Atul Pabalkar, Sr GM Engineering and Projects of Biopharmax, recalls the journey of Biopharmax and talks about its increasing global presence
Mission: Design, build and validate, tailor made biopharmaceutical manufacturing facilities.
The company was established in 1978, with a unique design build, turnkey approach and timely delivery of custom manufacturing solutions. Since 1998, Biopharmax deepened its capabilities in biotechnology manufacturing technologies.
Biopharmax, a global design and construction provider of manufacturing facilities and systems for biotechnology, and pharmaceutical manufacturers, has experience to cater industry leaders around the world. The company’s turnkey execution assures its clients a high-end production facility completed on time.
In order to enhance this expertise, Biopharmax India arm was established in 2006, which now forms the core design part of Biopharmax group. Biopharmax’s in-house team of engineers has years of experience in each discipline involved in the design, construction and validation of the facility. The team has been able to identify the regulatory challenges from a very early stage, and accordingly offers an optimal solution based on its diverse industry experience.
Biopharmax is dedicated to design and execution of biotechnological, API and pharma manufacturing facilities. Biopharmaceutical unique manufacturing processes require specialised tailor-made solutions with dedicated know-how and industry experience.
In order to support manufacturing process integrity, repeatability and compliance with global and local cGMP requirements, Biopharmax developed state-of-the-art design methods and tools for lean and efficient manufacturing facilities.
The company is committed to maintain strictest standards and to comply with latest cGMP requirement per global and local authorities (FDA, EMEA, SFDA, Indian cGMP, local MoH etc.).
One stop shop solutions
It is uncommon in the Biopharmaceutical industry to find a partner that commits to:
- Design to supply, commissioning and qualification
- Conceptual, basic and detail engineering
- Process skids and system expertise- CIP/SIP, fermentation, PW/WFI
- cGMP gap analysis and gap closure
- Project management consultancy (PMC) services
- Project execution
- Technology sourcing
Products and services
Design to validation
Design to validation with four decades of industry experience and hundreds of successes, Biopharmax has positioned itself as one of the world leaders in design and validation of biopharma facilities.
By utilising its in-house capabilities, Biopharmax provides the complete design and validation range to comply with manufacturing facility requirements.
The company’s global staff includes seasoned designers with unique experience in the biopharma industry. New recruits are chosen from the best technical schools and trained by Biopharmax training department, based on programmes developed relying on experience derived from hundreds of projects successes.
While performing the design tasks, the latest design tools are utilised and highest engineering standards are maintained.
Biopharmax is committed to comply with cGMP as required by the various regulatory authorities, both local and FDA/ EMEA.
Plants and systems
Biopharmax core competency is to design, build and validate cutting-edge, cost- effective biopharmaceutical manufacturing facilities. The company’s experience and solution range includes manufacturing facilities for biotechnology, API and formulation.
In the last four decades, the company has created and improved manufacturing technologies and tailor-made solutions to cover manufacturing facilities entire requirements and to comply with the industry standards evolution.
The company caters to its clients with all scales of manufacturing, including commercial scale, pilot and R&D, designed and built on greenfield sites or within an existing envelope. Client’s facilities are upgraded to increase capacities, improve cGMP level, and automate production or other plant modifications as required.
Biotechnology is a highly specialised segment within the biopharma space. In recent years, biotechnology has evolved which has lead the industry manufacture medicines as biosimilar to become more accessible for patients globally.
The challenge of modifying the manufacturing processes, optimising and scaling them up, and finally implementing into commercial scale manufacturing – requires years of experience and in-depth specialised know how.
Biopharmax accumulated unmatched experience and high level of expertise since many years. It has pioneered in cost effective manufacturing facilities design and implementation.
Biopharmax experience includes biotechnology facilities, which manufactures therapeutics products, with all common manufacturing technologies – fermentation, mammalian, bacterial, blood fractionation, plant cells and others.
By utilising Biopharmax generic experience, the company has been able to design, even in the most complex biotechnology projects, compact design with linear process flow to enable operational excellence and competitive advantage.
Products include mammalian and bacterial proteins, monoclonal antibodies, blood derivatives, transgenic and other administered as parenteral, enteral or topical.
Biopuremax: The next generation of pharma pretreatment water system
Biopuremax is the ultimate pure water system solution. It is an environmental friendly, clean, simple, reliable and effective way of supplying chemical free hardness reduced water for use as RO feed water without the need of any additional treatment. The Electrolytic Scale Reduction (ESR) process is an elegant solution that replaces both ion exchange softeners and antiscalant chemicals. An electric field generates a high pH near the cathode which deposits scale in the reaction chamber and releases CO2.
The system has no moving parts, no regeneration requirement and no media that may incubate biogrowth. Furthermore, municipal feed water is commonly treated with a sanitisation agent that damages delicate RO membranes or CEDI resin. This oxidizer is removed by the high-powered ultraviolet lamp – the BioPuremax HOD unit. The HOD unit is an electromagnetic radiation device that uses no additional substance. As with the EHR unit, the HOD unit has no moving parts, no regeneration requirement and its SS 316L smooth clean pipe construction has no media that may trap incoming contamination and incubate biogrowth. Continuous, complete hot water sanitisation capability gives Biopuremax system a unique advantage: the removal of all biofilm and viable organisms through an 80°-90°C hot water cycle. As part of its all-in-one standard comprehensive service, Biopuremax surveys the customer’s requirements, performs dimensioning and fabrication, provides FAT, on-site installation, SAT and IQ-OQ validation and documentation.