Precision ADVANCE, a collection of interconnected services and complementary teams across Precision for Medicine, Project Farma, and Precision Value & Health are uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring a cell or gene therapy to market.
Since 2013, Precision ADVANCE has helped advanced therapy innovators with 50+ cell and gene therapy clinical studies, 40+ facility builds and capital expansions with $4B+ in investment and supporting 70%+ of approved cell and gene therapies on the market.
From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities to our labs, training centres and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world’s leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.
Advanced Medicine Partners
Advanced Medicine Partners delivers what patients deserve and what regulators expect.
We provide process development, manufacturing, analytical development and testing for advanced medicines, specializing in viral vectors for gene and cell therapies. Our proprietary AAV manufacturing process minimizes impurities and generates industry-leading functional full capsid ratios. We bring extensive operational experience and have manufactured 350+ non-GMP batches and supplied 20+ preclinical studies, including IND-enabling efficacy and GLP toxicology.
After decades at biotech companies, we understand what it’s like to depend on a partner to deliver. Let us be your extended workbench!
AGC Biologics is a global CDMO providing end-to-end pharmaceutical development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, we have the resources and the available capacity you need to accelerate your race to GMP. From development to clinical trials to full-scale commercialization, we can help you reach your goals at any stage in the drug development and manufacturing process.
We specialize in the following modalities and substances, mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA, viral vectors, Messenger RNA (mRNA) and genetically engineered cells. Our services range from Process Development, Analytical Development, cGMP Manufacturing, Quality Control and Quality Assurance and Process Validation.
Matica Biotechnology is a CDMO providing fully integrated cell and gene therapy development and manufacturing services. With industry-leading expertise in GMP manufacturing of bulk and final drug product, cell line development, process development, and assay development, Matica Bio supports its clients with expertise and streamlined operations from bench to filing. Its state-of-art facility in Texas, has redefined excellence in the CDMO domain through innovative technology such as single-use technologies and in-line process monitoring to deliver cell and gene therapies faster, safer and at the highest level of quality. Our mission is to advance therapies from idea to patient.
VintaBio provides cell and gene therapy manufacturing services to pharmaceutical, biotechnology, academic and government organizations that are developing drugs for use in clinical trials. VintaBio has experienced staff to drive efficiency and produce high quality cGMP grade viral vectors. Current vector capabilities include, but are not limited to, adeno-associated virus (AAV) and lentiviral vectors (LVV).
Worldwide Clinical Trials
Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications, from discovery to reality. Our full-service clinical development capabilities include bioanalytical laboratory services and Phase I-IV clinical trials, as well as post-approval and real-world evidence studies – all powered by our talented and accessible team of clinicians, scientists, and researchers who bring their first-hand expertise to each clinical program.
At Worldwide, we understand that each customer and project are unique, so we take a collaborative and personalized approach to identify and meet specific needs and goals. Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We apply this deep therapeutic knowledge to develop flexible plans and quickly solve problems in the rapidly evolving clinical development landscape.
Our term of 3,000+ professionals spans 60+ countries, and believes that through collaboration, and a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays an important role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.
For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Cryoport Systems is the market leader in globally integrated temperature-controlled supply chain solutions for critical, irreplaceable products and materials in the life sciences industry. We are already trusted to support over 650 active clinical trials and 10 leading commercial products worldwide - delivering unparalleled, integrated supply chain services for products, therapies and treatments requiring unique, specialized temperature-controlled management. And, as the life sciences constantly evolve and advance, so do we.
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.
Polysciences is proud to introduce Kyfora Bio, our bioprocessing brand, supporting development of cell and gene therapy (CGT) breakthroughs from bench to clinic. Backed by 60+ years of specialty chemical development, manufacturing, and application expertise, Kyfora provides research grade through cGMP transfection reagents and excipients for viral vectors, mRNA vaccines, and other drug delivery applications. Our cost-effective and scalable cGMP processes empower advanced therapies to improve patients’ lives.
Founded in 2009, Boston Biodevelopment is a premium regulatory consulting firm of highly experienced professionals, including heads of regulatory affairs, advising on regulatory strategy and providing hands-on regulatory leadership throughout development.
Our consultants offer deep expertise across a wide range of therapeutic areas and rare diseases, and excel at guiding the regulatory development of biologics, small molecules, cell and gene therapies, and gene editing products through the entire product lifecycle.
Clients come to us when they need an immediately effective regulatory partner to help meet their development goals and bring the promise of life science to patients.
Compliance Architects® specializes in navigating complexity and helping companies develop robust regulatory strategies to ensure long-term success. We assist you in ensuring that phase-appropriate compliant systems are in place, ensuring your program remains aligned with current standards while staying ahead of the curve. Our services include assisting your organization with interim operational leadership, CMC development support, commercialization assistance and controls, tech transfer, audit readiness, Training, Remediation, and other related services.
Gene Therapy Net
Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network for the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines
Pharma Journalist is a paramount B2B online magazine platform exhibiting targeted and succinct information concerning the world of Pharmaceutical Industry therefore keeping a tab on the updated and latest updates and trends concerning the field.
Our widespread and market specific content write-ups cater to Industry professionals intending to keep pace with this dynamic and revolutionary industry. Articles like the latest news, trends, analysis, market reports, press releases, whitepapers, case studies, etc. enable further insight as well as an in-depth interpretation of industry trends.
Our editorial staff is committed to disseminating concise facts and information to its readers and subscribers by collating credible information from known sources and decoding them in the form of innumerable content pieces. Ranging from objective facts to subjective, analytical studies enables a holistic view of the topics scouted for.
It is noteworthy that Pharma Journalist which is a product of Kellen Media also offers a plethora of online marketing services aiding companies and organizations to reach out to targeted audience based on the geographical and demographic profiles ensuring enhanced reach and visibility garnered for their products or events paving way for accentuated brand awareness.
The Medicine Maker
In 2020, Cell and Gene launched its newsletter, dedicated to serving this distinct community within the pharmaceutical industry. Our purpose is not to add to the online noise, but to share compelling content through our newsletter and social channels. Coverage of the field is intentionally broad – from logistics and people to the technologies driving the industry forward.
With high-level insight, Cell and Gene from The Medicine Maker is committed to the people and innovations shaping the world through advanced medicine.
Medhealth Outlook offers insights into the latest technologies and trends in the healthcare, pharma, and medical industries. Our publication provides a balanced perspective through an inside/outside approach, showcasing interviews, features, and stunning artwork. As your inspiring source for in-depth journalism covering the tech community powering the medical industries, we strive to present valuable insights in both print and online formats.