We have undertaken and successfully completed projects on turnkey basis, where in we cover:

• Technology development - From Literature Survey through R&D to Pilot trials.
• Sequencing and configuring major infrastructure requirements
• Facility Designing
• Utilities - Requirements and Balancing
• AHU design as per Pharma / Biotech concepts
• Liaise with Architects and engineers
• Deciding on process equipment configuration
• Identifying vendors and assessment
• Procurement of process equipment including scheduling deliveries
• Recruitment of technical staff at senior and middle management cadre
• Co-ordinate and be a part of FAT of process equipment
• Laboratory design
• Housing lab equipment - IPQC and QC
• Coordination with all parties involved in the entire project
• Logistic support for various activities including shipment of equipment
• Assistance and support for deciding on Validation Master Plan
• Commissioning of equipment
• Technology transfer and trials
• Setting up procedures for process and QC
• Initial production scale batch

With our technical expertise and our valuable asset - our team, we harmoniously blend with various agencies and work hand-in-glove to keep the project on time and cost-effective..
Being experienced in the multi-faceted activities of Pharma and Biotech and with success stories of turnkey projects completed overseas, we are glad to state that Bioasset Technologies Pvt. Ltd. has been a single point provider and coordinator to our esteemed clients.

By conceiving your project in its entirety, encompassing the technology, process blocks, process sequence optimization, equipment determination and many other factors, we arrive at a facility layout. This conceptual designing helps in accurate analysis of the various aspects like consumption, production, etc. giving an entire picture during the planning stages.

The regulatory requirements within the pharmaceutical and biotechnology industry have become exacting. The GMP regulations are carefully analyzed. This in turn affects the total layout plant of the plant under consideration.
General Outline is as follows:
• Facility design for upstream activities (biopharma)
• Facility for Downstream Processing (biopharma)
• Production layouts with airlock entries
• Area segregation
• Stores and logistics
• Utilities
• Clean Room Technology
• GMP norms for Biologicals / Pharmaceuticals.
• Space allocation equipment-wise and activity-wise
• Utility lines inside various sections.
• Drainage system and kill-tank
• Process Water management
• Security controls - access and CCTVs.
• Type of flooring
• Compliance issues
• Man-movement
• Material Movement
• Unidirectional flow of process sequence
• Process automation
• Laboratory design
• Lab furniture layout
• Building Management system
• Central Data Management

Clean Room Technology is a critical aspect for a Pharmaceutical or Biotechnology facility. Elements contributing to a Clean Room are crucial to be considered right from conceptual stage a new set up.

Classified areas, air locks, pressure differentials go hand-in-hand with humidity, microbial load, temperature, in your facility. These issues are product and process dependant. Designing, fabrication and construction, installation and qualification of theses area all fall under one single aspect of Clean Room Facility and we provide these solutions.

We design, supply and install complete clean room sandwich panels for Pharmaceutical, Biotechnology and Nutraceutical facilities. The panels used are dependent on the type of facility and the budget ranging from thick laminate panels to SS ones.

Walk-on false ceilings, boxing or coving, double glass windows with silicone sealant is included in the design. The design takes into account electrical and communication cables and cutouts for housing switches and sockets, which are flushed with the panel. Likewise, cutouts for grills of the AHU on the panel ceiling and complimentary return risers are also taken into account.

Our wall systems interface smoothly with floors, ceilings, and mechanical components to provide an ultra-clean environment with effective control of Airflow, Pressure, Temperature, Humidity, and Filtration.

All design is structured to fit to the needs of your individual project.

We provide rugged and reliable technologies for Active Pharmaceutical Ingredients, Pharmaceutical products, biologicals and recombinant proteins. The process is standardized, with guaranteed yields and purity. The technologies are commercial ready-to-go and with proven track record.

Having the knowledge and experience in these technologies, we are able to suggest, guide, take you through the technology transfer process and further assist you in technology implementation if desired.

Some of the salient features of the technologies that we offer are:
• Wide range of products
• High yielding cultures.
• Cost effective purification process
• Training at technology provider's facility abroad
• High purity to meet Pharma grades
• Technical back-up
• Support for implementation.

Some of the rDNA Technologies that we offer are:

Interferon Alpha 2a & 2b, Interferon Beta, Interleukins, G-CSF, GM-CSF, EGF, HGH, EPO, Insulin and many others.

Some of the API through fermentation technologies are:

1. Cyclosporin A,
2. Clavulanic acid,
3. Erythromycin,
4. Hyaluronic acid (HA),
5. Vancomycin,
6. Lovastatin,
7. Rapamycin,
8. Natamycin,
9. Itaconic Acid,
10. Shikimic Acid,
11. Vitamin B12,
12. Glutathione,
13. Carotin,
14. Xanthan .
and many more…………..

We design and manufacture modular Laboratory furniture to suit specific needs of a particular laboratory. We use AutoCAD to arrange the lab furniture to best suit the technical and regulatory requirements.
The table type may be full cabinet construction or MS pedestal frames and powder coated MS or SS storage units, depending on customers requirement.

The tabletops have an option of melamine, SS, Granite or special acid resistant ceramic. Electrical trunking with bus-bar arrangements are also provided along with on-line ventilation system.

The lab furniture also covers special cabinets with insulation and double doors and alarms for storing volatile and corrosive chemicals. We also provide fume-hoods with appropriate configuration to suit customers' requirements.

Various models include working table; analytical tables, anti-vibration table, wall storage unit, island benches, etc. are available. We have a string production line up which ensures good quality and timely delivery. Our expertise team of technicians does the installation with proper leveling.
We also expertise in making tailor made design, where we can match the existing furniture if desired.

An optimized laboratory is conceived for you based on four basic parameters viz. the activities envisaged in the laboratory by you, the regulatory standards, the concerned authorities and finally the various disciplines involved in actual laboratory realization process.

We integrate the above and work out an optimized design solution. This can be followed by execution of the plan up to setting up the entire laboratory facility including equipment.

Our aim is to focus on cost effectiveness, optimum functioning and a laboratory environment which promotes a team work concept even though the fields may be interdisciplinary.

The other issues taken into account by us are the maintenance and sanitization to prevent, control and monitor cross-contamination.

We suggest and source equipment if so desired. The types of equipment depend on the set-up and also your specific requirements. The equipment may range from basic and stand alone models to high-end ones, with GMP compliance, 21CFR part11 compliance with on-line data acquisition and monitoring etc.
To sum up:
• We design labs as per GLP norms
• We design R&D, Pilot or Q.C labs.
• We undertake revamping work for existing labs.
• We undertake sourcing and housing appropriate equipment.
• We design and supply lab furniture.
We provide consultancy services for lab management for SOPs, Record Formats, Validation issues etc.

Lyophilizer for industries is a complete automated SCADA system using an OPTO 22 Programmable logic controller. We offer units to comply the GMP guidelines and to meet FDA and other regulatory agency requirements. SIP and CIP units available.

Condenser Capacity : 20 to 800 Kg

SALIENT FEATURES:

Automated cycles for:
• 8 steps of drying and 16 steps of primary drying, one secondary and one final.
• Defrost by warm water/hot gas/steam.
• Sterilization of units designed with steam in place.
• System testing for performance evaluation of the freeze drying cycle.
• Leak rate testing of the entire vacuum system.
• Clean in place when that option is installed.
Some of the technical specifications are :
Shelf areas ranging from 3 to 320 sq. ft./ 0.3 to 30 sq. m, Type - Bulk / Hydraulic stoppering, Temperature below -60 to 70°C, Capacity 12 to 800 Kg, Temperature below -75°C, Vacuum Pump-leybold Two – Stage corrosion resistant, Pump down less than 20 minutes to 100 Torr, Ultimate Vacuum 5 m Torr, refrigeration -compressor Carlyel or Bitser Two – Stage 7.5 to 30 HP , SIP, CIP, Validation Services, SCADA controls, etc.

Innovatively designed Fermenter for pilot and production level is suitable for cultivation of microbial, recombinant, and other cell culture systems on large scale.

Customized integrated packages include sterilization / dosing vessels for large production requirements.

PILOT FERMENTOR

All general features characteristic of standard Fermenter are incorporated and in addition, customized to suit specific requirements. The complete system is skid mounted - vessel with pipe rack & panel.

Optional Features

Automatic in-place sterilization of the vessel, process piping & filters.

Automated CIP
Automatic pressure control
Provision for Independent sterilization of inlet & exhaust filter
Rupture disk
Caster wheels to convert the system as mobile fermenter for convenience in cleaning & maintenance.
Additional ports for convenient access & effective cleaning of the vessel internals are provided for 500 litres and above.


PRODUCTION LEVEL FERMENTOR

Packaged System (up to 20,000 Liters)
Customized integrated packages include sterilization / dosing vessels for large production requirements.

Salient Features:
• Optimally designed for a bank of fermenters in - place
• In place sterilisable transfer lines for the complete system
• Common control system with software interface for data acquisition and supervisory control.

With over two decades of experience in the bio-pharma segment, we cater to the diverse requirements of the complex biotechnology and pharmaceutical world.
Whether you want a project consultant, facility designer, research solution, pilot trials, or outsource your manufacturing, or give the project management on turnkey basis, we are capable of delivering the necessary services - ranging from individual parts of a project to turnkey solutions and from R & D to Production.

We take your product into consideration and work out defined process activities and related equipment. We take you through a dry-run of the process to give you a feel of how the process would be and what are the various aspects that need to be addressed.

With detailed knowledge of the process requirements and GMP / GLP regulations, we design the process area layout for you. Thus, we integrate, balance and optimize on all the relevant issues to provide you a suitable practical, scientific and cost effective solution.

Non-pharmacopoeia molecule evaluation:

Research Programs undertaken in Biotechnology and Pharmaceutical companies include looking out for innovative products or modifying the existing ones for better properties and spectrum. Such New Chemical Entities (NCEs) or products require to prove their efficacy microbiologically in addition to physico-chemical test. In fact, most of the time, the crucial and deciding evaluations are microbiological.

We have the required expertise to design and conduct these difficult evaluations and provide experimental evidence on their performance. Some of the studies that we have conducted are on lactic acid bacteria, anti-fungal compounds, anti-bacterial compounds, screening for spectrum of bactericidal agents, microbiological response for special rDNA protein, designing biological assays, etc.

Microbiological Investigations:

Having expertise in the sterile dosage requirements of pharmaceutical and biotechnology facilities and understanding the low bioburden requirement in Nutraceutical production facilities, we offer consultancy services on the following aspects:
• To find out reasons for Media Fill Failures.
• To find out reasons for Product Failures.
• Handle and investigate market complaint of microbiological nature.
• Finding contamination source and suggest corrective measures.
• To address failure to comply with Environmental Monitoring program.
• identifying the type of contamination and tackling the same.
We also undertake and provide Pharmaceutical Microbiological Testing and Biotechnological Testing.

For any organization, the main concern about a new project is its commercial feasibility. Before embarking on the actual project work, it is advisable for you to understand the technical and financial implications. To provide this insight, we undertake generating a Project Feasibility Report, which covers:
Product Information
Literature survey is conducted to find the:

• Applications and uses
• Mode of action
• Category: Nutritional support/ Biotechnology based or Pharmaceutical - prophylactic or therapeutic.
Existing Players
It is very important to know the product details in its already existing forms:

• Sales / Pricing / Pack size
• Bulk / formulation
• About the product
• Type of packaging
• Stability
Market Research
It is useful to know the scope of the product under consideration, whether it is meant for domestic market or for overseas market. The current trends and future potential are decisive factors to be understood prior to starting a project. We include this in our report.

Technology
Basic technical information is vital, which gives you the background about the project:
• Source of product
• Process
• Downstream processing
• QA/QC
Equipment And Infrastructure
Depending on the process and scale of operation, a general list of equipment with a ball-park estimate of cost is worked out.
Process Equipment
• Water/steam and other such utilities
• Electricity
• Raw material / source
Regulatory Issues
• Possible registrations required
• Authorities involved
• Regulatory clearances before launch of product like toxicology, clinical trials, etc.
• GMP requirements.