At Koncis, we offer strategic and technical Chemistry, Manufacturing, and Control (CMC) consulting services, designed to support the specific needs of the biopharmaceutical and biotech industries. Drawing on more than 25 years of experience, we assist our clients in managing the complexities of biologics development and advancing their projects through all stages of product development and commercialization.
1.
GMP manufacturing & compliance
With over 20 years of experience in medium- to large-scale biopharmaceutical manufacturing, Koncis provides expert support in tackling challenges related to GMP manufacturing and regulatory compliance.
Typical areas of support:
Technology Transfers
Both internal and external.
Facility Fit Assessments
Evaluating how well new processes integrate into existing facilities. Recommendations may involve facility modifications or process adaptations.
Gap Analyses
Benchmarking current processes and infrastructure against the latest regulatory guidelines.
Project Management
Experience the fusion of imagination and expertise with Études Architectural Solutions.
2.
Technical guidance and strategies
A robust strategic approach is key to success in biopharmaceutical development. Koncis offers deep expertise in the CMC domain, ensuring that technical activities are executed appropriately and efficiently.
Example services:
•Process Characterization Studies
•Virus Clearance Validation
•Scaled-down Model Validation
•Risk Assessments (Level 2A and 2B)
•Polymer Risk Assessments
•Microbial Contamination Control Strategies (Annex 1-compliant)
•Hold Time Studies – microbial and chemical, for buffers and intermediates
3.
Specialist (SME) support
Manufacturing operations constantly face a trade-off between resource availability and workload. Unforeseen deviations can create high-pressure situations. Koncis helps smooth out these peaks without the need for long-term overstaffing, particularly within downstream processing.
SME support includes:
•Root Cause Investigations of Deviations
•Impact Assessments
•CAPA Implementation
•Technical Training for Manufacturing Staff
4.
Inspection readiness
With extensive experience supporting successful inspections by both clients and regulatory agencies, Koncis offers tailored guidance to ensure your team is prepared. While there’s no universal method, there are common pitfalls that can be proactively avoided.
Services include:
•Inspection Readiness Assessments
•Structuring Inspection Response Teams
•Technical Presentation Development
•Staff Training on Inspection Communication
5.
CDMO selection and oversight
Selecting the right partner for outsourced development and manufacturing is one of the most critical activities in any biopharmaceutical project. Koncis supports you throughout the entire lifecycle — from early-stage partner screening to oversight during commercial production.
CDMO support services include:
•Initial facility-fit assessments
•Authoring of Requests for Proposal (RFPs)
•Evaluation of CDMO proposals and partner selection
•Review of master batch records and other critical GMP documentation
•Assessment of executed batch records
•Support during process development and characterization
•Oversight of Continued Process Verification (CPV)
6.
Process development and optimization
Downstream purification is often the bottleneck in biopharmaceutical production. Koncis brings experience from over 30 successful downstream process development and optimization projects.
Highlights:
•Deep expertise in monoclonal antibody downstream processing
•Experience with optimization of complex molecule processes
•Implementation of capacity expansion projects resulting in 100% increase in throughput
•Process improvements delivering >100% yield increases
Collaborating
with Sponsors and CDMOs
At Koncis, we bridge the gap between sponsors and Contract Development and Manufacturing Organizations (CDMOs), ensuring that both parties achieve their goals through aligned strategies, clear communication, and effective execution.
We support biopharmaceutical companies and biotech innovators in navigating the complex process of selecting and managing CDMO partnerships. Our services include:
- CDMO Selection and RFP Management: Crafting detailed Requests for Proposals (RFPs), evaluating bids, and selecting the optimal partner for your specific needs.
- Program Oversight and Troubleshooting: Acting as an extension of your team to manage CDMO interactions, resolve technical challenges, and maintain progress on critical project milestones.
- Technical assistance to Regulatory and Quality Assurance: Ensuring your product is manufactured in compliance with regulatory requirements, with robust documentation and readiness for inspections.
We also collaborate directly with CDMOs to enhance their operational efficiency and technical offerings, making them more attractive to sponsors. Our expertise includes:
- Technical Guidance and Strategy: Advising on biologics-specific challenges, such as optimizing microbial contamination control strategies or structuring robust virus clearance studies.
- Industry Insights: Providing CDMOs with a sponsor’s perspective to help them anticipate and meet client needs effectively.
- Audit and Inspection Support: Assisting CDMOs in achieving regulatory excellence and preparing for client or agency audits.
By working with both sponsors and CDMOs, we bring a unique perspective that fosters collaboration, builds trust, and drives mutual success. Our ability to “speak the language” of both parties ensures alignment and efficient resolution of challenges.
Technical excellence
and strategic mindset
At Koncis, we combine technical excellence with a strategic mindset to deliver solutions that not only address immediate challenges but also position our clients for sustainable growth. By leveraging a vast network of industry experts and fostering trust-based partnerships, we ensure that every project benefits from both deep expertise and practical execution.
We are here to support you in overcoming challenges and achieving your goals in the biopharmaceutical industry.