Platinum Sponsors

dpt

emergent

fed

Renaissance Logo_2019

Silver Sponsors

Chemic

Exelead

PharmaPackSol

SGS

Gold Sponsors

abbvie

alcami

Advanced Analytical

catalent2

USA LOGO with out Name[1]

cpl

Grand River

jhs

Lonza

Tedor Pharma

Bronze Sponsors

Coatings Place

Element

Frontage

groupeparima

ILC Dover

mikart

PCI_Icons_logo

Selkirk Pharma

Wavelength

2019 Sponsors

Platinum Sponsors

DPT
DPT, a Mylan company, is a leading contract development and manufacturing organization, recognized for its excellence in semi-solid and liquid dosage forms.  DPT has unmatched experience, resources and capacity to efficiently serve your pharmaceutical development and manufacturing needs – no matter the scope.

318 McCullough
San Antonio,TX 78215
Phone: 1-866-CALL-DPT
www.dptlabs.com


Emergent

Emergent BioSolutions provides contract manufacturing services for both bulk drug substances and sterile injectable drug products. Our state-of-the-art, single-use BDS facility enables turnkey upstream and downstream support for microbial, mammalian, and viral cell lines. Our Fill/Finish services include vials and syringes for both liquid and lyophilized products. We also offer lyo cycle development and optimization. Our global manufacturing network currently produces over 30 commercial products and supports a host of clinical stage programs.

400 Professional Drive, Suite 400

Gaithersburg, MD 20879

Tel: 800-441-4225

www.ebsi.com/CMO
E-mail: CMO@ebsi.com


Federal Equipment Company
Federal Equipment Company offers 60 years of expertise buying and selling pharmaceutical processing and packaging equipment. We optimize the value you recoup for surplus equipment, while making the removal process easy. And we ensure you get the equipment you need quickly when sourced from our broad, on-hand inventory of reliable used machines.

8200 Bessemer Ave
Cleveland, OH 44127
Tel: 216-271-3500
Toll free: 800-652-2466
Fax: 216-271-5210
www.fedequip.com

Renaissance                                          
Renaissance_2019_gold Renaissance is a leading Nasal Spray and Sterile Solutions contract development and manufacturing organization located in Lakewood, NJ. With state-of-the-art laboratories, almost 20 years in nasal experience and successful commercialization of products for the US and European markets, Renaissance is the “one-stop shop” for all your nasal spray formulation, development, testing, and commercialization needs. Our capabilities cover both development and commercial scale manufacture of unit dose, bi-dose and multi-dose nasal sprays in environmentally controlled production facilities. We also have expertise in sterile ointments, small volume parenterals, and ophthalmic products.With an excellent history of regulatory approvals, we are able to onboard projects at any stage of their life-cycle – from initial concept, through formulation development/optimization and clinical manufacture, to the transfer of existing commercial products.

1200 Paco Way
Lakewood, NJ 08701
Tel: 732-367-9000
www.renpharm.com


Gold Sponsors

AbbVie Contract Manufacturing
AbbVie Contract Manufacturing has been serving our partners for more than 35 years across ten of our manufacturing facilities located in both North America and Europe. Our contract development and manufacturing capabilities span both small and large molecule API including classical fermentation, chemical synthesis and biologics.  We look forward to serving you.

1401 Sheridan Rd
North Chicago, IL 60064
USA: +1 800 240 1043
Outside USA: +1 847 938 8524
abbviecontactmfg@abbvie.com
www.abbviecontractmfg.com


Advanced Analytical Labscitra
A combined experience of over 50 years in cGMP environments. Founded in 2008, Advanced Analytical Testing Laboratories is a GMP compliant, FDA regulated contract testing facility. It provides Analytical Testing, Research and Development and Consulting Services to Pharmaceutical, Biotechnology and other FDA regulated industries at cost effective prices.

30 Silverline Drive
North Brunswick, NJ 08902
Tel: 732-253-7373
www.advancedanalyticallabs.com


Alcami
At Alcami, we focus on the client experience. Our ten global locations provide customizable, end-to-end contract development and manufacturing solutions to small and mid-size pharmaceutical and biotechnology companies. Clients are connected at every level through one program manager allowing for faster turnaround times. For more information on Alcami’s integrated offerings and to view our virtual lab tours, please visit alcaminow.com

4620 Creekstone Drive
Durham, NC 27703
Tel: +1 866.239.1456
sales@alcaminow.com
alcaminow.com


Catalent Pharma Solutions
Catalent combines more than 85 years’ manufacturing expertise, quality assurance and reliable supply, with a global network of facilities to provide flexible and integrated commercial and clinical manufacturing solutions. As a collaborator and innovative solutions provider, Catalent has supported more than half of all new molecular entities approved by the FDA in the last ten years, and produces over 70 billion doses annually across a wide range of dose forms. Catalent has proven expertise in technology transfers and product launches, custom suite models and specialty handling (highly potent / DEA-licenced compounds) to support a wide range of manufacturing requirements.

14 Schoolhouse Rd.
Somerset, NJ 08873
Solutions@catalent.com
Tel: (1) 866-720-3148
Fax: 732-537-6480
www.catalent.com


CMIC CMO USA
CMIC CMO USA (CCU) is a member of the CMIC Group, the largest CRO in Japan with comprehensive solutions serving pharmaceutical and biotech clients from clinical to market. CCU is a contract development and manufacturing organization that specializes in drug formulation development, manufacturing of clinical trial materials and commercial drugs of oral solid dosage form.

Cedar Brook Corporate Center
3 Cedar Brook Drive
Cranbury, NJ 08512
Tel: 609-395-9700
www.cmiccmousa.com


CPL
CPL is a development and manufacturing company focused on services for non-sterile liquid and semi-solid pharmaceuticals.  Our facilities are registered and audited by FDA and Health Canada and maintain a solid compliance history.  Development services include formulation, clinical trial supplies, and scale-up. CPL’s commercial facilities support manufacturing of alcohol, light sensitive, or hormone-based products, and filling in tubes, bottles, jars, and sachets. Our GMP analytical lab provides product testing and stability management.

7600 Danbro Crescent
Mississauga,ON L5N 6L6 Canada
Tel: 905-821-7600
Fax: 905-821-7601
www.cplltd.com


Jubilant HollisterStier
Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer, able to manufacture sterile injectable, solid and semi solid dosage forms. Our facilities across North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. We provide a full-range of support and services to streamline the manufacturing process, such as on-site assistance from process qualifications and regulatory submittals through product release.

3525 N. Regal St.
Spokane, WA 99207
Tel: 800-655-5329
Fax: 509-484-4320
E-mail: info@jublHS.com
www.jublHS.com


Grand River Aseptic Manufacturing (GRAM)
Grand River Aseptic Manufacturing (GRAM) is a parenteral contract manufacturing organization supporting new product development and cGMP manufacturing. With a state-of-the-art cleanroom and highly trained staff, GRAM provides clinical trial and commercial material in vials or syringes for the life sciences industry.

140 Front Ave SW
Grand Rapids, MI 49054
Tel: 616-678-2400
bd@grandriverasepticmfg.com
www.grandriverasepticmfg.com


LonzaLonzalogo
At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need.  From drug substance to the final drug product, our solutions have been created to simplify your outsourcing experience and to provide a reliable outcome when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacture of a wide variety of biological and chemical drugs. We continuously invest to solve not just current, but also future challenges. Together, we can bring your next medicine to life.

101 International Drive
Portsmouth, NH 03801
Tel: 201-316-9200
pharma@lonza.com
www.lonza.com

 

Tedor PharmaTedor_Pharma_cc
Founded in 2001, Tedor Pharma is a specialized Contract Development and Manufacturing Organization (CDMO) with a strong track record of success in providing development and manufacturing services for oral solid dose products. Among our service offerings is FLEXITAB, which produces extended release tablets that can be taken intact or broken cleanly and precisely. TEDOR helps customers meet their project timelines, achieve regulatory approvals, and solve formulation challenges, from development through to large-scale manufacturing.

400 Highland Corporate Drive
Cumberland, RI 02864
862.207.1262
www.tedorpharma.com


Silver Sponsors

Chemic Laboratories
Chemic Laboratories is a privately held, full service, FDA Registered, cGMP, and GLP Contract Chemistry Organization (CCO) founded in 1998. Chemic offers unparalleled expertise in regulated QC monograph testing, CMC data production, Extractables/Leachables studies, and Small Scale cGMP manufacturing. Chemic clients range from established Fortune 100 pharmaceutical companies to virtual companies operating in the pharmaceutical, biotech, and medical device sectors.Through Quality, Commitment, and Service, our goal at Chemic Laboratories is to exceed your outsourcing requirements and expectations.

480 Neponset Street, Building 7
Canton, MA 02021
USA: +1 800 240 1043
Outside USA: +1 847 938 8524
abbviecontactmfg@abbvie.com
http://www.chemiclabs.com


ExeleadExelead
Exelead is a CDMO focused on LNP-based, sterile drug products. We specialize in contract manufacturing for complex, parenteral therapeutics—working to guide organizations through development and commercialization to get their drug to market. Exelead offers an end-to-end solution, including targeted expertise, flexible production, global distribution and stringent quality control.

6925 Guion Road
Indianapolis, IN 46268
Tel: 317-347-2800
info@Exeleadbiopharma.com
www.exeleadbiopharma.com


Pharma Packaging SolutionsPharma Packaging Solutions (PPS) is a turn-key contract packager offering bottling, blister packaging, folding carton production, kitting, vial/ampule and parenteral labeling. Serialization ready and GDUFA compliant, PPS can meet special requirements like products requiring a low RH primary packaging suite, RoW packaging, and Brite Stock labeling, and PPS is located within a day’s drive of 75% of the US population, very near major 3PL’s and distributors.

341 JD Yarnell Industrial Parkway
Clinton, TN 37716
Tel: 800-533-7744
www.PharmaPackagingSolutions.com
Whiteboard Capabilities Video


SGS Life Science ServicesSGS
SGS Life Science Services is a leading contract service organization providing analytical development, biologics characterization, biosafety, and quality control testing. With the largest global network of 17 laboratories in 10 countries, services include: analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, and protein analysis. Additionally, we offer Phase I-IV clinical services.

75 Passaic Avenue
Fairfield, NJ, 07004
Tel: 973-244-2435
www.sgs.com/en/Life-Sciences


Bronze

Coating Place
Coating Place is the leader in Wurster fluid bed formulation development and manufacturing. CPI provides a complete range of services from bead layering, extrusion / spheronization, and roller compaction to capsule filling and tableting. We process both solvent and aqueous formulations. Facilities are DEA licensed and FDA registered.

200 Paoli St.
Verona,WI 53593
Tel: 608-845-9521
www.coatingplace.com


Element HR Element Logo
Element’s Health Sciences Division offers consulting and analytical testing solutions for the pharmaceutical, medical device and biotech industries. Our facilities operate under GLP/GMP. We provide a wide range of CMC development services and clinical manufacturing (Phase I & II) for IND/NDA/ANDA drug products, specializing in parenteral, topical and ophthalmic products. We have an established expertise in method development & validation, harmonized compendia testing, E&L programs for manufacturing equipment, transdermal, inhalation, injectable, and combination medical device products. Our goal is to offer comprehensive solutions tailored for successful product approvals.  Our relationships are built on expertise, partnerships and trust.

1300 First State Blvd, Suite C
Wilmington, DE 19804
Tel: 302-636-0202
www.element.com

ILC DoverILC Dover
Innovators at our core, we develop engineered solutions for our customers’ complex problems. Recognized globally for our flexible containment solutions, ILC Dover serves customers in a diverse range of industries, including pharmaceutical and biopharmaceutical manufacturing, personal care, food and beverage, chemical, aerospace, healthcare and government agencies. At ILC Dover, quality is a culture, not a measurement.

One Moonwalker Road
Frederica, DE 19946
Tel: 302-335-3911
customer_service@ilcdover.com
www.ilcdover.com

Frontage LaboratoriesFrontage_Booth2_VF_Expanded
Frontage Laboratories, Inc. is a CRO providing integrated, scientifically-driven research, analytical and development services throughout the drug discovery and development process. With an outstanding compliance history, the CMC (Chemistry, Manufacturing and Control) team operates under strict adherence to ICH and US FDA GMP guidelines. Our broad portfolio of CMC services spans drug product development, analysis, and clinical trial materials’ delivery and supply, from preclinical stages through Phase II clinical trials.

CMC Services and GMP Manufacturing
75 East Uwchlan Avenue
Suite 100
Exton, PA 19341
www.frontagelab.com


Groupe PARIMA
Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO) specialized in the development and manufacturing of liquids, suspensions, semi-solids and sprays. We can support the full life-cycle of your product from initial development and clinical lots to full commercial scale manufacturing. We currently develop and manufacture various NDA, ANDA and OTC products. We are GDUFA licensed.

4450 rue Cousens
Montreal, QC, H4S 1X6
Tel: 514-338-3780
bd@groupeparima.com
groupeparima.com


Mikartmikart
Since 1975, Mikart has been a recognized leader in providing contract manufacturing, product development, and packaging services to the pharmaceutical industry.  We offer a broad range of capabilities including formulation development, analytical services, regulatory services, solid and liquid dose manufacturing, low humidity manufacturing, packaging (bottles, blisters, unit dose liquids, multi-laminate pouches and bottle powder fill), cold storage and serialization.

1750 Chattahoochee Ave
Atlanta, GA 30318
Tel: 888-4MIKART
www.mikart.com


PCI
The global healthcare industry trusts PCI for the development solutions that increase products’ speed to market and opportunities for commercial success. Only PCI brings the proven experience that comes with more than 50 successful product launches a year and over four decades in the healthcare business. Leading technology and continued investment enables us to address development needs throughout the product life cycle — from Phase I clinical trials through commercialization and ongoing supply. Our clients view us as an extension of their business and a collaborative partner, with the shared goal of improving patients’ lives.

Corporate office:
3001 Red Lion Road
Philadelphia, PA 19114
Telephone: 215-613-3600
Sales@pciservices.com
www.pciservices.com


 

Selkirk Pharmarendered
Selkirk Pharma was founded by a team of physicians and pharmaceutical industry leaders with one goal in mind: improve the reliability of drug product supply. We are building Selkirk Pharma operations from the ground up with singular focus on reliability. Our site is designed and built specifically for the aseptic manufacture of injectable drug products using state of the art filler technology that is combined with the latest in isolator technology.

827 W First Avenue, Suite 401
Spokane, WA 99201
info@selkirkpharma.com
www.selkirkpharma.com


 

Wavelength Pharmaceuticals
wavelength-logo-CMYKWavelength Pharmaceuticals is the independent API company of choice for pharmaceutical industry leaders. Our world class cGMP facility is producing 250MT of 40 products, serving more than 250 customers in 50 countries and having more than 30 years of exceptional regulatory track record with all leading global regulatory. We are experts in complex chemistry, innovative process development, crystalline forms and particle design and we offer customized solutions to meet individual customer requirements including CDMO services.

Raymond Alsko
Director Sales and Key Accounts NA
M: +1-973-832-9260
raymond.alsko@wavelengthpharma.com
www.wavelengthpharma.com