge Major Laboratories, Germantown, WI
Bayer has expanded its Pharmaceutical Manufacturing Services Program to better serve current and potential clients. The company’s multiuse plant is designed for flexibility and precision manufacturing of sterile injectables, nonsterile liquids, solid doses, creams, and pastes. The company meets regulatory requirements.
Bayer HealthCare, Shawnee, KS
WellSpring Pharmaceutical is a full-service provider of clinical and commercial manufacturing and packaging, blinding, method development, analytical testing, and distribution services. Highly qualified managers and technical professionals work at the company’s 100,000-ft2 facility to ensure that clients’ clinical and commercial products meet high standards.
WellSpring Pharmaceutical Canada, Oakville, Canada
and packaging services
CPC develops, manufactures, and packages premium products with a sharp focus on clients’ needs. The company manufactures solid-dose prescription pharmaceuticals, over-the-counter drugs, and dietary supplements. CPC uses state-of-the-art equipment in 175,000 ft2 of production facilities.
Contract Pharmacal, Hauppauge, NY
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 µm).
Glatt Pharmaceutical Services, Ramsey, NJ
An eight-page brochure describes Baxter’s cytotoxic manufacturing facility in Halle, Germany. It includes information about cytotoxic contract manufacturing using barrier-isolator technology and services such as lyophilization, liquid-vial filling, dry-powder filling, and sterile crystallization. The facility manufactures for distribution to markets such as the United States, Europe, and Japan.
Baxter BioPharma Solutions, Round Lake, IL
Pfizer CentreSource offers various sterile manufacturing capabilities. The company manufactures sterile suspension solutions, lyophilized products, and cytotoxic products. Development and commercial-scale production are available. Other services include stability testing, scale-up, technology transfer, process optimization, and validation.
Pfizer CentreSource (PCS), Kalamazoo, MI
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
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
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
Patheon’s services range from preclinical development through commercial manufacturing of a full array of dosage forms. Patheon uses innovative technologies, including single-use disposables, liquid-filled hard capsules, and various modified-release technologies. Its range of pharmaceutical development services includes preformulation, formulation, analytical development, clinical manufacturing, scale-up and commercialization.
Patheon, Durham, NC
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
Compliant contract services
Ash Stevens is certified as compliant with the Synthetic Organic Chemical Manufacturers Association’s ChemStewards program. This environmental, health, safety, and security program was designed specifically for the batch, custom, and specialty-chemical industries. Ash Stevens’s participation indicates a commitment to compliance with federal regulation and building cooperation throughout the supply chain.
Ash Stevens, Detroit, MI
Metrics offers potent and cytotoxic solid-oral drug development and clinical-supplies manufacturing for Phase I–III projects as large as 10 kg. The company’s dedicated facility provides total engineered containment of pharmaceutical processes through customized hard-wall isolation technologies that eliminate the need for powered air-purifying respirators.
Metrics, Greenville, NC
Surface-area and porosity system
The “Tristar II” automated, three-station, surface-area and porosity analyzer increases the speed and efficiency of quality-control analyses. The unit provides the accuracy, resolution, and data reduction to meet most research requirements. The instrument features a krypton option that enables measurements in a low surface-area range.
Micromeritics Instrument, Norcross, GA