2601 Fortune Cr. East, Suite 301B
Indianapolis, IN 46241
Tel: +1 (317) 271-6082
Since CAI was founded in 1996, we have delivered over half a billion dollars in services for hundreds of clients across thousands of projects around the world. With offices in the US Canada, Australia, Netherlands, Korea, Switzerland, Ireland, Italy, China, Singapore, and Malaysia, we have built an international team of more than 600 professionals providing local support from a global company. Our engineering, technical, and consulting services are fashioned purposefully to develop mission-critical facilities at a high level of performance and reliability. When operational readiness and startup are critical, CAI helps deliver to a higher standard.
250 North Rt. 303
Congers, Ny 10920
Tel: +1 (845) 639-3700
For pharma customers worldwide, Aptar Pharma is the go-to drug delivery expert, providing innovative drug delivery systems, components and active packaging solutions across the widest range of delivery routes, including nasal, pulmonary, ophthalmic, dermal and injectables. Aptar Pharma Services provide early stage to commercialization support to accelerate and de-risk the development journey. With a strong focus on innovation, Aptar Pharma is leading the way in developing connected devices to deliver digital medicines. With a global manufacturing footprint of 14 GMP sites, Aptar Pharma provides security-of-supply and local support to customers. Aptar Pharma is part of AptarGroup, Inc. (NYSE:ATR). www.aptar.com/pharma
1 Manor Pkwy., Salem, NH 03079
Tel: +1 (603) 893-3758
Boston Analytical, the Life Sciences Division of Alpha
Analytical, is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to pharmaceutical and medical device companies worldwide, including analytical testing/method development, microbiological testing/EM services, stability testing/ICHcompliant storage, and extractables and leachables studies.
1 Ecolab Pl., St. Paul, MN 55102
Tel: +1 (651) 250-4718
Ecolab Life Sciences is a trusted partner in Pharmaceutical and Personal Care manufacturing. We provide comprehensive solutions and technical know-how focused on ensuring product quality and safety in the cleaning, sanitation, and contamination control areas, while improving operational efficiency.
2537 Rue Guenette
Saint-Laurent (Montreal), Quebec, H4R 2E9
Tel: +1 (514) 668-2835
The Novatek approach provides the building blocks for a complete quality management solution that can be tailored to any client’s needs. Our software can be used as standalone modules or integrated with other modules to form large-scale comprehensive solutions. With 24+ years of successful installations globally, Novatek has developed an extensive base of regulatory knowledge ensuring compliance and peace of mind during audits.
1311 Helmo Ave.
North Oakdale, MN 55128
Tel: +1 (651) 738-2728
We deliver CDMO / CRO services, from 5 sites, working alongside Pharma & Biopharma innovators to advance new therapies to market. Our teams have proven expertise with small molecules, biologics (such as proteins, peptides, antibodies, antibody drug conjugates) and gene therapies (such as RNA and DNA oligos). Our drug development services advance candidates from early pre-formulation and tox studies to an IND filing and on through the clinical phases. Our GMP clinical supplies manufacturing capabilities include sterile injectables, ophthalmics, capsules, tablets, solutions/suspensions, and topicals. Our commercialization and manufacturing support comes from our FDA-registered laboratories that provide submission-ready methods validation reports, finished product release testing, ICH Stability programs, raw materials clearance programs, extractable-leachable studies, and full microbiology laboratory support.
8 Skyline Drive
Hawthorne, NY 10532
Telephone: (914) 337-2005
PTI is a global leader in package testing equipment. We specialize in non-destructive package testing equipment for high risk packaging applications. PTI's inspection technologies are deterministic test methods that produce reliable and robust quantitative test result data. We specialize in testing solutions for all parenteral and biologic products including vials, pre-filled syringes, cartridges, auto-injectors, blow-fill-seal and other packaging formats. Leading technologies include MicroCurrent HVLD, Vacuum Decay and Helium leak detection. Complete container closure integrity (CCI) solutions for all lifecycle stages of pharmaceutical product development.
27905 Meadow Dr., Suite 9, Evergreen, CO 80439
Tel: +1 (303) 674-8333
bottelpack Advanced Aseptic liquid packaging systems meet any level of biosafety requirement with its Blow/Fill/Seal technology. Rommelag is moving forward in the pharmaceutical industry in two primary ways: higher capacity and more efficient Blow/Fill/Seal (BFS) systems, leveraging our contract manufacturing resources to safely allow new products to utilize BFS technology designed to test and produce biological products: vaccines, antibodies, enzymes, and immunological substances. We also provide services for container and closure development, clinical trials and commercial aseptic production.
425 Via Corta, Suite #203
Palos Verdes Estates, CA 90274
Tel: +1 (800) 333-6180
SQA provides outsourced supplier management programs for quality-critical industries, including fully-managed programs for audits, remediation, engineering, source inspection, corrective action management, and real-time quality metrics. SQA develops, implements, and executes supplier quality solutions that complement and extend client quality teams to secure and improve the global supply chain. Our dedicated program and technical management, combined with proven processes, leading-edge systems, and a global network of quality professionals in over 50 countries, offers superior visibility and control for any supplier quality initiative. | www.sqaservices.com
6060 Spine Rd., Boulder, CO 80301
Tel: +1 (720) 622-1089
SUEZ, through its Water Technologies & Solutions group and Sievers product line, offers deep expertise in ultrapure water quality monitoring, cleaning validation, and other life science applications. As experts in Total Organic Carbon (TOC), Conductivity, and Bacterial Endotoxins Testing (BET), we will help you optimize your environmental monitoring and cleaning programs. www.sieversinstruments.com
395 Oyster Point Blvd. Suite 228
South San Francisco, CA 94080
Telephone: (510) 445-0505
ValGenesis is the creator of the first paperless enterprise-wide software platform that serves as a foundation for managing compliance-based validation activities in the life science industry. Compliant with 21 CFR Part 11, Annex 11, GAMP 5 requirements as well as ALCOA+ guidelines, ValGenesis VLMS has become the industry’s most trusted electronic validation lifecycle management solution that leverages the power of many years of experience and knowledge supporting Artificial Intelligence (AI), Internet of Things (IoT), Robotics, Advanced Analytics, and Augmented Reality (AR) to help life science companies transform into ‘facilities of the future’ in their journey towards PHARMA 4.0.
15 Lee Blvd., Malvern, PA 19355
Tel: +1 (610) 644-8335
Innovators for Contamination Control, Veltek Associates, Inc. (VAI®) designs innovative solutions to address the control of particulate and microbial contamination in pharmaceutical, biotechnology, medical device, research & development, healthcare, and lab animal operations worldwide. VAI strives to develop meaningful technical relationships with our clients to ensure that VAI products meet, if not exceed, their unique requirements. VAI’s manufacturing and testing operations mirror current GMP/GLP standards. With 40 years of experience our products and services build upon each other to create a “Full Circle Approach” to cleanroom contamination control. Click on “Products & Services” to learn more.
6161 Imperial Loop, College Station, TX 77845
Tel: +1 (979) 431-0700
G-CON Manufacturing designs, builds and installs prefabricated cleanroom PODs. G-CON’s cleanroom POD portfolio encompasses a variety of different dimensions and purposes, from laboratory environments to personalized medicine and production process platforms. The POD cleanroom units surpass traditional cleanroom structures by virtue of their scalability, mobility and the possibility of repurposing the PODs once the production process reaches its lifecycle end.
Tel: + 49 (211) 618-1330
Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence, focus on quality and customers. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. With its products and solutions, Gerresheimer plays an essential role in people’s health and well-being.
395 Oyster Point Blvd., Suite 300, South San Francisco, CA 93080
Tel: +1(650) 243-5212
Start receiving your free copy today. American Pharmaceutical Review is a journal of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased, and informative editorial in the industry.
25 Phillips Pkwy., Montvale, NJ 07645
Tel: +1 (201) 825-2552 | Fax: +1 (201) 825-0553
CONTRACT PHARMA is the multimedia information outlet dedicated to bio/pharma outsourcing. From drug development to manufacturing, we cover the latest developments, views, and opinions from industry leaders in print and online.
219 Changebridge Rd., Montville, NJ 07045
Tel: +1 (973) 299-1200
Drug Development & Delivery is a print and digital publication exclusively committed to advancing the applied science, technology, and related business practices of pharmaceutical and biological drug development, including: * Drug Delivery Technologies * Controlled Release * Formulation Development * Bioavailability * Medical Devices/Combination products * Contract Services * Solubility Enhancement and more.
4350 East West Hwy., Suite 600, Bethesda, MD 20814
Tel: +1 (301) 656-5900 | Fax: +1 (301) 986-0296
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the bio/pharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of more than 10,500 members worldwide
485F US Hwy. 1 South, Suite 210, Iselin, NJ 08830
Tel: +1 (732) 596-0276
Pharmaceutical Technology offers news, analysis, and peer
reviewed research in formulation development (including
excipients) and drug manufacturing to more than 38,000
decision makers in the top pharmaceutical, specialty
pharmaceutical, and biotechnology companies via the
Pharmaceutical Technology print magazine, PharmTech.com,
and three newsletters: ePT, Sourcing and Management, and
the Equipment and Processing Report.
721 Arbor Way, Suite 100, Blue Bell, PA 19422
Tel: +1(610) 828-4090
IPS is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill and passion, IPS provides consulting, architecture, engineering, construction management, and compliance services that allow clients to create and manufacture life-impacting products around the world. Headquartered in Blue Bell, PA-USA, IPS is one of the fastest-growing companies servicing the life sciences industry with 1,500 professionals in the US, Canada, Brazil, UK, Ireland, Switzerland, Germany, Singapore, China, and India.
7670 First Place, Suite A, Oakwood Village, OH 44146
Tel: +1 (440) 703-3615
Oakwood Labs has 20+ years’ experience in development, scale-up, and manufacturing of sustained release microparticle depot formulations. Our technology enables encapsulation of small molecules, peptides, and proteins with a tailored release profile ranging in duration from one-week up to one-year. In addition to R&D, Oakwood operates a FDA approved sterile GMP facility for production of clinical trial material and commercial product. Oakwood has the ability to be a CDMO partner to take your product concept from feasibility to clinical phases or Oakwood can act as a CMO partner for manufacturing of sterile injectable products.
1501 E. Woodfield Rd., Suite 400N, Schaumburg, IL 60173
Tel: +1 (630) 467-1300 | Fax: +1 (630) 467-0197
Each issue of Pharmaceutical Manufacturing magazine reaches more than 25,000 operations and engineering professionals in the pharmaceutical and biotech industries. Our readers are responsible for ensuring the safe design, construction, and operation of one of the most highly regulated industries in the world
81 Columbia Turnpike
Rensselaer, NY 12144
Telephone: (518) 488-6000
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
11494 Sorrento Valley Rd., San Diego, CA 92121
Tel: +1 (888) 397-0107
DDE Labs specializes in drug-device combination product development and integration with commercial strategy and life cycle plans. Each of our experts has more than twenty years of experience in pharmaceutical research, development, and commercialization. DDE Labs provides contract product development for parenteral solution formulations to complex injectables and has a special expertise across most formulation and delivery technologies, including long-acting gels, particulates, and implants, to nasal and pulmonary inhalation.
One Amgen Center Drive
Thousand Oaks, CA 91320
Telephone: +1 805-447-1000
Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
1400 West Raymond St.
Indianapolis, IN 46221
Tel: +1 (317) 651-4026
Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better." More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live.
485F US Highway, Suite 210
Iselin, NJ 08830
Tel: +1 (732) 596-0276
BioPharm International integrates the science and business of Biopharmaceutical research, development, and manufacturing. BioPharm International provides practical, peer-reviewed technical solutions to enable biopharmaceutical professionals to perform their jobs more effectively.
5340 Fryling Rd, Suite 300
Erie, PA 16510
Tel: +1 (814) 897-7700
BioProcess Online is the leading source of technical information, industry knowledge, and content for the biotherapeutic community. From upstream to downstream processing through bioanalysis and biomanufacturing, our goal is to provide readers with the most up-to-date information about the issues, challenges, and news they care about most.
5340 Fryling Rd., Suite 300
Erie, PA 16510
Tel: +1 (814) 897-7700
Cell & Gene provides actionable information to professionals involved in the development and commercialization of cell and gene therapies. Through the original editorial published on the site, Cell & Gene facilitates the sharing of insights on challenges, trends, and best practices in this burgeoning field. Cell & Gene’s editorial scope spans the entire product lifecycle from basic research to commercialization.
555 Richmond Street West, Suite 402
Toronto, Ontario M5V 3B1
Tel: +1 (416) 361-3444 x 140
Founded in 2013, Tornado Spectral Systems Inc is a global provider of chemical analysis & measurement systems for Raman spectrometers. Bolstered by its patented High Throughput Virtual Slit (HTVS™) technology, Tornado’s HyperFlux Raman spectrometers deliver significantly enhanced photon collection power. The HTVS™ technology allows the best Raman measurement analysis currently achievable anywhere. The superior performance of Tornado’s HyperFlux™ PRO Plus Raman spectrometer system allows for more accurate chemical identification, and quantitation even with challenging mixtures and low concentrations, faster measurements of dynamic reactions, and low laser power operation in hazardous environments.
2 High Ridge Park
Stamford, CT 06905
Telephone: (203) 998-6176
ApiJect is revolutionizing how the world manufactures and delivers injectable medicines and vaccines. The ApiJect technology platform brings together simple, interconnectable components to create scalable drug delivery devices for global markets. At the center of these devices is the aseptic and cost-effective BFS fill-finish process. And, by using a modular manufacturing approach, these devices can be produced in clinical- or commercial-scale by ApiJect or the drug manufacturer.
Tel: +1 (301) 656-5900 ext. 160
Direct: (240) 688-4405
Email: [email protected]
Manager, Sales Administration
Tel: +1 (301) 656-5900 ext. 135
Email: [email protected]