BIOVIA

Since its founding in 1992, bioWORLD has established, maintained, and succeeded in its core mission to manufacture and supply high-quality molecular tools, biological reagents, and laboratory supplies to analytical laboratories, academia institutions, and research corporations globally. bioWORLD specializes in numerous product lines for the Life Sciences and Biotechnology industries. With product focuses including bioAffinity reagents for protein purification and proteomics research, recombinant proteins and synthetic peptides, plant, microbiological, animal, and yeast media, and many other fields. In addition, bioWORLD offers services including custom peptide synthesis and antibody production.

The company's headquarters are in Dublin, Ohio, with sales offices located across the globe. Through both in-house manufacturing and supply chain acquisitions, bioWORLD supplies products to biomedical and life sciences industries. In addition, we provide custom laboratory services and formulations for R&D in the biotechnology industry. bioWORLD is a growing company, with both domestic channel partners (i.e. Fisher Scientific, Spectrum Chemical, Thomas Scientific, etc.) as well as established international distribution partners in 45 countries.

Lifecore Biomedical partners with pharmaceutical and biotech companies to manufacturer difficult to formulate and fill injectable drug products for clinical trials and commercial production that help improve patient lives. Our expertise stems from decades of experience manufacturing highly viscous pharmaceutical grade sodium hyaluronate.

Lifecore Biomedical is the global leader in manufacturing and supplying sodium hyaluronate (NaHy) for highly viscous injectable drug products. Over the past 30 years, more than 90 million patients have benefited from our certified pharmaceutical grade NaHy. Now we are using our expertise to expand our contract development and manufacturing services to solve the most complex drug development challenges.

Development
• Formulation and Process Development
• Analytical Method Development
• Stability Testing
• Technology Transfer
• Equipment Design and Procurement
• Pilot Batch Sizes for Syringe and Vial Configurations
• Quality Systems Experience in Pharmaceutical and Medical Device Regulations
• Regulatory Support

Clinical and Commercial Manufacturing
• Formulation
• Sterile Filtration of Highly Viscous Solutions
• Aseptic Filling into Syringes or Vials
• Secondary Sterilization
• Final Packaging
• Global Supply Chain Management
• Large, Efficient Batch Sizes

Pharmaceutical and Research Grade Sodium Hyaluronate
• Hyaluronan is a physiological substance that is widely distributed in the extracellular matrix of connective tissues in both animals and humans.
• Lifecore’s sodium hyaluronate is produced by an efficient microbial fermentation and purified by a highly effective purification process. It is produced in large batches to promote consistency in supply and customer convenience.
• Pharmaceutical grade sodium hyaluronate is available as a powder in a broad range of molecular weights for use in various medical applications (150KDa – 1.8MDa). Sterile pharmaceutical grade sodium hyaluronate is available in select molecular weights.
• Primary medical applications include: Ophthalmology, Orthopedics, Aesthetics, Tissue Engineering, and Veterinary Medicine

Our robust Quality System has been forged from our extensive experience with producing drugs and medical devices for a diverse group of partners over the last 25 years. We continue to learn from our industry partners and global regulatory authority audits to improve and implement best practices in our Quality System.

The Lifecore facilities are US FDA Drug and Device Registered and have GMP (EU, Japan, and Brazil) and EN ISO 13485 certifications. Our facilities are conveniently located in the central United States just outside of Minneapolis, Minnesota.

Teknova expedites clinical breakthroughs by allowing scientists to focus on discovery, product development, and production. An established leader in custom manufacturing for the life science, biopharma, and healthcare industries, Teknova provides critical reagents for bioprocessing, bioproduction, and molecular diagnostics. Product offerings include cell culture media and supplements, protein and nucleic acid purification buffers, and molecular biology reagents.

Priding itself on its agility and customer centricity, Teknova meets the most complex formulation and packaging requirements and delivers with unrivalled speed. The company supports research, clinical, and applied markets with catalog and custom products, delivering cost savings for research, development, and production of diagnostics, vaccines, and therapeutics. All products are manufactured in facilities that are ISO 13485:2016 certified, US FDA 21 CPR Part 820 compliant, and FDA registered.

As a partner to the biopharma sector, Teknova provides end-to-end solutions in the development of reagents and processes for a multitude of established and emerging applications, including vaccine production and gene therapy. The company’s R&D team offers expertise from prototype product design to guidance on GMP manufacturing of media, buffers, and reagents for the entire gene therapy workflow.

Teknova was founded in 1996 by Ted Davis, a Genentech scientist, who identified the need for custom media and buffers manufactured to the same quality standards as commercially available, inventoried solutions. The company headquarters and research services facility are located near the San Francisco Bay Area in Hollister, CA, USA, with additional facilities in Mansfield, MA, USA.

DRK Pharma Solutions is a premier solution provider to the pharmaceutical and biopharmaceutical industries in the areas of product development, clinical research and contract manufacturing through highly experienced professionals, world-class infrastructure and focus on timely delivery.

DRK Pharma Solutions provide process/product development and manufacturing solutions through collaborative partnership models. We also have broad range of proprietary generics products available for technology transfer.

DRK Pharma Solutions offers end-to-end clinical trial services to the global Bio/Pharmaceutical industries.

DRK Pharma Solutions also offers Contract Manufacturing services through its vast network of contract manufacturing organizations in Europe and Asia that offers a full portfolio of services for sterile and non-sterile products from pre-formulation to commercial supply worldwide.

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging