BioKinetics offers help for bioprocess skills shortage

By Phil Taylor

- Last updated on GMT

Related tags: Biotechnology, Good automated manufacturing practice

Bioprocessing consultancy specialist BioKinetics has unveiled a
series of online training modules designed to address skill
shortages that it says are a major issue facing
biopharmaceutical manufacturing operations.

Five years ago there was a concern that with a raft of new biologic agents coming through the biopharmaceutical industry pipeline, manufacturing would be in undercapacity. That situation did not come about, a consequence of hefty investment in biofacilities. But there are concerns about a shortage of skilled, trained workers to work in those facilities, according to Tony Contino, who heads up BioKinetics. "A report by BioPlan Associates in 2005 that polled more than 1500 respondents found that a shortage of trained and experienced production staff was the top challenge facing biopharmaceutical developers and contract manufacturers​," said Contino in an interview at the Interphex conference in Philadelphia last week. BioKinetics, which hit the headlines last month after its acquisition by US-headquartered engineering specialist Foster Wheeler, introduced a training website - www.biopharminstitute.com​ - designed to tackle some of that skills shortages. "Our training modules draw on more than 1,000 person-years of biopharm engineering and validation experience​," according to Contino. The courses are designed to be carried out at the learner's own pace, and typically each module will take around an hour to complete and be priced at around $200. They are designed across non-proprietary topics in areas such as engineering, validation and quality systems. "Courses are designed to span a range of sophistication and technical depth to provide instruction on everything from the basics of operations and terminology for biopharmaceutical manufacturing to detailed guidance on the design, operation and validation of bioreactors, downstream unit operations and critical utilities and support systems​," according to BioKinetics. A list of the modules offered by BioKinetics, and their projected dates of availability, is appended at the end of this article. In addition, the company says it can develop bespoke courses for clients seeking to train their staff in a particular area. While the courses are all designed to fit in with the principles laid down in the American Society of Mechanical Engineers standards on BioProcess Equipment (ASME-BPE), as yet they are not recognised by the society. "But certification is something we are actively pursuing​," Contino told in-PharmaTechnologist.com. Post-merger prospects ​ The acquisition by Foster Wheeler has given BioKinetics a conduit to expand its consultancy services outside its stronghold in the US, he said, and also bolsters its offering in areas such as facility construction management, which is one of Foster Wheeler's core activities. "We can now advise on a bioprocessing project from design right through to construction​," said Contino. For Foster Wheeler, the acquisition provides it with a platform to expand its presence in the US biotechnology sector. At the time of the deal, Foster Wheeler's president and chief operating officer, Umberto della Sala, said: "the pharmaceuticals, biotechnology and healthcare market is a core segment for Foster Wheeler and is one in which we are committed to growing our market share. It strengthens our position relative to key US pharmaceutical companies seeking to invest in the US and globally.​" There are a lot of interesting developments in the bioprocessing arena at the moment, according to Contino, who believes becoming part of Foster Wheeler has given BioKinetics a great opportunity to bring its expertise to clients around the world. The top trends in his view include the shift towards continuous processing, within a framework of process analytical technology (PAT), and the continuous efforts to drive up bioreactor titres so that more material can be made in smaller facilities. "The move towards personalised medicine, with companies providing targeted therapies to smaller numbers of patients, demand this​," said Contino. Biopharminstitute.com - modules and dates of availability General Topics ​ Introduction to Biopharm Manufacturing 07-Mar-08 Introduction to Facility Design - Course 1 20-Mar-08 Introduction to Facility Design - Course 2 24-Apr-08 Introduction to Safety in the Biopharm 27-Feb-08 Reviewing Novel Biopharm Processing Technologies ​ Economics of Disposable Processing Equipment 20-Mar-08 In-Line Buffer Dilution 11-Jul-08 Use of Chlorine Dioxide for Sanitization 11-Jul-08 Implementing Process Analytical Technology 24-Apr-08 Getting Real Value from your Simulation 11-Jul-08 Design & Specifying Equip for Biopharm ​ General Equipment Design Guide - Course 1 06-Mar-08 General Equipment Design Guide - Course 2 11-Mar-08 Bioreactors - Course 1 10-Mar-08 Bioreactors - Course 2 13-Mar-08 Chromatography Skids 29-May-08 Chromatography Columns 29-May-08 Column Packing Systems 29-May-08 Filtration Systems 13-Mar-08 CIP Systems - Course 1 13-Mar-08 CIP Systems - Course 2 03-Apr-08 High Purity Water Systems 26-May-08 Waste Inactivation 26-May-08 Piping Liquid Wastes 26-May-08 Design & Selecting Instrumentation for Biopharm ​ On/Off Ball Valves 14-Jul-08 Control Valve 14-Jul-08 Coriolis Flow Meters 14-Jul-08 On/Off Diaphragm Valves 14-Jul-08 Pressure Regulators 14-Jul-08 Pressure Transmitters 14-Jul-08 Temperature Transmitters 14-Jul-08 Process Eng Typical Calculations for Biopharm ​ Clean In Place Water/Chemical Usage 14-Jul-08 Clean Steam Usage during SIP 25-Apr-08 Jacketed Vessel Heat Transfer 14-Jul-08 Heat Exchanger Sizing 14-Jul-08 Compressible Fluid Line Sizing 14-Jul-08 Non-Compressible Fluid Line Sizing 14-Jul-08 Vent Sizing 14-Jul-08 Pump Sizing 14-Jul-08 Sanitary Vessel Sizing 14-Jul-08 Creating Process Eng Documents for Biopharm ​ Piping and Instrumentation Diagrams - Course 1 20-Mar-08 Piping and Instrumentation Diagrams - Course 2 25-Apr-08 Equipment Data Sheets 14-Jul-08 Equipment Lists 14-Jul-08 Process Flow Diagrams 05-Mar-08 Utility Flow Diagrams 14-Jul-08 Block Flow Diagrams 14-Jul-08 Quality Checking of Process and Piping ​Isometrics 14-Jul-08 Equipment Arrangements 14-Jul-08 Piping Drawings 14-Jul-08 Creating Validation Documents ​ Summary of GAMP Guidelines - Courses 1 20-Mar-08 Summary of GAMP Guidelines - Courses 2 20-Mar-08 Developing IQ / OQ/ PQ protocols - Course 1 20-Mar-08 Developing IQ / OQ/ PQ protocols - Course 2 20-Mar-08 Developing SOPs 20-Mar-08 Automation Topics ​Overview Automation Systems 03-Apr-08 Performing Factory Acceptance Testing ​Process Controls System 03-Apr-08 Sanitary Vessels 19-Jun-08 Sprayballs 19-Jun-08 Shell and Tube Heat Exchangers 19-Jun-08 Commissioning Equipment for Biopharm ​ Successful Commissioning 20-Mar-08 Design Qualification 10-Apr-08

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