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Bio-Manufacturing Development Consultant Service
Biotechnology consulting / Business transformation / Engineering / Education / Human resources (HR) Interim managers / Marketing / Process / Public-relations (PR) / Performance Property / Sales and Marketing / Strategy & Management
https://en.wikipedia.org/wiki/Bioprocess_engineering
https://en.wikipedia.org/wiki/Biological_engineering
https://en.wikipedia.org/wiki/Consultant
https://en.wikipedia.org/wiki/Biotechnology_consulting
https://old.www.biopharm.org.tw/download/Biotechnology_Industry_in_Taiwan_2018.pdf
http://www.chromnet.net/Bio-Community.aspx 


Bioreactor

Bioprocess engineering, also biochemical engineering, is a specialization of chemical engineering or Biological engineering, It deals with the design and development of equipment and processes for the manufacturing of products such as agriculture, food, feed, pharmaceuticals, nutraceuticals, chemicals, and polymers and paper from biological materials & treatment of waste water. Bioprocess engineering is a conglomerate of mathematics, biology and industrial design,and consists of various spectrums like designing of bioreactors, study of fermentors (mode of operations etc.). It also deals with studying various biotechnological processes used in industries for large scale production of biological product for optimization of yield in the end product and the quality of end product. Bioprocess engineering may include the work of mechanical, electrical, and industrial engineers to apply principles of their disciplines to processes based on using living cells or sub component of such cells.[1].

Biological engineering Biological engineering, or bioengineering/bio-engineering, is the application of principles of biology and the tools of engineering to create usable, tangible, economically viable products.[1] Biological engineering employs knowledge and expertise from a number of pure and applied sciences,[2] such as mass and heat transfer, kinetics, biocatalysts, biomechanics, bioinformatics, separation and purification processes, bioreactor design, surface science, fluid mechanics, thermodynamics, and polymer science. It is used in the design of medical devices, diagnostic equipment, biocompatible materials, renewable bioenergy, ecological engineering, agricultural engineering, and other areas that improve the living standards of societies.

Sub-disciplines

Depending on the institution and particular definitional boundaries employed, some major branches of bioengineering may be categorized as (note these may overlap):



A ribosome is a biological machine that utilizes protein dynamics


A consultant (from Latin: consultare "to deliberate") is a professional who provides expert advice[1] in a particular area such as security (electronic or physical), management, education, accountancy, law, regulatory compliance, human resources, marketing (and public relations), finance, health care, engineering, science or any of many other specialized fields.

In the business, and as of recently the private sphere, the most commonly found consultants are:


Biotechnology consulting (or biotech consulting) refers to the practice of assisting organizations involved in research and commercialization of biotechnology in improving their methods and efficiency of production, and approaches to R&D. This assistance is usually provided in the form of specialized technological advice and sharing of expertise. Both start-up and established organizations would hire biotechnology consultants mainly to receive an independent and professional advice from key opinion leaders, individuals with extensive knowledge and experience in a particular area of biotechnology or biological sciences, and, often, to outsource their projects for implementation by well qualified individuals. Large management consulting firms would often be able to provide technological advice as well, depending on the qualifications of their consulting team. With the growth of pharmaceutical companies, biotechnology consulting has recently developed into an industry of its own and separated from the management consulting industry that traditionally also provides technological advice on R&D projects to various industries. This has also been fueled by the impact various conflicts of interests can have on commercialization when biotechnology organizations contract services from academic institutions or government scientists[1].


Biotechnology Industry in Taiwan
 Because of the international commercialization of biotechnology,the Taiwanese government has listed biotechnology industry as part of the key development program of emerging technologies. Taiwan's biotechnology research and development (R&D) capacity can be enhanced by initiating relevant talent cultivation and R&D projects.

In 2007, Taiwan proclaimed the implementation of the Act for the Development of Biotech and New Pharmaceuticals Industry to provide tax reductions in terms of technology R&D, talent cultivation, and capital for firms engaged in biotechnology and new pharmaceutical development. By the end of May 2018, the total number of biotechnology and new pharmaceutical firms reached 134, with the firms developing 322 approved biotechnology and new pharmaceutical items; 42 of these items have obtained marketing approval.

Because of the continual growth of items that have been granted marketing approval, Taiwan's biotechnology industry is expected to progress swiftly and robustly.....

Leading with Quality, Performance and Cost
 The rapid developments of bio-pharmaceutical knowledges and technologies, such as such as Recombination, NGS, and Gene Editing, etc. in recent decades, have strongly supported pharmaceutical and medical products inovations and productions such as AntiBody, Vaccine, Protein, Enzyme, and advanced Medical devices, etc.
And being one of the most dedicated partner and distributor in Taiwan in majority for the Bio-science, Pharmaceutical, Food, Cosmetic communities, we have positively links and co-effort with some professional Biotechnology consulting entities, with their professional and advanced professional backgrounds. Most of our principal consultant partners have 10-20 years of experiences in Biopharmaceutical Process Development, Regulation Compliance, and Marketing Developments,

Range of services :
Our consulting partners offers a range of services to the biopharmaceutical and biotechnology sectors, including : 

  • Technical and strategy
  • Experimental design and data analysis
  • Training and Education
  • Media optimization tools
  • Technical design and configuration of process lab equipment
  • Quality, Compliance and regulatory support
  • Process & Analytical Development
  • Outsourcing Management
  • Technical Program Management
  • Bioprocessing troubleshoot assistance
  • Technology transfer
  • Project management
  • Biologics process development and optimization
  • Scale-up and engineering biomanufacturing
  • GMP biomanufacturing
  • Opportunity Assessment
  • Property and Intellengence
  • Business Management
  • Process Economic Modeling
  • Marketing and Sales
  • Development Interim Managers.

Expertise and Experiences
We offer for the biotech, biopharma, pharma, diagnostic, and Med Tech companies taking on Business Development, Marketing & Sales, Procurement & Outsourcing, Pre-clinical & Clinical Development and GMP & Regulatory issues :

  • Mammalian cell culture
  • Harvest and primary capture processes
  • Microbial fermentation
  • Monoclonal antibodies and recombinant protein production
  • DNA vaccine and viral vector production
  • Experimental design Multivariate analysis
  • Media optimization
  • Process analytical technology
  • Bioprocess spectroscopy
  • Bioreactor design & control system configuration
  • Chromatography/DSP
  • Business development
  • Marketing and sales
  • Bioprocess development
  • Support for biopharma and Vaccine clients
  • Biotech facility engineering support(Korea, Finland), Key Plants(Sweden)
  • Global Market Analysis & Acquisition assessments
  • Upstream Bioprocessing
  • Modular construction and project management of a BSL-2 laboratory for Avian flu monitoring
  • Coordination of GMP reviews of stem-cell pilot plants(PIC/S)
  • GMP related training(PIC/S, FDA & EMA)
  • GMP audits of mAb production facilities for US Biotech.
  • GMP audit of Biosimilar & biologics facility (PIC/S and EU GMP)
  •  GMP & regulatory advice for the construction of a Cell & Gene Therapy production facility (CAR-T) PIC/S, EU GMP.
  • USFDA GMP of cell therapy company.
  • Vaccines platform co-development between Japanese and western vaccine companies.
  • Biopharma modelling (mAb) and review of CMOs.
  • Feasibility study to establish large scale FMD vaccine BSL-3 manufacturing facility.


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