Figure 1.
Integrating production processes within a complete facility does not always lead to a costly execution and long time to market for end users. This is what a specialist company such as Boccard can offer thanks to its expertise in process design and construction of pharmaceutical GMP systems, and thanks to a different project implementation strategy that focuses on the client’s core business, production needs, and operating methodologies.
Case Study: Alpha Biologics Facility Project in Malaysia
Present in 20 countries, with 3,000 employees worldwide and more than 30 years of excellent track record as a turnkey process system supplier, Boccard has become a major player in the pharmaceutical and biotechnology industry.
Alpha Biologics is an independent CMO offering FDA/EMEA CGMP compliant services to the worldwide pharmaceutical and biotechnology industry. Initial process development is undertaken by their experienced team in Cambridge, England, before being transferred to Malaysia for final process...
Baxter Bioscience’s Hayward CGMP manufacturing facility offers dedicated capacity backed by 15 years of experience in developing and manufacturing monoclonal antibodies and recombinant proteins. We offer the firepower you need at any stage of development. Our goal is simple: to advance your biologic at any step — from preclinical to commercial — in the most timely and cost-effective manner possible.
This state-of-the-art, licensed facility is located in the premier Biotech Bay for fast and flexible service. Just under 30 miles from San Francisco (in Hayward’s mixed industrialized area), this facility offers global regulatory expertise, intensive yield-improvement programs, mature quality systems, continuous improvement initiatives, and a proven track record for operational excellence.
The one-story facility has two main buildings with a combined area of 70,000 ft
2
. The plant is regularly inspected by the FDA and EMEA, and it is ISO 9001 and OHSAS 18001 certified. Bioreactors on the two CGMP manufacturin...
Figure 1.
Effectively working with a contract manufacturer’s project management team to ensure project success is a key goal for not only Althea Technologies, but for all companies working on difficult and complex manufacturing projects. Project management tools are widely used to effectively manage biotechnology and pharmaceutical product development. Implementing a project management office (PMO) is still a challenging undertaking for a contract manufacturing organization that has a wide array of project requirements to address. There are a number of models for effective PM strategy including ISO 9000 (
www.iso.org
), PMBOK (
www.pmi.org
) and Prince2 (
www.ogc.gov.uk
) among many others. Generally, the PMO becomes involved at the final stages of a deal close and oversees activities throughout the project life cycle (PLC) shown in Figure 1.
The PLC is a set of four generalized steps composed of activities from initiation through closure. Although the time required for the first and last steps is much le...
Avecia’s industry-leading expertise enables customers to improve the cost-effectiveness and profitability of new therapies, while maintaining fast-track progress into, and through, their clinical development programme.
Process Development and Scale Up
Avecia’s experience ensures that process development is applied appropriately dependent upon the development needs of customer products at different clinical stages.
cGMP Manufacturing
Four cGMP streams for the manufacture of microbially-derived biologics provide capacity from 100 L to 5,000 L:
Quality and Regulatory Support
Independent Quality Unit with representation on programme teams:
Programme Management
Avecia brings a distinctive management approach to programmes:
For more than 25 years, Invetech has been at the forefront of breakthrough product development and automation. Today we are as recognized for our unique approach as for the resulting commercial successes. Working with ambitious start-ups through to successful global businesses, our specialist expertise in design, engineering, and manufacturing enables us to deliver solutions that are as practical as they are marketable. Our award-winning portfolio has led advances across medical, industrial, and consumer markets, enabling clients to forge new ground and penetrate markets with commercial certainty.
With experience drawn from over 5,000 projects, we have developed the specialist capability needed to develop and manufacture custom automation systems, devices, instruments, and consumables. Our expertise covers a wide range of sectors including diagnostics, medical devices, life sciences, bioprocessing, and drug discovery. Invetech’s strength is our range of skills — from concept development through preparatio...
i3 is a global business providing integrated scientific strategies and solutions throughout the biopharmaceutical product lifecycle. Its combination of products, services, and knowledge helps companies gain sharper insights that lead to better patient care.
i3 Research
i3 Research is a full-service clinical research organization (CRO) focused in cardiology, central nervous system, endocrinology and metabolic disease, oncology, and respiratory and infectious disease. Therapeutic specialization drives all aspects of this group’s business — from project staffing and talent management to quality initiatives, such as six sigma. i3 Research has experience with trials of all sizes — from large multinationals to small niche studies.
i3 Innovus
i3 Innovus provides a scientific view of the marketplace — an expert perspective to help clients make smart decisions about their products. With leading expertise in health economics, outcomes, and late phase research, i3 Innovus delivers scientific evidence to support mark...
SAFC Biosciences views supply chain management as a structured process that seeks to evaluate, monitor and control supply chain risk, safeguarding continuity while maximizing profitability for its supply chain partners. Successful supply chain management in the biopharmaceutical industry is no longer simply a case of having the right material in the right place at the right time to guard against production delays. Today, the basis of our supply chain offering includes risk mitigation, robust supplier relationship management and critical raw material management, combined with a deep understanding of our customers’ unique and changing needs.
The traditional cost-focused supply chain has evolved into a center for value creation. Although there will always be a drive to increase shareholder value by reducing cost, we recognize the increasing importance of creating relationships with many specialized partners, drawing on their core competencies to improve overall customer service and facilitate entry into new ...
Figure 1.
Fed-batch versions of stirred-tank cell culture have become most popular at large scales. The primary driver of a mid-run addition of nutrients to batch cultures is to increase the quantity of product harvested. The prevalence of fed-batch over other modes is attributable to many practical factors such as reliability, scalability, and application latitude. Increases in the integral of viable cell concentration and volumetric productivity are commonly the greatest improvements obtained (
1
).
Factors determining optimum feeding of cultures include maintaining desired metabolism in high-density cultures, prolonging cell viability and preventing apoptosis, promoting longevity of cultures, promoting high-quality product accumulation, and encouraging product accumulation.
The six Thermo Scientific HyClone Cell Boost supplements each provide a unique selection of such particular nutrient categories as amino acids, vitamins, lipids, cholesterol, glucose, and/or growth factors in complements for multipl...
Figure 1.
With over 60 years experience in microbial protein expression, Novozymes offers a range of animal-free recombinant supplements — designed and manufactured exclusively for industrial cell culture — that allow developers to “rethink” their media strategy. These products provide proven performance benefits in a defined and regulatory-compliant manner, ensuring optimal media development for enhanced cell productivity.
Recombinant Human Albumin (rHA)
Novozymes has developed a range of rHas (Recombumin®, albucult™, and CellPrime™ ralbumin AF-S) suitable for industrial cell culture and biomedical applications, such as protein drug and vaccine formulation and medical device coatings. Microbially expressed Novozymes’ rHAs offer the benefits of albumin in a compliant, consistent way and represent a convenient replacement to animal and human-derived sources.
LONG®R
3
IGF-I
LONG®R
3
IGF-I is a recombinant analog of IGF-I and a highly potent alternative to recombinant insulin that is currently used in the ma...
Figure 1.
Albumin is used in cell culture media as a replacement for serum because of its positive effect on cell growth and productivity (
1
,
2
,
3
). Albumin is a known transporter of nutrients, lipids, and it removes toxins and waste products (
2
,
3
). Albumin is a classic performance-enhancing ingredient in many serum-free media formulations (
1
). However beneficial, plasma-derived albumin is undesirable because animal products present potential contamination by infectious agents. Cellastim™ recombinant human serum albumin is an animal-free albumin specifically developed for enhancing cell culture performance. Cellastim™ is manufactured using a plantderived expression system free of animal-derived components.
Cellastim™ rHSA vs. pHSA
The benefit of supplementing media with Cellastim™ rHSA was compared with plasma-derived HSA (pHSA) in three cell lines: hybridoma, CHO, and vero. Cellastim™ was evaluated in a variety of serum-free formulations including serum-free, protein-free, and chemically define...
Figure 1.
Optimization of key factors in a biopharmaceutical process is necessary to meet the continuous rise in production demands. Choice of cell culture media and peptone supplementation is critical to process performance. However, medium development can be a multifaceted process requiring a large number of resources. To comprehensively cover all variables with the least time and effort, statistical methods are employed. Using statistical methods can help identify an animal free (AF) peptone that effectively enhances protein production for a particular process.
Peptone Selection Process
There are three basic questions to be answered when working with peptones: What is the best peptone for a process? What peptone concentration should be used? Should an individual peptone or a blend of peptones be used? Cell lines perform differently according to the base medium and peptone supplementation used, so it is critical to evaluate various media and peptones to identify the optimal medium and feed strategy. For...
