Chromatography Cycle Success Improvements

Implementation of multiple corrective measures to improve the cycle success rate of 5 chromatography skids

Amgen

Cold Room Refrigeration System Upgrade

Installation of new chillers, AHUs, and controls systems to supply chilled air to cGMP clean rooms required to be maintained between 2-8C.

Amgen

CIP System Improvements

Baseline testing, troubleshooting, and corrective measures implementation of CIP circuits for over 50 individual pieces of cGMP processing equipment

Amgen

Roof Replacement

Project and construction management of a project to replace the roof over an operating cGMP biotech manufacturing facility without impacting production activities

Amgen

Bulk Specialty Gas Delivery System

Design and installation of bulk Argon and Oxygen distribution systems

Amgen

Small-scale Fermentor Upgrades

Replacement of piping, valves, and instrumentation on a 250L fermentation skid to enable CIP/SIP and enhanced operability

Amgen

Small-scale Centrifuge Upgrades

Replacement of all valves and instrumentation on an existing 100L centrifuge to enhance operability

Amgen

Laboratory Space Tenant Improvement and Sublease

Reconfiguration of a pilot-scale fermentation, cell processing and purification suite to enable sublease of space for research laboratory use by a third-party

Amgen

Large-scale UF/DF Skid Implementation

Enlargement of an existing 500L stainless steel concentration vessel in place and installation of a new ultrafiltration/diafiltration skid and controls system

Amgen

Warehouse Fire Protection System Retrofit

Reconfiguration of an existing fire sprinkler system in an existing GMP warehouse space

Amgen

Purified Water and Water for Injection Loop Online TOC Analyzer Integration

Installation of TOC analyzers on PUR and WFI water loops to enable online and real-time release of purified water for use in the process

Amgen

Large-scale Centrifuge Upgrades

Retrofit of an existing Alfa Laval 618 centrifuge, piping module, and controls system to enable use by both microbial and mammalian host processes

Amgen

Process Chiller Replacement

Design and installation of a process chiller to be utilized as a backup to an existing chiller operated in a lead-lag configuration

Amgen

Automated Roller Bottle System Improvements

Implementation of improvements to mechanical and controls systems to handle to transfer and processing of 32,000 1L roller bottles via automated conveyors and rack systems

Amgen

Waste Neutralization System Troubleshooting/Upgrades

Assessment and corrective measures implementation for a centralized system to neutralize pH in laboratory waste drains prior to discharge to the city sanitary sewer

Amgen

Research/Analytical Laboratory Remodel

Reconfiguration of existing analytical lab space to enable more efficient sample receipt and analysis turnaround times

Amgen

Research/Analytical Laboratory Building Tenant Improvements

Assessment of the existing utility and infrastructure in a decommissioned lab building and implementation of improvements to enable use to meet User's needs

Amgen

Clean Room Expansion

Enlargement and reconfiguration of a clean room and gowning room to enable more efficient materials/personnel flow

Amgen

Data Center (Tier III) Construction

Design of multiple active power and cooling distribution paths (one active) with redundant components, and concurrently maintainable to provide 99.982% availability

Amgen

Administration and Laboratory Space Buildout

Buildout of a core and shell space with administrative offices and laboratories

Amgen

Automated Roller Bottle System Improvements (Six Sigma)

Execute DMAIC process (Define, Measure, Analyze, Improve, Control) to improve operability of existing automated system to handle 32,000 roller bottle via conveyors and rack transfer system.

Amgen

Project Execution Process Development

Develop standard processes for Project Management, Project Engineering, Project Controls, Construction Management, and Commissioning/Qualification applicable across multiple sites

Amgen

Project Execution LEAN Process Improvements

Execute LEAN process to improve processes for Project Management, Project Engineering, Project Controls, Construction Management, and Commissioning/Qualification applicable across multiple sites

Amgen

Project Portfolio Management

Development of capital and expense project scopes, budgets, schedules, and business justifications for the entire portfolio of projects

Amgen

New Product Introduction (NPI)

Commercialization of a new product manufacturing capability into an existing production facility including all aspects of engineering and commissioning/qualification as well as regulatory requirements and filing documentation

Amgen

Owner's Rep for Plant Engineering Group

Augment internal Plant Engineering personnel in reviewing 3rd party engineering and validation contractor deliverables in line with Client's goals and expectations.

Amgen

Microbial Process Bioburden Six Sigma Evaluation

Six Sigma analysis of the historical data from two different microbial processes run at the same manufacturing facility to assess if bioburden levels warranted corrective action.  Analysis ended up saving client ~$500K in capital spending to address what was perceived to be an issue.

Amgen

Automation Controls Validation

Comprehensive Installation and Operational Qualification (IQ/OQ) document preparation for the upgrade of a PLC-based control system in a manufacturing facility

Amgen

Microbial Process Scale-up

Process-fit analysis and developed PFDs and project cost estimates for implementation of a new microbial process in an existing facility

Amgen

Cell Culture Process Improvements

Engineering studies to assess baseline conditions of a Cell Culture facility and define problems/corrective actions, business justification for CO2 shakers/incubators, media batch tanks, and fermentor pH controls

Amgen

Actuated Valve Indication Corrective Action

Inventory evaluation of defective valve limit switches and executed a project to replace them concurrent with ongoing operations

Amgen

Spare Parts Assessment and Procurement Support

Technical direction to Facilities/Maintenance department on what spare parts were critical to the processes run at that facility and assisted in procurement of these items

Amgen

Regulatory Compliance Support

Regulatory assessments, compliance program development, documentation preparation and submittal to agencies on Client's behalf

Array Biopharma

API Process Development

Process development and process fit for two injectable API's from laboratory to full-scale production including regulatory documentation development for US and EU filings

Hospira

Air Emissions Permit Assessments

Calculation of VOC, HAP, and criteria pollutants in air emissions from a pharmaceutical production facility and impact evaluation of future production processes

Hospira

Air Permit Application Support

Preparation, negotiation and compliance support for the Air Emissions Permit for a pharmaceutical facility

Hospira

Reverse Osmosis/Deionization (RO/DI) Purified Water System & Loop Installation

Design, construction, commissioning, and startup troubleshooting of a purified water system and distribution loop through a semiconductor manufacturing facility

Maxtor

API Process Engineering/Development

Process research and development from initial concepts through registrations batches for three oncology APIs including PFD/P&ID development, equipment procurement, PHA facilititation, process optimization, and registration batch execution

Mayne Pharma

Hazardous Process Chemical Handling

Design equipment and developed procedures to handle a highly hazardous process raw material including PHA execution and corrective action implementation

Mayne Pharma

API Facility Construction

Design, construction, commissioning, and startup troubleshooting of an $15M API production facility including all process and utility systems

PR Pharmaceuticals

Solvent System Regulatory Compliance Assessment

Design review and PE certification of both fresh and waste solvents systems as required under RCRA including corrective actions for vent control systems

Ribozyme Pharmaceuticals

Acid Vent Scrubber Installation

Design, construction, commissioning and qualification of an acid vent scrubber to remove acid from process equipment vent streams

Roche

API Process Expansion

Design, construction, commissioning, and qualification of a $3M expansion of a peptide process in an existing facility

Roche

Filter Press & Conical Dryer Enhancements

Structural, piping, and electrical modifications to the installation of a filter press and dryer to improve ergonomics and enable use of equipment for potent API compounds

Roche

Hazardous Solids Charging System Installation

Design, construction, commissioning, and qualification of a $500K system to safely handle and charge solids with hazardous characteristics to a processing vessel

Roche

Owner's Rep for Site Capital/Expense Project Execution

Oversight and direction of contractors executing capital and expense projects at a bulk API production facility including progress, cost, and schedule reporting back to Client

Roche

Pharmaceutical Manufacturing Technical Lead

Multiple process-fit evaluations, equipment troubleshooting, change control, process safety, and process quality, yield, cycle time, and throughput optimizations

Roche

Hazardous API Isolation and Drying

Implement innovative technology to centrifuge, dry, and package a highly hazardous and explosive API including initial design through IQ/OQ protocol execution

Roche

Bulk API Solvent Recovery

Implementation of two solvent recovery systems to recover approximately $2.3M per month of solvents using continuous/semi-continuous atmospheric & vacuum distillation units.

Roche

Pharmaceutical Process Tech Transfer

Technology transfer of numerous pharmaceutical processes from lab-scale to pilot-scale to full-scale production facilities

Roche

Process Hazard Analysis (PHA) Facilitation

Development of process safety information packages and PHA leadership for numerous new products being brought into existing and new facilities

Roche

Air Emissions Permit Compliance Evaluations

Calculation of VOC, HAP, and criteria pollutants in air emissions from a pharmaceutical production facility and impact evaluation of future production processes including direct negotiations with regulatory agencies

Roche

Process Vessel Replacement

Replacement of an existing 8000L glass-lined production reactor with a 12000L stainless steel reactor with agitator, heating/cooling bath, piping and instrumentation, and Delta V controls

Roche