Biodextris

Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world’s first clinical glucose-responsive insulin at SmartCells, Inc., Akston’s COVID-19 vaccine candidate is in Phase II trials in the Netherlands. It has partnered with Dechra Pharmaceuticals PLC to commercialize once-a-week canine and feline insulin therapies. The company employs 35 people, has over 3,500 ft2 of research laboratory space and a 12,400 ft2 GMP clean room biologics manufacturing facility.

Avitide discovers, develops, manufactures and supplies custom and catalog biopharmaceutical affinity purification solutions to the biopharmaceutical industry. Avitide’s proprietary AVIPure™ affinity ligand portfolio sets the standard for precise affinity separations and consistent robust performance for its high-valued chromatographic products. Avitide develops these technologies with an industry-leading 3-month, concept to resin delivery service timeline that enables industry biopharmaceutical manufacturers and contract developers to achieve faster bioprocess development timelines, improved process economics, predictable scalability, and enable next-generation integrated continuous downstream processing. Avitide’s commercial resin manufacturing and supply operates under an ISO 9001:2015 quality management system and has been successfully audited for its quality systems and continuity of supply plan for its affinity chromatography products. Avitide has successfully deployed affinity purification technologies towards an array of biological molecules including enzymes, bispecific antibodies, therapeutic scaffolds, growth factors, hormones, insulins, blood factors, Fcfusions, cell-based therapies, vaccines, and gene therapy viral vectors. Avitide's management team brings substantial industry expertise and a successful track record in commercializing innovative biopharmaceutical manufacturing platforms. Avitide is financed by premier venture capital and private equity firms, including Polaris Venture Partners, OrbiMed Advisors, Mithril Capital Management, Sands
Capital Ventures, Section 32, SV Health Investors, Borealis Ventures, and NeoMed Management. For more information, visit www.avitide.com.

Lyophilization Technology, Inc. is a unique Technical Service and Contract Development and Manufacturing Organization. LTI provides comprehensive in-house capabilities ranging from thermal analysis, product design, formulation development, process engineering, streamlining operations, improving compliance, preclinical to Phase II clinical material preparation and technical support for a wide variety of products.

LTI has successfully developed formulations, manufacturing processes and prepared material for clinical trials for a wide variety of products.

• Anti-infectives
• Biologics / Vaccines
• Oncolytics / HPCs
• Small Molecules / Therapeutics

Development Services are conducted with product quality and a manufacturing mindset from the start, considering product administration, stability and processing requirements. Distinct processing areas are comprised of ISO 5 clean rooms directly linked to pilot-scale lyophilizers.

Clinical Manufacturing Area (CMA) is flexible for preparation of products with unique requirements, adheres to aggressive project timelines, and is fully cGMP compliant.
• Pre-clinical to Phase II Clinical Material
• Dedicated / disposable product contact items/equipment
• Combined aseptic processing with product containment
• Vials 2 to 100 mL and novel delivery systems
• US / EU complaint

Technical Services
The broad range of experience in a wide variety of products provides a specialized expertise from which you can capitalize.

Nanotherapeutics is a privately-held emerging biopharmaceutical company with both proprietary platform technologies and a diversified pipeline of products. The Company has expertise in pre-clinical and clinical development, formulation optimization, and cGMP manufacturing of biopharmaceutical products and medical devices. The Company's proprietary platform technologies can be used with all drug types, ranging from small molecules to proteins and vaccines.

Many of our diversified products have multiple indications ("dual-use"​) with potential in the areas of infectious diseases, CNS, oncology, vaccines, and biodefense. Over the past several years, we have focused our efforts on meeting the US government’s interests to develop safe, effective medical countermeasures against certain biological and radiological threats.

Smart Consulting Group provides technical and regulatory compliance support for biotechnology, medical devices, pharmaceuticals, vaccines, and specialty products, solving complex challenges for both the industry and governments.

We provide advisory and support services in a broad range of categories, including but not limited to:

• FDA Regulatory Compliance
• Quality Systems Design and Implementation
• Forensic Analysis for Data Integrity
• GMP, GLP, and GCP Audits
• Assessments and benchmarking
• Compliance and Quality Risk Assessment
• Regulatory Strategy
• Product/Process Development/Manufacturing
• Laboratory Compliance and Operations Analysis
• Documentation Management Support
• Project Management
• Technology Transfer Strategy and Oversight
• Staffing support for highly specialized talent
• Support services to facilitate organizational change

Smart Consulting Group has expertise in solid dosage forms, parenteral pharmaceuticals, a wide range of biological products, vaccines, recombinant products, monoclonal antibodies, cell therapies, tissue-engineered products, and device-combo products.