Exhibitors List

2019 PDA Cell and Gene Therapy Conference

• Biovigilant (a division of Azbil North America, Inc.) - Table 15

  2005 West Ruthrauff, Suite 151, Tucson, AZ 85705
  Tel: +1 (520) 292-2342
  Website: www.biovigilant.com

  Azbil BioVigilant Instantaneous Microbial Detection instruments provide continuous, real-time results for environmental monitoring of air and water. IMD® instruments detect particle size, count, and biological status…simultaneously. No staining, no reagents, no growth required. Visit with us to learn more about protecting your bottom line from the disastrous effects of microbial contamination.

• groninger USA LLC - Table 7

  14045 South Lakes Dr., Charlotte, NC 28273
  Tel: +1 (704) 295-9000 | Fax: +1 (704) 295-9020
  Website: www.groningerusa.com

  groninger designs and manufactures  fill/finish processing lines for pharmaceutical, consumer healthcare and cosmetic industries.  Our core competency is the design and manufacture of customized, turnkey aseptic liquid fill/finish lines which include; cleaning, sterilization, filling and closing of vials, eye drops, syringes, cartridges and combination devices.  All services provided are turnkey.

• Texcell - North America Inc. - Table 3

  4991 New Design Road, Suite 100
  Frederick, MD 21703
  Tel: +1 (301) 363-5600 Fax: +1 (301) 363-8064
  Website: www.texcell.com

  Texcell-North America, Inc. is a global contract research organization based in the Maryland/Virginia biotech corridor that specializes in custom cell culture, virus propagation/concentration, viral clearance, viral safety testing, and immunology services performed in support of biopharmaceutical regulatory applications submitted to the FDA and other regulatory authorities.

• Boston Analytical - Table 10

  14 Manor Pkwy., Salem, NH 03079
  Tel: +1 (603) 893-3758
  Website: www.bostonanalytical.com

  Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/ IEC-17025:2005 accredited pharmaceutical testing laboratory. Boston Analytical provides analytical and microbiological testing services to the pharmaceutical and medical device industries, including environmental monitoring services, sterility testing, microbial identification and enumeration, stability testing and ICHcompliant storage, and extractables and leachables studies.

• Robert Bosch Packaging Technology, Inc. - Table 6

  8700 Wyoming Ave. N., Brooklyn Park, MN 55445
  Tel: +1 (763) 493-6700 | Fax: +1 (763) 493-6776
  Website: www.boschpackaging.com

  Bosch Packaging Technology is the leader in pharmaceutical processing, packaging, and inspection systems for the pharmaceutical manufacturing industry. Our expansive portfolio of solutions provides our customers with a single source supplier for their projects and is backed with world class service. The Bosch group offers the highest quality and reliable technologies.

• Sartorius Stedim Biotech GmbH - Table 19

  August-Spindler-Str. 11, Goettingen 37079 Germany
  Tel: +1 (800) 368-7178 | Fax: +1 (631) 254-4253
  Website: www.sartorius.com

  Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves.

• West Pharmaceutical Services, Inc. - Table 2

  530 Herman O. West Dr., Exton, PA 19341
  Tel: +1 (610) 594-2800 l Fax: +1 (610) 594-2900
  Website: www.westpharma.com

  West works side by side with healthcare partners from concept to patient, designing and manufacturing packaging, diagnostic, and delivery systems that promote efficiency, reliability, and safety. West leads the way with cutting-edge technologies and quality systems, a thorough understanding of regulatory compliance, and an unmatched knowledge of pharmaceutical product testing, development, and packaging.

• MilliporeSigma - Table 8

  80 Ashby Rd., Bedford, MA 01730
  Tel: +1 (978) 715-1483
  Website: www.emdmillipore.com

  MilliporeSigma, a life science leader, is a business of Merck KGaA, Darmstadt, Germany. We supply products and services to develop and manufacture biopharmaceutical drugs safely and efficiently. Our portfolio includes fully integrated solutions and an attractive range of biopharmaceutical services from preclinical through commercial production along with regulatory services.

• Quality Executive Partners (Virtuosi®) - Table 14

  850 Ralph McGill Blvd., Unit 22, Atlanta GA 30306
  Tel: +1 (216) 538-6001
  Website: www.virtuosivr.com

  Quality Executive Partners (QxP) is a globally recognized management-consulting firm of leading technical experts and quality executives with extensive successful outcomes for companies in cell, gene, and tissue therapies. QxP’s educational platform, Virtuosi®, utilizes technical courses and interactive VR experiences to teach “How” and “Why” we perform aseptic technique and behaviors.

• Charles River - Table 20

  251 Ballardvale St., Wilmington, MA 01887
  Tel: +1 (781) 222-6000
  Website: www.criver.com

  As the partner of choice for managing microbial quality control, the Charles River purposely built Microbial Solutions portfolio of Endosafe endotoxin testing, Accugenix microbial identification, and Celsis® microbial detection solutions provides clients with the critical, decision-driving data necessary to help bring products to market safely and efficiently.

• BioMérieux Inc. - Table 1

  595 Anglum Rd., Hazelwood, MO, 63042
  Tel: +1 (314) 731-8500
  Website: www.biomerieux-usa.com

  We’re making endotoxin testing faster, easier, and ecologically friendly: With our ENDONEXT® assays and ENDOXPERTS® services, we accelerate innovation together with our Hyglos team. At this year’s PDA Annual Meeting, we are glad to introduce ENDOZYME® II GO – a new rFC assay providing great results with much less handling.

   

• BioAnalytix - Table 12

  790 Memorial Drive, Cambridge MA 02139
  Website: www.bioanalytixinc.com

  BioAnalytix works with leading biotherapeutic companies to deliver advanced analytics including precise LC-MS data packages for specific project needs through all stages of biologic drug development. Our deep understanding of CMC and regulatory requirements is leveraged to further support product development from IND through BLA submission and review.

• PSC Biotech Corporation - Table 18

  700 Corporate Center Dr., Pomona, CA 91768
  Tel: +1 (909) 784-3350 | Fax: +1 (909) 784-3354
  Website: www.biotech.com

  The PSC Biotech Hardware and Equipment Business Unit distributes equipment used in the pharmaceutical, medical device, biotechnology, and diagnostics industries. PSC Biotech Corporation is a global organization providing life science services and solutions through our professional service consultancy (PSC Biotech for commissioning, qualification, validation, and IT services), AuditUtopia™ and ACE (PSC Software inspection/audit management and eQMS), equipment distribution (Lives International data loggers and thermal mapping systems), and contract manufacturing (BioTechnique).

• Asahi Kasei Bioprocess America, Inc. - Table 4

  1855 Elmdale Avenue, Glenview, IL 60026
  tel: +1 (847) 556-9700
  website: www.ak-bio.com

  Led by Planova™ and Planova™ BioEX virus removal filters, Asahi Kasei Bioprocess America, Inc. provides consumables and equipment designed to accelerate downstream processing, improve product yields and uncover manufacturing efficiencies. Additional offerings include award-winning IBD™ Inline Buffer Dilution Systems, chromatography systems and columns plus Planova™ Virus Filtration Systems.

• Werum IT Solutions America, Inc. - Table 11

  5 Sylvan Wy., 2nd Floor, Parsippany, NJ 07054
  Tel: +1 (973) 644-4000 | Fax: +1 (973) 644-4600
  Website: www.werum-america.com

  Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Our out-of-the-box PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies.  Our solutions help pharma manufacturers to increase efficiency, improve productivity, and meet regulatory requirements. The range of projects includes global MES programs with multi-site rollouts all over the world as well as single-site solutions in individual countries. Werum’s PAS-X MES is also ideally suited to target the key challenges for Cell & Gene therapy manufacturers.

• Avid Bio Bioservices, Inc. - Table 16

  2642 Michlle Dr., Suite 200
  Tustin, CA 92780
  Tel: +1 (714) 508-6100
  Website: www.avidbio.com

  Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focusing on biologics derived from cell culture systems. A globally compliant partner of the biotechnology and biopharmaceutical industries, Avid offers a comprehensive range of process and analytical development and high-quality cGMP clinical and commercial manufacturing services

• BioSpherix Medical - Table 17

  25 Union Street, Parish, NY 13131
  Tel: +1 (315) 625-8025
  Website: www.biospherixmedical.com  

  The BioSpherix GMP-based platform offers the most efficient aseptic space fully optimized for optimal cell growth. Our closed customized technology is modular and agnostic to any equipment and any process - from manual to automated. Ideal for both small and large production processes.  In addition, our unique quality by design (QbD) approach protects both the operator and the product.

• ValSource LLC - Table 21

  918A Horseshoe Pike, Downingtown, PA 19335
  Tel: +1 (610) 269-2808 l Fax: +1 (610) 269-4069
  Website: www.valsource.com  

  ValSource is a consulting firm, tailoring quality system solutions for personalized medicine product realization, providing resources and processes for:

  • Validation, commissioning, qualification
  • Quality Risk Management
  • Compliance
  • Training
  • Facility design review

  In addition, ValSource provides a full range of program management services including knowledge management, technical resources, safety solutions, and procurement.

   

• ViruSure - Table 5

  Donau-City-Straße 1, A-1220 Vienna,
  Austria
  Tel: +43-(0)1-2699120 | Fax: +43-(0)1-2699120/22
  Website: www.virusure.com

  ViruSure is a privately-owned biotech company specializing in the virus and prion safety testing of biopharmaceutical products. We offer contract testing services and a wealth and breadth of expertise to ensure you meet all relevant pathogen safety testing requirements. Each biopharmaceutical product is unique and presents its own challenges with regards to potential viruses that might be present as contaminants. Our goal is to ensure that the strategy we develop with you will provide a high chance of success in satisfying all regulatory requirements at the first attempt.