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HTD Biosystems Inc.

Pleasanton, California, US

HTD is a private company located in Pleasanton, California. HTD has worked and collaborated with other companies, governments and academia. Our researchers have helped other companies develop their products. An example of a product that was formulated and developed at HTD Biosystems for a Japanese biotech company, is a liposomal formulation against graft-versus-host disease (GvHD) associated with hematopoietic stem cell transplantation (HSCT). This product is now in Phase II clinical trials.

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Spray Drying
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Agilent Bioanalyzer
Starting at $500.00 per chip

Capillary Electrophoresis using Protein Chip

The Agilent 2100 Bioanalyzer system is capable of rapid on-chip protein analysis with high reproducibility and accuracy regarding quantitation and sizing. Electrophoresis of denatured proteins is carried out in a sieving matrix and buffer containing SDS. Sensitivities of the... Show more »

Capillary Electrophoresis using Protein Chip

The Agilent 2100 Bioanalyzer system is capable of rapid on-chip protein analysis with high reproducibility and accuracy regarding quantitation and sizing. Electrophoresis of denatured proteins is carried out in a sieving matrix and buffer containing SDS. Sensitivities of the assays can exceed Coomassie Blue and silver-stained SDS-PAGE analyses.
The advantages include low sample requirement (4 uL), wide molecular range (5 KDa -80 KDa and 14 kDa - 230 KDa), broad protein loading capacity from pg/μL to μg/μL, < 3 % precision for sizing, < 6 % purity, < 1.5% impurity detection, 10 samples per run. Cost is per run.

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Agilent Bioanalyzer
NanoDSF
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We provide analysis of proteins on a label-free nanoDSF platform. Unlike normal DSF analysis where a fluorescent dye is often added to the sample, our platform is label-free and also does not interfere with formulation excipients (e.g. surfactants). Not only we get the Tm measurements but also information on protein aggregation... Show more »

We provide analysis of proteins on a label-free nanoDSF platform. Unlike normal DSF analysis where a fluorescent dye is often added to the sample, our platform is label-free and also does not interfere with formulation excipients (e.g. surfactants). Not only we get the Tm measurements but also information on protein aggregation (onset temperature of aggregation and amount of relative aggregation).

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Pharmaceutical Formulation
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HTD Biosystems accelerates development of biotech drugs, using a unique formulation development platform iFormulate. This concept is based on an efficient high throughput algorithm that utilizes rational design of experiments and formulation parameters, to develop pharmaceutically acceptable drug product. Protein formulation... Show more »

HTD Biosystems accelerates development of biotech drugs, using a unique formulation development platform iFormulate. This concept is based on an efficient high throughput algorithm that utilizes rational design of experiments and formulation parameters, to develop pharmaceutically acceptable drug product. Protein formulation development by iFormulate

Over the years we have helped our clients with development of their protein drug candidate into a stable drug product. We have developed high dose protein formulations and helped our clients overcome challenging formulation problems such as protein aggregation, and solubility problems. Using iFormulate platform, HTD helps with rapid antibody screening and selection for the most stable formulation.

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Viscosity Testing
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Moisture Analysis
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Particle Analysis and Characterization
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Dynamic Light Scattering
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Differential Scanning Calorimetry (DSC)
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Antibody Characterization
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Vaccines
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HTD has a vast experience with vaccines and over the years has developed several vaccines for its clients. The vaccines developed by HTD Biosystems are currently at different stages of clinical trials. HTD has been involved in development of traditional aluminum salt based vaccines (such as a pentavalent vaccine against Botulism)... Show more »

HTD has a vast experience with vaccines and over the years has developed several vaccines for its clients. The vaccines developed by HTD Biosystems are currently at different stages of clinical trials. HTD has been involved in development of traditional aluminum salt based vaccines (such as a pentavalent vaccine against Botulism) both as a liquid and as a freeze-dried product, cancer vaccines and other therapeutic vaccines for human and veterinary medicine. In these projects, HTD has collaborated with different stakeholders and partners, such as universities, small and large Pharma and International companies.

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Drug Delivery Systems
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With a combined expertise in protein formulation development, lyophilization, solid-state structure and liposomal drug delivery systems, HTD is the right partner for development of your next smart delivery system for delivering antibodies, immunotherapy medicines, anti-cancer drugs, antigens, vaccines, DNA and Proteins. We have... Show more »

With a combined expertise in protein formulation development, lyophilization, solid-state structure and liposomal drug delivery systems, HTD is the right partner for development of your next smart delivery system for delivering antibodies, immunotherapy medicines, anti-cancer drugs, antigens, vaccines, DNA and Proteins. We have extensive experience from pH sensitive liposomes, PEGylated liposomes, remote loaded liposomes and other forms of nano-particulate systems both as liquid and as freeze-dried products. Concepts developed at our company have been licensed to companies such as Pfizer by our clients.

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Protein Formulation
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Protein Characterization Services
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Pharmaceutical Freeze Drying
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We provide customized lyophilization services and develop efficient freeze-drying cycles for various biotech drugs ranging from small molecules, peptides, proteins, and drug delivery systems (e.g liposomes). Our expertise and experience in thermal analysis and solid state characterization helps us in developing robust lyophilized... Show more »

We provide customized lyophilization services and develop efficient freeze-drying cycles for various biotech drugs ranging from small molecules, peptides, proteins, and drug delivery systems (e.g liposomes). Our expertise and experience in thermal analysis and solid state characterization helps us in developing robust lyophilized formulations and freeze-drying cycles that can be efficiently tech-transferred to cGMP manufacturing facilities. Similar approaches are also applied to spray drying of drug products.

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Lyophilization
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HTD provides customized lyophilization services and development in the San Francisco Bay area. Our complete lyophilization services include:

  • Formulation development and lyophilization: of proteins, peptides, DNA, RNA, antibodies, antibody-polymer conjugates, vaccines, liposomes, diagnostic kits and small molecules.
    -... Show more »

HTD provides customized lyophilization services and development in the San Francisco Bay area. Our complete lyophilization services include:

  • Formulation development and lyophilization: of proteins, peptides, DNA, RNA, antibodies, antibody-polymer conjugates, vaccines, liposomes, diagnostic kits and small molecules.
  • Lyophilization Cycle Development: We characterize the pre-lyo solution by Differential Scanning Calorimetry (DSC) to determine glass transition temperature or collapse temperature in the frozen concentrate (Tg’). We then use a lab scale Vertis freeze-dryer to lyophilize the product. The product is usually sealed under vacuum or under a flow of an inert gas such as Nitrogen.
  • Characterization of solid-state properties: We use DSC and Karl Fischer to monitor solid-state structure (amorphicity) and moisture content of the lyophilized cake, respectively. The cakes are also reconstituted and reconstitution time is measured. The cakes are reconstituted and the molecular conformation of the API and its bioactivity is compared before and after lyophilization. Our experience in lyophilization and detailed characterization of the product during lyo development provides our clients with the necessary information for rationalizing the lyophilization cycle during development.
  • Stability studies: Lyophilized cakes are stored at cold, under ambient or accelerated condition and their stability is determined by different techniques.
  • Fill Finish For Tox Studies: We provide manufacturing of TOX lots for GLP testing. We use a Vertis pilot scale lyophilizer (Genesis 12 XL) with a capacity of 1,000 vials (3 mL). HTD has successfully manufactured several Tox lots for its customers.
  • Scale-up of Lyo cycles: Successful scale-up to a large production size dryer is critical for developing a pharmaceutically- acceptable product. Using our specially configured lyophilizer, we develop a robust lyo cycle that can be easily tech-transferred to a production scale.
  • Tech Transfer to large GMP lyophilizers: HTD has successfully lyophilized numerous drug products and transferred the process into manufacturing. Our pilot scale lyophilizer is specifically designed to mimic large production lyophilizers. We provide a rationale approach to the lyophilization cycle that becomes a critical component of the CMC section for submission to the regulatory agencies and manufacturing groups.
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Equipment
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Biology
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Biochemistry & Molecular Biology
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Protein Services
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Protein Expression
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Antibody Services
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Imaging & Spectroscopy
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Spectroscopy
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Scattering Techniques
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Chemistry and Materials
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Analytical Chemistry Services
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Material Testing Services
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Formulation Services
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Engineering and Fabrication
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Physical Analysis Methods
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Calorimetry
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Drug Discovery & Development
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Drug Discovery
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Drug Development
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