BioProcess Technology Consultants | Outsourcing and Supply Chain Management

OUTSOURCING AND SUPPLY CHAIN MANAGEMENT

“Make or Buy” Analysis
With successful product development, companies are faced with the often difficult decision of choosing between a large capital investment in manufacturing facilities and infrastructure or outsourcing. BioProcess Technology Consultants has helped many companies evaluate their unique situation and has provided guidance and recommendations to the difficult “make or buy” question. Our analyses and recommendations are based on a detailed review of technology, investment costs, available resources and options, and an understanding of our client’s risk profile. At BioProcess Technology Consultants, we:

Provide technology evaluations, including the composition and timing of our client’s product portfolio, to determine how these pipeline forecasts will translate into capacity, capabilities and/or facility requirements.
Develop risk mitigation or avoidance plans that take into account the potential risks associated with both sides of the “make or buy” equation.
Provide valuation analysis and related services, such as the construction of comprehensive cost and process models, for evaluating building, expanding and/or acquiring capacity.

Outsourcing and Supply Chain Management Services
We offer comprehensive CMC outsourcing services, including the identification, qualification, and management of appropriate service providers for such activities as cell line development and banking, process development, bulk manufacturing, analytical method development and qualification or validation, release testing, drug product manufacturing, and labeling, packaging, storage, and distribution of cell lines, intermediates, clinical supplies, or commercial product.

BioProcess Technology Consultants can assist clients in identifying and choosing contract service providers by developing a RFI / RFP (request for information/proposal), performing site visits and/or QA audits, and reviewing proposals and other contractor-supplied material to assess their technical and regulatory competence and compliance and suitability for a project. We can also assist with the negotiation of service contracts, tech transfer for project initiation and the ongoing management of outsourced activities.

Our seasoned professionals develop outsourcing strategies that meet the needs and requirements of our clients and their products from the earliest stages (e.g., prior to “first in person” clinical trials) through commercialization. We can support all nodes of the supply chain, including:

Raw material procurement and storage
Bulk drug substance manufacturing, storage, and shipping
In-process intermediate storage and handling
Final drug product manufacturing, storage, and shipping
Labeling and packaging of intermediates, bulk and final product
Shipment, handling, and testing of in-process samples
Finished goods storage and distribution

Our supply chain management services include:

Assistance with the development and implementation of strategies for logistics and cold chain management
Preparation or assessment of systems for inventory planning and management
Construction of models and plans for maintaining a balance between demand and supply (sales and operations planning)
Assistance with the implementation of ERP systems (enterprise resource planning [ex. SAP, Oracle]) and the preparation and implementation of business case justifications

GMP Facilities
BioProcess Technology Consultants has extensive experience in the design, construction, and validation of cGMP manufacturing facilities. We assist clients in all phases of a facility project, from preliminary technical and economic evaluations through design, construction (including equipment specification, purchase, and installation), start-up, qualification, and final validation. We have relationships with professional engineering firms to facilitate any construction project and can serve as either project manager or owner's representative to ensure that projects remain on schedule and on budget.

We are also uniquely positioned to assist companies in determining the best use, value, and potential market for GMP biomanufacturing facilities. Our proprietary manufacturing supply and demand databases coupled with our extensive experience in the design and operation of biopharmaceutical facilities allows us to provide realistic and objective assessments of these expensive and time-sensitive assets.

We have worked with multiple clients, ranging from start-up companies to market leaders to:

Review the technical suitability of biomanufacturing facilities
Determine regulatory compliance of biomanufacturing facilities and associated systems
Assess potential uses and market value of existing facilities and evaluate modifications necessary to address certain market areas
Market cGMP biopharmaceutical facilities to appropriate target audiences
Assist in transition planning and management during sale/occupant changeover of a facility
Provide conceptual design of facilities to meet business and market objectives
Model manufacturing costs and processes to aid decision making