Technology Transfer
Technology Transfer
Technology Transfer: From the Laboratory to the Marketplace
In the changing world of drug discovery and development, a new drug entity sits in a laboratory that may someday lead to saving human lives.But without the essential tie of technology transfer, the life-saving invention may never reach the suffering patients. Technology transfer isn’t just a bureaucratic box to tick — it is what converts scientific breakthroughs into actual healthcare solutions by connecting research institutes with manufacturing, and eventually, the global market.
What is the Technology Transfer?
Technology transfer is the sharing of scientific results, methods, or know-how between two or more organizations. In Pharma, it is the movement of a drug product process under development from a laboratory scale to an industrial scale or from one site to another. A large number of companies hire specialized technology transfer providers to handle this complicated process efficiently and in compliance with the regulatory requirements.
Process of Technology Transfer
The technology transfer process usually involves some defined stages:
- Implementation Phase: This includes detecting the need for transfer and holding the technology transfer team, consisting of quality assurance, regulatory affairs, production, and technical personnel from both the sender and receiver units.
- Planning Stage: The preparation of a detailed technology transfer protocol that specifies the goals, scope, duties, schedules, and acceptance criteria is considered the guiding principle for the whole transfer work.
- Knowledge Transfer: Provide training, technical documentation, and awareness of the manufacturing process and critical quality attributes.
- Process Validation: Running process validation at the (new) site to prove a sustained process that meets specification.
- Documentation and Closure: Prepare full documentation, including transfer report, batch records, and analytical results for regulatory compliance.
Benefits of Technology Transfer
The advantages of technology transfer far exceed those for the pharmaceutical company and extend to the whole healthcare system. The gains from technology transfer ripple through society, increasing access for patients to lower-cost medicines, fostering the development of local pharmaceutical manufacturing capacity, and strengthening innovation ecosystems.
Importance of Technology Transfer in the Pharmaceutical Industry
The importance of technology transfer in the pharmaceutical industry is huge. It enables:
➡️ Global Access to Medicine: Production of the drugs that save human lives at multiple sites to improve availability and affordability.
➡️Manufacture Efficiently: Transfer process to site with better facilities or lower cost.
➡️Innovation Power: Allowing research institutions to focus on discovery, while production partners manage scale-up.
➡️Compliance: It meets international standards in the manufacturing of drugs and quality control.
➡️Risk Management: Mitigate risk by establishing a second manufacturing site for supply continuity in case of disruption.
Technology Transfer Agencies in India
India has become the pharmaceutical manufacturing hub of the world, with a number of technology transfer agencies in India. National Level Technology Transfer – The National Research Development Corporation (NRDC), an arm of the government under the Department of Scientific and Industrial Research, facilitates technology transfers from labs to industries. The Council of Scientific and Industrial Research (CSIR) promotes technology commercialization in pharmaceuticals and chemicals through its network of laboratories.
Legal Framework Governing Technology Transfer in India
☑️ Patents Act, 1970: The Patents Act, 1970, is the foundation for technology transfer in the pharmaceutical industry as it extends patent protection to pharmaceutical inventions and includes provisions for compulsory licensing in the public interest.
☑️ Drugs and Cosmetics Act, 1940: The Act controls the import, manufacture, distribution, and sale of drugs by having standards associated with quality for drugs, and such standards should be adhered to during technology transfer.
☑️ Foreign Exchange Management Act, 1999 (FEMA): FEMA also deals with technology transfer, more so in the area of payment of royalties and cross-border intellectual property transactions, for non-residents.
☑️Competition Act, 2002: The act provides that the technology transfer agreement shall not lead to an appreciable adverse effect on competition or result in an abuse of dominant position in the relevant market of the pharmaceutical market.
Our Team Approach
Effective technology transfer is a collective activity involving a multi-disciplinary team working. We are a group of passionate professionals who work together to deliver a full suite of services:
Industry-Leading Experienced Lawyers: Our Lawyers have extensive experience in pharmaceutical intellectual property, regulatory compliance, and contract law.
Technical Advisors: We also have technical advisors who are pharmaceutical manufacturers to help you through the challenges of manufacturing, GMPs.
IP Strategists: Our IP experts focus on your innovation through strategic patent management and licensing solutions.
How Can We Help You on Your Technology Transfer Journey?
We understand that technology transfer protocols are closely scrutinized legally. Our general technology transfer consulting and legal services are designed to protect your interests in all phases of the technology transfer lifecycle. We provide comprehensive technology transfer services that deliver world-class legal and practical expertise in the industry.
- IP Management: We conduct all types of IP management, such as IP audits, licensing negotiations, and strong protection of your company’s proprietary technologies during the path of transfer process.
- Technology Transfer Consulting: Our consultants work with your technical and quality staff to develop an integrated transfer plan and transfer management approach, identify risk, and establish methodologies for the smooth transfer of know-how/process confirmation.
- Compliance: Our specialists will facilitate your technology transfer with Indian and international regulations, including FDA, WHO GMP Guidelines, Indian drug laws etc.
- Contract Negotiation and Representation : We represent and negotiate excellent technology transfer agreements that clearly define the roles, confidentiality issues, quality control descriptions, and methods for dispute resolution.
Why Choose Us?
Our technology transfer consulting methodology is tailored, and we put our clients, you, at the centre of our focus. We are your technology transfer strategic partner, not your legal advisor, and we will work to align your technology transfer efforts with your business goals, yet still hold the highest standards of legal compliance.
Our comprehensive technology transfer solutions have powered the success of many pharmaceutical companies, research organizations, and biotech startups, allowing them to transition smoothly, protect their intellectual assets, and deliver their products to the market more quickly.
Conclusion
Technology transfer is the critical path from drug development to making drugs available to patients. What is Technology Transfer in the Pharmaceutical Industry Information is Value What is technology transfer in pharmaceuticals – a brief overview Incorporate technology transfer in pharma with adequate legal protection is the best advice for pharmaceutical companies now who want to improve on manufacturing processes or for bring an innovative product to the market.
Frequently Asked Question
Depending on the complexity, the duration may be from 6 to 18 months. Simple preparations might be faster, but complicated biologics need more time.
An overall protocol may comprise objectives and scope – roles and responsibilities, process-specific details, critical quality attributes, acceptance criteria, analytical methodologies, and risk management.
Licensing agreements protect the IP by defining the rights of use, territorial restrictions, royalty payments, and confidentiality arrangements, to name a few.
Yes, from the Central Drugs Standard Control Organization (CDSCO) for pharmaceutical technology transfer in India.
The most relevant documentation is the Product Development Record, as well as the method specifications, the equipment specifications, stability information, and the process validation reports.