Development of a scalable manufacturing process
How GRA assisted in the development of a scalable purification process for a novel live attenuated viral vaccine for First-in-Man trials.
what we do
Consultancy, Management Expertise & Training
GRA is grounded in the development of Biologics and Advanced Therapies (ATMPs). We cover a broad range of modalities including monoclonal antibodies, ADCs, biosimilars as well as cell-based & gene therapies and all vaccine forms.
We support start-ups to multinational organisations, whether at the bench or on the board, GRA delivers client focused consultancy and management expertise. We perform client training to ensure that you are up to date on the latest regulatory and technical requirements.
Technical Expertise: Our experts provide consulting capabilities to support clinical development through to launch. We have expertise in CMC (manufacturing & analytical), quality (QA), regulatory affairs (RA), pre/non-clinical development, clinical development & monitoring. All activities are supported with experienced project management that ensure timely completion of programme objectives within acceptable risks & agreed budgets to help eliminate costly mistakes and program delays.
Commercial Expertise: We serve on advisory & company boards, frequently conducting investor due diligence. We support clients on commercial aspects of programs. These including market analysis, licensing opportunities, pipeline evaluation, portfolio prioritisation, competition analysis, product pricing and NPV determinations. We can also assist with due diligence activities (inbound and outbound) and even support you with negotiation of agreements, whether commercial licencing or clinical or commercial supply agreements for external production.
Training: Our programmes are specifically tailored to your needs and can be delivered in person or online. We currently have programmes covering CMC including phase appropriate process and analytical development, quality management and regulatory requirements. We specialise in Quality by Design, Design of Experiments and their statistical application to CMC, including process and analytical, including cell based bioassays.
01
CMC & Manufacturing
Process Development, MSAT & Validation. Developing & optimising processes, including using QbD approaches, enabling well controlled & robust processes that can progress to PPQ and commercial launch.
CMC & Manufacturing02
Assays & Quality Control
Analytical & Bioassay Development & Validation. Analytical methods used for product release & stability, including potency assays & product characterisation, are suitably optimised & validated in line with ICH guidance.
Assays & Quality Control03
QA, Auditing & Regulatory Affairs
GxP mandates supplier audits, quality reviews, Quality Management Systems (QMS) & QP release. Regulatory strategy & filing support on biological products for dossier submissions.
QA, Auditing & Regulatory Affairs04
Programme &
CDMO Management
Effective project management of programs from research to launch, combined with efficient management of CDMOs, streamlining the development path to market.
Programme & <br/>CDMO Management05
Strategic Planning & Due Diligence
Supporting due diligence for evaluation of potential business investment decisions and strategic planning of development activities for successful business outcomes.
Strategic Planning & Due Diligence06
Formulation Development
& Stability
Developing formulations alongside accelerated stability & forced degradation studies ensuring the most suitable excipients for maximising product potency & shelf life.
Formulation Development <br/>& Stability07
Preclinical,
Non-clinical & Toxicology
Preclinical & toxicology support for programs progressing to clinical stage studies and requiring mechanism of action and safety support for regulatory submissions.
Preclinical, <br/>Non-clinical & Toxicology08
Clinical Development
& Monitoring
Supporting the management & monitoring of clinical research organisations (CRO) in the execution of client clinical programs including clinical project management.
Clinical Development <br/>& Monitoring
who we are
GRA: The Biotech Consultancy
Experts | Transformative | Agile
GreyRigge Associates (GRA) is a global biotech partner that was founded in 2010. We deliver consultancy, management expertise and training across the entire product development journey. Our extensive biopharmaceutical industry experience and pragmatic, agile approach enables transformational success by accelerating our clients’ medicines to market. GRA has offices in the UK, the USA and Asia-Pacific, providing support worldwide.
Technologies
Services We Provide
- Biotechnologies
- Vaccines
- Cell-based Therapies
- Gene Therapies
Biotechnologies
We have extensive experience working on the development of biopharmaceuticals & ATMPs. We also work on test designs for device development including PoC as well as supporting laboratory instrument optimisation.
the development process
How We Help
1
Preclinical
Translating science into development-ready strategies
Developing proof of concept to support filings
Considering regulatory and CMC up-front
2
Phase I
Establishing regulatory strategies, quality systems & CMC processes
Managing CDMOs for clinical manufacturing & analytics
Ensuring smooth clinical supply for FIH trials
3
Phase II
Optimising processes & assays using QbD
Working with global agencies on regulatory strategies
Ensuring clinical materials are comparable between trials
4
Phase III
Ensuring CMC & quality systems are ready for production
Planning & executing PPQs & assay validation
Supporting late-stage trials & inventory management
5
Commercial
Developing supply chain strategies with regulatory compliance
Supporting product launch & lifecycle management
Navigating global regulatory approvals
the team
Our Associates
Lee Smith
Managing Partner & Director
Lee founded GRA and has a passion for developing medicines and improving lives by helping biotech companies succeed through guiding a product’s development to licensure.
Samantha Dowse
Managing Partner & Director
Sam is a deeply experienced CMC analytical program leader who enjoys building client relationships and taking an adaptive, pragmatic approach to deliver tailored solutions to complex problems.
Andrew M Thomson
Managing Partner & Director
Andrew directs the APAC subsidiary, bringing deep experience in Medical Research and Life Sciences in microbiology, molecular and cellular biology, assay development, process development and CDMO management.
Rod O’Keeffe
Senior CMC Consultant
Extensive experience in the development of biological products across diverse disciplines, including regulatory experience in authoring CMC sections for clinical trials and commercial registrations.
Cora Henwood
Senior CMC Consultant
Cora has over 30 years’ experience in biologics development with specific expertise in downstream process (DSP) development of processes.
Leonardo Sibilio
Senior Process Consultant
Extensive experience in Process Development of mAbs, recombinant proteins, and adenoviral vectors. Expert in GMP Manufacturing up to 2,000 L bioreactor scale as well as providing regulatory support (CMC) for IMPDs and BLAs.
Andrew Thomson
Senior Analytical Consultant
Andrew brings Analytical development, QC consultancy an Analytical support, specialising in biophysical methodology and supports biopharmaceutical clients.
John Little
Senior Analytical Consultant
A Scientific Leader with extensive experience of developing biopharmaceutical and gene therapy products, in the academic, public, and private sectors and through freelance consultancy.
Melody Janssen
Senior Pre-Clinical Consultant
Expert in immunology, immunogenicity and (bio)analytical sciences, across small molecules, biologics, vaccines, drug delivery systems, gene & cellular therapies - GMP, GLP, and GCP, non-clinical, and translational development
Ronan O’Kennedy
Senior Process Consultant
Expert commercial process scientist including biopharmaceutical development and technical transfer, mammalian and microbial cell upstream process development, data analysis and QbD.
Joseph Irwin
Senior Consultant – Regulatory Affairs
Highly experienced Regulatory Professional adept at leading International Regulatory Agency submissions and interactions.
Jean-Marc Wilkin
Senior Consultant - CMC Regulatory
Accomplished senior regulatory professional with over 25 years of experience in research and development of biotechnical products in the pharmaceutical industry, supported by 10 years hands on research work.
Jacqueline Abbas
Senior Consultant - Programme Management
Over 25 years experience in early stage biotech, biopharma and CROs across global programme leadership, clinical development & operations, medical and regulatory affairs from pre-clinical through life-cycle management.
Jim Mills
Associate Consultant
Jim is a bioprocess and biopharmaceutical expert with 30 years of experience. Expertise includes manufacturing technical due diligence, technology assessment and company acquisition technical due diligence.
Alan Savage
Associate Consultant
Alan is an experienced quality professional with over 40 years of experience in the pharmaceutical industry. He specialises in R&D and production facilities
Gary Wilcock
QA professional
BA strategic leader and expert in all aspects of Pharmaceutical CMC and QA, with over 35 years of relevant experience. Proficient in all dosage forms
Irwin Hirsh
Senior Process Consultant
30 year background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. QbD and DSP expert building process-oriented systems within CMC and quality departments.
Warren Roche
Associate Consultant
Consultant Statistician, providing expertise aligned with the latest regulatory guidance. Focus includes shelf-life determination, method and process development, validation and specification setting.
SOTA Kurita
Consultant
Sota-san has >30 years Pharma/Biologics experience as an established CMC professional and consultant. He bridges Language and Regulatory gaps between Japan and rest of the world.
Mike Breese
Senior Quality Consultant (QP)
Mike is an established QA professional with Qualified Person status and extensive experience in the Life Sciences Industry. An interim QP/Auditor for Fisher who has consulted for more than 20 years.
Lori Rinckel
Senior Analytical Consultant
Detail-oriented scientist with 25+ years’ experience with cGMP and GLP regulated products. Expert in development, optimization, qualification, validation, transfer, implementation, testing, and review.
Dina Anderson
Senior Consultant - Programme Management
Deep experience in academia, start-up/biotech, midsize and large Pharma. Excellent communication and track record of project management, scientific leadership, R&D lifecycle delivery and post-marketing initiatives.
Spiros Servos
Commercial Strategy Consultant
Spiros is a biopharmaceutical business expert and deal-maker with over 20 years in biotech. His experience includes partnering, asset disposition, due diligence, technology scouting, business intelligence, valuations & revenue forecasting
Tiffany Rau
Senior CMC Consultant
Nearly 20 years CMC Manufacturing and Strategy experience in mammalian and microbial systems, plus QbD and six sigma black belt.
Steven Erb
Analytical Consultant
Steve has 14 years of industry experience in CMC product development of cell therapies and virus vaccines in analytical development and strategy, quality control, and CMC regulatory affairs at small biotech and big pharma companies.
Testimonial
Reviewed by You
Flugen Inc.
Provided the capability that we needed and provided knowledge-based guidance on developing a manufacturing process that resulted in clinical trial material for our first-in-man trial.
Chief Scientific Officer
Takeda Vaccines Inc.
The experience in the different types of assay development & validation proved very valuable
Director of CMC
Merck Sharp & Dohme GmbH
Working with GRA has many advantages. One example is the extraordinary network of Associates from different scientific areas that GRA has built over the years. This brings specific know-how to exactly where it is needed for only as long it is needed; a very sophisticated approach. A combination of Lee's personal expertise combined with the know-how from the Associates brings project development to the next level
SVP Technical Operations
Themis Bioscience GmbH
We felt that our projects were important to Lee, and see him as a part of the team rather than as a consultant who shares his views and runs away thereafter…
CEO
Inviragen Inc.
Lee is an industry expert with technical knowledge about biologics that extends from research to CMC through to regulatory
Takeda Vaccines Inc.
In a highly regulated environment GRA helped us fully understand the data we're generating and what it actually means
Takeda Vaccines Inc.
I really enjoyed the part of learning statistics and how it can be applied to increase our understanding of processes but not only manufacturing but also analytical.
Head of Analytical Development
Capillary Film Technology Ltd.
All round experience in commercialisation and industrial R&D
Director
Clearbridge Accelerator Pte Ltd.
Very talented & capable with strong leadership skills and business management capabilities
Managing Director
Abcam plc.
It was a pleasure working with you
Manager
Flugen Inc.
Came in with a very strong problem solving attitude from the beginning and struck the right balance of telling us what we didn’t know while respecting that we were not totally ignorant
CEO
ILC Therapeutics Ltd
GRA’s expertise has resulted in significant advances in our drug development pathway. Their specialist CMC knowledge, and experienced approach, is ideally positioned to provide relevant guidance for biotech’s like ILCT.
Chief Operating Officer
Sorriso Pharmaceuticals Inc.
Their level of knowledge, expertise, and ability to function as an extension of our internal CMC staff has contributed significantly to the ability of the CMC group to successfully produce clinical trial material, complete various regulatory filings, and answer detailed regulatory agency CMC questions. Their experience and ability in managing both CMOs and 3rd party service providers has been continually demonstrated and a critical success factor for our lead program. I highly recommend GreyRigge to any life science company looking to engage CMC expertise or supplement internal CMC capabilities.
COO
Epsilogen Ltd
During Epsilogen’s CMC campaign for our lead product MOv18 IgE, the first ever IgE antibody therapeutic to enter clinical testing, we brought on board GRA to provide client analytical expertise. GRA worked closely, both with Epsilogen and our CDMO, Lonza, and their knowledge and expertise as well as their commitment and diligence to the project was critical to the success of the campaign. They embedded quickly and seamlessly into the team and ensured that Epsilogen had a clear understanding of the more complex antibody characterization studies
VP Product Development
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