| Sample Projects |
cGMP Compliance
cGMP Upgrades, 2003 – Mountain View, CA: 60,000 sf, Upgraded 40 existing
process and production rooms to comply with European regulatory standards. Pilot
and Scale up work was completed on a variety of pharmaceutical products using Oral
Solid Dosage technology. The project consisted of a complete cGMP upgrade to the
building including new AHU’s, EF’s, Gowning Areas, modified personnel and material
flow of control areas, modified air flow and air cascade, differential pressures, and
humidity control. All construction was completed while maintaining zero interruptions
to a fully operational facility.
process and production rooms to comply with European regulatory standards. Pilot
and Scale up work was completed on a variety of pharmaceutical products using Oral
Solid Dosage technology. The project consisted of a complete cGMP upgrade to the
building including new AHU’s, EF’s, Gowning Areas, modified personnel and material
flow of control areas, modified air flow and air cascade, differential pressures, and
humidity control. All construction was completed while maintaining zero interruptions
to a fully operational facility.
Commercial Manufacturing Projects
Commercial Launch Facility, 2001-2002: 42,000 s.f. Clinical and Launch Facilities for
gene therapy based cancer products. Manufacturing technology uses both Perfusion
and Batch cell culture processing. Process areas include Media and Buffer prep, Cell
Culture suites, Initial and Final Purification suites, and sterile filling. Equipment
includes WFI, Lyophilizers’s, Autoclaves, SIP, CIP, Transfer Panels, Filling line and all
site utilities. Scope of work included development of all personnel and material flows,
FDA package development, and overall facility design.
Laboratory Upgrade, 1998: 6,000 s.f. Pilot facilities for manufacture of a leuprolide
acetate implant. This product delivers leuprolide continuously for 12 months for the
treatment of advanced prostate cancer. Facilities include drug compounding, filling,
capping, and labeling.
Commercial Manufacturing Building Upgrades, 1990: 15,000 s.f. Pilot and Scale Up
facilities for manufacture of an ocular drug delivery system which delivers pilocarpine
for the control of elevated intraocular pressure in glaucoma patients. The facilities
included injection molding, form-fill-and seal operations, sterile die cutting, terminal
sterilization, labeling and packaging.
Commercial Manufacturing Facility, 1989: 7,000 s.f. Pilot and Scale Up facilities for
manufacture of a progesterone based product. This product was developed as an
intrauterine contraceptive system for localized delivery of progesterone for one year.
The facilities included injection molding, drug compounding, mixing and blending,
sterile fill operations, labeling and packaging.
Commercial Manufacturing Facility, 1989: 117,000 s.f. Commercial facilities for
manufacture of an oral dosage form using the drug nifedipine and Transdermal dosage
forms using the drugs Nicotine and Clonodine. Facilities included a Pilot Plant for Pre-
Clinical work including mixing, blending, fluid bed granulation, tablet compression,
coating, laser drilling, and labeling. Transdermal area included mixing, blending, film
casting, die cutting, packaging and labeling. Scale up and Commercial facilities
included large scale mixing, blending, fluid bed granulation, tablet compression,
coating, laser drilling, labeling, and packaging.
Commercial Manufacturing Building Upgrade, 1987: 22,000 s.f. Pilot and Scale Up
facilities for manufacture of an ivermectin based veterinary product. This product
delivers ivermectin continuously for approximately 3 months for the control of parasites
in cattle. The facilities for this product include mixing, blending, drug compounding,
fluid bed granulation, tablet compression, filling, capping, labeling, packaging, and
cartoning.
Corporate Headquarters Campus Project, 1996-1997: 180,000 s.f. Development
Labs, Pilot Facilities, and Commercial Launch facilities for development of
Polymerase Chain Reaction (PCR) based diagnostic products. Indications include
Hepatitis C&B, Tuberculosis, HIV- 1, and other infectious diseases. Facilities included
Research Labs, Development and Scale Up facilities including mixing, batch
processing, filling, lyophilizing, labeling and packaging.
gene therapy based cancer products. Manufacturing technology uses both Perfusion
and Batch cell culture processing. Process areas include Media and Buffer prep, Cell
Culture suites, Initial and Final Purification suites, and sterile filling. Equipment
includes WFI, Lyophilizers’s, Autoclaves, SIP, CIP, Transfer Panels, Filling line and all
site utilities. Scope of work included development of all personnel and material flows,
FDA package development, and overall facility design.
Laboratory Upgrade, 1998: 6,000 s.f. Pilot facilities for manufacture of a leuprolide
acetate implant. This product delivers leuprolide continuously for 12 months for the
treatment of advanced prostate cancer. Facilities include drug compounding, filling,
capping, and labeling.
Commercial Manufacturing Building Upgrades, 1990: 15,000 s.f. Pilot and Scale Up
facilities for manufacture of an ocular drug delivery system which delivers pilocarpine
for the control of elevated intraocular pressure in glaucoma patients. The facilities
included injection molding, form-fill-and seal operations, sterile die cutting, terminal
sterilization, labeling and packaging.
Commercial Manufacturing Facility, 1989: 7,000 s.f. Pilot and Scale Up facilities for
manufacture of a progesterone based product. This product was developed as an
intrauterine contraceptive system for localized delivery of progesterone for one year.
The facilities included injection molding, drug compounding, mixing and blending,
sterile fill operations, labeling and packaging.
Commercial Manufacturing Facility, 1989: 117,000 s.f. Commercial facilities for
manufacture of an oral dosage form using the drug nifedipine and Transdermal dosage
forms using the drugs Nicotine and Clonodine. Facilities included a Pilot Plant for Pre-
Clinical work including mixing, blending, fluid bed granulation, tablet compression,
coating, laser drilling, and labeling. Transdermal area included mixing, blending, film
casting, die cutting, packaging and labeling. Scale up and Commercial facilities
included large scale mixing, blending, fluid bed granulation, tablet compression,
coating, laser drilling, labeling, and packaging.
Commercial Manufacturing Building Upgrade, 1987: 22,000 s.f. Pilot and Scale Up
facilities for manufacture of an ivermectin based veterinary product. This product
delivers ivermectin continuously for approximately 3 months for the control of parasites
in cattle. The facilities for this product include mixing, blending, drug compounding,
fluid bed granulation, tablet compression, filling, capping, labeling, packaging, and
cartoning.
Corporate Headquarters Campus Project, 1996-1997: 180,000 s.f. Development
Labs, Pilot Facilities, and Commercial Launch facilities for development of
Polymerase Chain Reaction (PCR) based diagnostic products. Indications include
Hepatitis C&B, Tuberculosis, HIV- 1, and other infectious diseases. Facilities included
Research Labs, Development and Scale Up facilities including mixing, batch
processing, filling, lyophilizing, labeling and packaging.
| Total Project Services Professional cGMP Project Management for the Pharmaceutical Industry |
Aseptic Manufacturing
Aseptic Manufacturing Facility Upgrades, 1995: 21,000 s.f. Pilot facilities for
development of injectable chemotherapy products using a cisplatin gel developed to
be injected directly into tumors. The indications targeted are head and neck cancers
and primary liver cancer. Manufacturing space includes a sterile fill operation,
formulations development, mixing, and compounding.
development of injectable chemotherapy products using a cisplatin gel developed to
be injected directly into tumors. The indications targeted are head and neck cancers
and primary liver cancer. Manufacturing space includes a sterile fill operation,
formulations development, mixing, and compounding.
Biotech Construction Projects
Pilot, Scale-Up, and Clinical facilities for development of antibody therapeutic
products using CHO host cells. Facilities include research labs, Pilot scale and
Clinical scale buildings. Process areas include Cell banking, Media and Buffer
prep, Cell Culture suites, Purification suites, and sterile filling. Equipment
includes WFI, Lyophilizers, Commercial Autoclaves, SIP, CIP, Transfer Panels,
Filling line and all site utilities. Scope of work included development of all
personnel and material flows, FDA package development, and overall facility
design.
Clinical and Launch Facilities for gene therapy based cancer products.
Manufacturing technology uses both Perfusion and Batch cell culture processing.
Process areas include Media and Buffer prep, Cell Culture suites, Initial and Final
Purification suites, and sterile filling. Equipment includes WFI, Lyophilizers’s,
Autoclaves, SIP, CIP, Transfer Panels, Filling line and all site utilities. Scope of
work included development of all personnel and material flows, FDA package
development, and overall facility design.
Development Labs, Pilot Facilities, and Commercial Launch facilities for
development of Polymerase Chain Reaction (PCR) based diagnostic products.
Facilities included Research Labs, Development and Scale Up facilities including
mixing, batch processing, filling, lyophilizing, labeling and packaging.
products using CHO host cells. Facilities include research labs, Pilot scale and
Clinical scale buildings. Process areas include Cell banking, Media and Buffer
prep, Cell Culture suites, Purification suites, and sterile filling. Equipment
includes WFI, Lyophilizers, Commercial Autoclaves, SIP, CIP, Transfer Panels,
Filling line and all site utilities. Scope of work included development of all
personnel and material flows, FDA package development, and overall facility
design.
Clinical and Launch Facilities for gene therapy based cancer products.
Manufacturing technology uses both Perfusion and Batch cell culture processing.
Process areas include Media and Buffer prep, Cell Culture suites, Initial and Final
Purification suites, and sterile filling. Equipment includes WFI, Lyophilizers’s,
Autoclaves, SIP, CIP, Transfer Panels, Filling line and all site utilities. Scope of
work included development of all personnel and material flows, FDA package
development, and overall facility design.
Development Labs, Pilot Facilities, and Commercial Launch facilities for
development of Polymerase Chain Reaction (PCR) based diagnostic products.
Facilities included Research Labs, Development and Scale Up facilities including
mixing, batch processing, filling, lyophilizing, labeling and packaging.
Research & Development Laboratory Projects
Corporate Headquarters Campus Project, 1996-1997: 180,000 s.f. Development
Labs, Pilot Facilities, and Commercial Launch facilities for development of
Polymerase Chain Reaction (PCR) based diagnostic products. Indications include
Hepatitis C&B, Tuberculosis, HIV- 1, and other infectious diseases. Facilities included
Research Labs, Development and Scale Up facilities including mixing, batch
processing, filling, lyophilizing, labeling and packaging.
Labs, Pilot Facilities, and Commercial Launch facilities for development of
Polymerase Chain Reaction (PCR) based diagnostic products. Indications include
Hepatitis C&B, Tuberculosis, HIV- 1, and other infectious diseases. Facilities included
Research Labs, Development and Scale Up facilities including mixing, batch
processing, filling, lyophilizing, labeling and packaging.
Vivarium Projects
Vivarium Upgrade, 2005: 20,000 s.f. Work included remodel of an animal facility to
meet IACUC requirements. Redesigned the HVAC system for the caging rooms to
meet temperature requirements. Redesigned the vivarium to simplify daily operations
and create a segregation of "dirty" and "clean" activities. Upgrades allowed effective
material and personnel flow needed to minimize cross-contamination.
Vivarium Upgrade, 2001: 27,000 s.f. Work included demolition of two floors of an
existing building. Construction included a new R&D laboratory space, animal
vivarium, cage washing area, X-ray, clean storage, and shipping/receiving. Work
integrated new facility equipment and systems with the existing building systems.
meet IACUC requirements. Redesigned the HVAC system for the caging rooms to
meet temperature requirements. Redesigned the vivarium to simplify daily operations
and create a segregation of "dirty" and "clean" activities. Upgrades allowed effective
material and personnel flow needed to minimize cross-contamination.
Vivarium Upgrade, 2001: 27,000 s.f. Work included demolition of two floors of an
existing building. Construction included a new R&D laboratory space, animal
vivarium, cage washing area, X-ray, clean storage, and shipping/receiving. Work
integrated new facility equipment and systems with the existing building systems.
Clinical Development
Clinical Phase III Facility, 2001-2002: 100,000 s.f. Pilot, Scale-Up, and Clinical
facilities for development of antibody therapeutic products using CHO host cells. The
indications include cancer, transplant rejection, cardiovascular disease, and
autoimmune disorders. Facilities include research labs, Pilot scale and Clinical scale
buildings. Process areas include Cell banking, Media and Buffer prep, Cell Culture
suites, Purification suites, and sterile filling. Equipment includes WFI, Lyophilizers,
Commercial Autoclaves, SIP, CIP, Transfer Panels, Filling line and all site utilities.
Scope of work included development of all personnel and material flows, FDA
package development, and overall facility design.
Diagnostic Manufacturing Facility, 2002: 10,000 sf, 1-story, Manufacturing Facility.
Work included the interior demolition of an existing building. A new manufacturing
facility was built within the space and included both Class 100K, and 10K cGMP
spaces, R&D support laboratories, modular construction dispensing area, office
space, and shipping/receiving. Installation of support equipment included a fully
automated WFI still, CIP system, SIP system, and a new clean Air Handler system.
facilities for development of antibody therapeutic products using CHO host cells. The
indications include cancer, transplant rejection, cardiovascular disease, and
autoimmune disorders. Facilities include research labs, Pilot scale and Clinical scale
buildings. Process areas include Cell banking, Media and Buffer prep, Cell Culture
suites, Purification suites, and sterile filling. Equipment includes WFI, Lyophilizers,
Commercial Autoclaves, SIP, CIP, Transfer Panels, Filling line and all site utilities.
Scope of work included development of all personnel and material flows, FDA
package development, and overall facility design.
Diagnostic Manufacturing Facility, 2002: 10,000 sf, 1-story, Manufacturing Facility.
Work included the interior demolition of an existing building. A new manufacturing
facility was built within the space and included both Class 100K, and 10K cGMP
spaces, R&D support laboratories, modular construction dispensing area, office
space, and shipping/receiving. Installation of support equipment included a fully
automated WFI still, CIP system, SIP system, and a new clean Air Handler system.
Commercial Buildings
Commercial Manufacturing Facility, 1989: 117,000 s.f. Commercial facilities for
manufacture of an oral dosage form using the drug nifedipine and Transdermal
dosage forms using the drugs Nicotine and Clonodine. Facilities included a Pilot
Plant for Pre-Clinical work including mixing, blending, fluid bed granulation, tablet
compression, coating, laser drilling, and labeling. Transdermal area included mixing,
blending, film casting, die cutting, packaging and labeling. Scale up and
Commercial facilities included large scale mixing, blending, fluid bed granulation,
tablet compression, coating, laser drilling, labeling, and packaging.
manufacture of an oral dosage form using the drug nifedipine and Transdermal
dosage forms using the drugs Nicotine and Clonodine. Facilities included a Pilot
Plant for Pre-Clinical work including mixing, blending, fluid bed granulation, tablet
compression, coating, laser drilling, and labeling. Transdermal area included mixing,
blending, film casting, die cutting, packaging and labeling. Scale up and
Commercial facilities included large scale mixing, blending, fluid bed granulation,
tablet compression, coating, laser drilling, labeling, and packaging.
Process Equipment Installation
Purification Suite, 2002: 5,000 sf, Purification Suite. An existing modular clean
space was converted to a new Purification Suite. Work included extensive re-work of
the existing space and process piping to accommodate the new equipment. The
project was completed on a design build basis and involved heavy communication
between the end users and the design/build team.
space was converted to a new Purification Suite. Work included extensive re-work of
the existing space and process piping to accommodate the new equipment. The
project was completed on a design build basis and involved heavy communication
between the end users and the design/build team.
- Develop material and energy balances for complete processes and unit
operations - Extensive experience performing scale-up of bench top operations to pilot
plant and then to full production scale processes - Characterize and optimize unit operations by using statistical methods such
as Statistical Process Control and Design of Experiments - Recommended and installed numerous water treatment systems for the
Biotech industry
Professional Office Projects
Corporate Headquarters Campus Project, 1996-1997: 180,000 s.f. Development
Labs, Pilot Facilities, and Commercial Launch facilities for development of
Polymerase Chain Reaction (PCR) based diagnostic products. Indications include
Hepatitis C&B, Tuberculosis, HIV- 1, and other infectious diseases. Facilities included
Research Labs, Development and Scale Up facilities including mixing, batch
processing, filling, lyophilizing, labeling and packaging.
Labs, Pilot Facilities, and Commercial Launch facilities for development of
Polymerase Chain Reaction (PCR) based diagnostic products. Indications include
Hepatitis C&B, Tuberculosis, HIV- 1, and other infectious diseases. Facilities included
Research Labs, Development and Scale Up facilities including mixing, batch
processing, filling, lyophilizing, labeling and packaging.
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