- info-gsls@greenstafflifesciences.com
- Mon - Fri: 9.00 - 18.00 (JST)
- Accessibility
What We Offer
Our Solutions
Greenstaff Life Sciences team unites recruitment specialists and bilingual professionals adept in Research, Development and CMC domains. Our solutions, ranging from executive search to flexible contracting, are finely tuned to diverse requirements.
Introduction
Utilization of New Era Medical Technology & Human Resources
In recent years, various new medical technologies have been emerging worldwide, and scientific advancements in diagnosis and treatment continue to make significant progress. However, there is still ample room for significant breakthroughs. In Japan as well, numerous bio ventures and medtech companies are boldly taking on the challenge of advancing technology further, receiving investments from venture capital, investment banks, AMED, and other sources.
In the fields of diseases such as cancer, mental disorders, Alzheimer’s, autoimmune diseases, and rare diseases where treatment is challenging, the development and approval of safer and more effective new drugs and medical devices are eagerly anticipated by patients around the world.
The evolution of foundational technologies such as AI, bioinformatics, and NGS, along with the profound understanding of advanced biology and genetics, are becoming clear guides for companies aiming to identify such diseases at an early stage, provide personalized treatments for individual patients, and strive for complete recovery.
+
Monthly New Register
+
Happy Clients
+
Active Jobs
We, Greenstaff Life Sciences Division, have inherited the genetic makeup of ICG Medical, a UK-based healthcare company that has been dedicated to better patient care for 18 years. Under our new brand, we aim to develop and launch “unprecedented medical technologies” and support the talent search, team building, and global expansion of life science companies pursuing this mission.
Creating something new requires not only the core technology but also the acquisition of talent with fresh insights, experiences, and talents. Nowadays, the utilization of such talent comes in various forms, including not only full-time employees but also contract workers, dispatch workers, advisors, directors, outsourcing, and external consultants. The Greenstaff Life Sciences Division will offer proposals for these diverse options of talent utilization and provide tailored solutions for companies, not only in Japan but also around the world.
Your Partner for Elevating Life Science Talent & Consultancy
Greenstaff Life Sciences team unites recruitment specialists and bilingual professionals adept inResearch, Development and CMC domains. Our solutions, ranging from outsourcing to flexible staffing, are finely tuned to diverse requirements. Committed to advancing cellular and genetic therapies, we invite you to join us in this journey toward progress today!
Advancing Global Medical Technologies
Cell & Gene Therapies at the Forefront
Research & Development
Research and development (R&D) are critically important in the process of making new drugs. R&D drives innovation in the pharmaceutical industry. It allows pharmaceutical companies to explore novel approaches, discover new compounds, and develop cutting-edge technologies. This innovation is essential for creating more effective and safer drugs for patients. By providing new treatments and therapies that improve and extend the lives of individuals, R&D benefits public health. R&D is also crucial for the long-term sustainability of pharmaceutical companies as well. It enables them to maintain a good pipeline of new products, replacing older drugs as they go off-patent and ensuring the company’s continued success.
- Clinical trials are essential parts of drug development. It involves several phases of testing in human subjects and these trials provide critical data on a drug's safety, efficacy, dosing, and side effects. R&D helps design and conduct these trials.
- Getting Regulatory Approval is a huge milestone of R&D because it means all the investment and efforts made in R&D will be rewarded and the drug companies can mass-produce the drugs and start selling to the hospitals. Regulatory agencies, such as PMDA, FDA, and EMA require extensive data to approve a new drug. R&D ensures that comprehensive and well-documented information is available to meet these requirements.
Over the recent period, several innovative therapies spanning gene, cell, and RNA therapies have gained regulatory approval, ushering in groundbreaking treatments for various medical conditions. Notably, among these approvals are the first-ever treatments for Duchenne muscular dystrophy and dystrophic epidermyolysis bullosa.
Here are some trends in the recent research and development in CGT space
Stem Cell Therapies
Stem Cell Therapies: Stem cell-based therapies were gaining momentum, especially in regenerative medicine. Researchers were exploring the use of induced pluripotent stem cells (iPSCs) and other stem cell types for a wide range of applications, from tissue regeneration to disease modeling. The prospects of stem cell therapy are that the ability to repair or replace damaged tissues and organs, such as the heart, liver, or kidneys. It also has the potential to develop new treatments for currently incurable neurological diseases, such as Parkinson's Disease and Multiple Sclerosis.
Gene Silencing Techniques in Therapeutics
Beyond gene editing, gene silencing techniques like RNA interference (RNAi) were being investigated for therapeutic purposes. RNAi results in temporary silencing of gene expression (knock-down) but CRISPR/Cas system results in permanent gene silencing (knock-out) making permanent changes to the genome. Both of this loss of function technology has their own advantages and limitations in making new drugs.
Personalized Medicine
The concept of personalized medicine was increasingly important. Researchers were exploring ways to tailor cell and gene therapies to the unique genetic and molecular profiles of individual patients. Personalized medicine is beginning to overcome the limitations of traditional medicine. Increasingly, it is allowing health care providers to shift the emphasis in medicine from reaction to prevention.
More cell and gene therapies were entering clinical trials, covering a wider range of diseases and medical conditions. This reflected growing interest from both academia and the pharmaceutical industry. Regulatory agencies were adapting to the unique challenges and opportunities presented by cell and gene therapy. There were efforts to streamline the regulatory process while ensuring the safety and efficacy of these therapies.
CMC
CMC, which stands for Chemistry, Manufacturing, and Controls, is a critical aspect of drug development and regulatory approval. It covers a series of activities and documentation related to the chemistry and manufacturing processes of a pharmaceutical product. CMC is as critical as R&D in making new drugs because it ensures that the drug is manufactured consistently, with high quality, and in compliance with regulatory standards. This ensures patient safety, efficacy, and the ability to bring the drug to market. Failure to address CMC requirements effectively can lead to delays in drug approvals or in some cases, the denial of marketing authorization.
- Regulatory agencies, such as PMDA, FDA, and EMA require thorough CMC data and documentation as part of the drug approval process. Demonstrating compliance with CMC guidelines is crucial to obtain marketing approval.
- Successful CMC work ensures that the drug product is consistently manufactured from batch to batch. This is vital to ensure that each dose of the drug has the same quality, safety, and efficacy, which is a fundamental requirement for patient safety.
- CMC is an important part of quality assurance, such as establishing specifications for raw materials, intermediates, and the final drug product, help maintain the quality and purity of the drug. Quality assurance measures reduce the risk of contamination and ensure the product meets defined quality standards.
- CMC involves process validation to confirm that the manufacturing process consistently produces a drug that meets its specifications. This validation helps identify and address potential manufacturing issues.
- CMC establishes procedures for managing changes in the manufacturing process or product formulation. Any changes must be thoroughly documented and evaluated for their potential impact on product quality and safety.
- Proper CMC planning and execution can help streamline the drug development process and reduce manufacturing and quality control costs in the long run. It can also prevent costly recalls or manufacturing shutdowns due to quality issues.
- CMC compliance is not only essential for approval in one market but also for accessing global markets. Different regulatory authorities around the world require adherence to CMC standards, making it a key factor in international drug distribution.
There is a trend toward optimizing and simplifying the manufacturing processes for cell and gene therapies. This includes reducing the cost and complexity of production to increase scalability and accessibility. Ensuring a secure and efficient supply chain for these therapies has been on-going challenge, this includes issues related to sourcing raw materials, distribution, and the management of complex logistics associated with personalized medicine. As cell and gene therapies move from clinical trials to commercial production, scalability is a significant challenge as well. Developing methods that can scale up production while maintaining product consistency is a key.
Here are some challenges and trends in the recent CMC in CGT space
- The regulatory landscape for cell and gene therapies has been evolving. Regulatory agencies, such as PMDA, FDA, and EMA are working on guidelines and policies to ensure the safety and efficacy of these treatments. Compliance with regulatory requirements was a critical focus for the industry.
- Advanced analytics, including the use of artificial intelligence and machine learning, were being employed for quality control and process monitoring. Ensuring the consistency and quality of these therapies is crucial.
- Companies were exploring novel manufacturing technologies, such as bioreactors and closed systems, to improve the efficiency of production and reduce contamination risks.
- Many companies were forming partnerships and collaborations with contract development and manufacturing organizations (CDMOs) to leverage their expertise in CMC and meet the growing demand for cell and gene therapies.
CMC plays a critical role in cell and gene therapy by ensuring the quality, safety, and consistency of these advanced therapies. Given their unique characteristics, CMC is even more essential in this field to meet the regulatory requirements, ensure patient safety, and optimize the manufacturing processes for these innovative treatments.