Progresspme Press Releases

Progress-PME and HollandBio host CMC seminar


Progress-PME and HollandBio host CMC seminar


Progress PME 200 x 32

Press Release | Progress-PME

NOVEMBER 06, 2019

Hoofddorp, The Netherlands: – Progress Project Management & Engineering (Progress-PME), the independent consultancy and management company specializing in the pharmaceutical, biotech and healthcare industries, has joined forces with HollandBio to host a workshop on Chemistry, Manufacturing & Control (CMC) projects.

The seminar in Utrecht on November 21 afternoon will detail issues of product quality, safety and efficacy that are key to compliance with Module 3 of the common technical document (CTD) regulatory submissions format that contain all the required quality information and data corresponding to the registration of a pharmaceutical product.

CTD guidelines

This involves examining product and processes, identifying critical product quality attributes and critical process parameters and improving process consistency.

These and other aspects will be examined by three speakers; Kees Groen from startup ORCA Therapeutics, a privately-funded biopharmaceutical company designing and developing new oncolytic immunotherapies for treatment of cancer, Pieter-Jan Vos of CDMO Batavia Biosciences and Karin Hoogendoorn, specialist in advanced therapy medicinal products (ATMPs) for human use based on genes, tissues or cells.

Partnership with HollandBio

Progress-PME is organizing the event in collaboration with HollandBio, the society that connects, supports and represents hundreds of life sciences companies and organizations in the Netherlands highly developed biotech community.

Places at the seminar are still available with registration available online (see Resources).

About Progress-PME

Progress-PME is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. It operates internationally, supplying project management, engineering, CMC, validation Lean/OPex and quality assurance services.

Progress-PME’s mission is to excel in supporting clients to realize their business goals, harnessing broad knowledge and experience, combined with focus and flexibility to guarantee high value services and projects and multi-disciplinary progress. Progress-PME offers general services in eight fields: project management, a specialized Quick scan & GAP analysis services helping companies into new markets or products, training, hospital pharmacy support, biobanking, and environmental management.

The company also offers management services covering fields such as Quality Management, Lean Six Sigma performance improvement, Chemistry Manufacturing and Control (CMC) for new pharmaceutical products, engineering and facilities support.

Founded in 1999, Progress-PME and its Executive Services subsidiary Progress EXS are privately-owned companies.

Further information at: https://www.progress-pme.com/home.html

About HollandBio

HollandBIO, the Netherlands’ biotech industry association, is one of the main anchors of the Dutch biotech sector and brings together more than 180 Dutch companies and organizations that are active in biotechnology. Its members represent all levels of the sector, including large corporations, small and medium-sized enterprises and start-ups, creating novel (bio)technologies, applications and products for agricultural, industrial, environmental, food or health use.

HollandBIO actively looks after the sector’s interests and support a strong, national and international network.

HollandBIO’s activities include advocacy, networking, national and international representation, as well as a number of services dedicated to supporting start-ups and SMEs.

Further information at: https://www.hollandbio.nl/

About Progress-PME / HollandBio CMC event 2019

Headlined “Time to market: When clinical trial time can be decreased, what is the new time critical factor?” the Chemistry, Manufacturing & Control (CMC) seminar is organized by Progress-PME and HollandBio.

This one-day event will be held on Thursday, November 21, 2019, between 1430 and 1700 hours, followd by a reception, at the Centraal Museum, Agnietenstraat1, in Utrecht.

Further information at: https://www.hollandbio.nl/event/time-to-market/

Media Contact

Edwin van den Bos, Chief Commercial Officer, Progress-PME
Tel: +31 6 5046 2179
Email: e.van.den.bos@progress-pme.nl

Resources

Click on Progress PME and HollandBio host CMC seminar for other information.
Click on Progress-PME to contact the company directly.
Click on Registration to book places at the CMC event.
Click on CMC services for more on Progress-PME’s chemistry, manufacturing and controls offerings.

CMC Seminar will feature three key speakers

CMC Seminar will feature three key speakers


Supplier Information
Supplier: Progress-PME
Address: Bijlmermeerstraat 20, 2131 HG Hoofddorp, The Netherlands
Tel: +31 235 63 5016
Website: www.progress-pme.com


Progress-PME Qualification team helps bringing leading-edge veterinary pharma aseptic facility online


Progress-PME Qualification team helps bringing leading-edge veterinary pharma aseptic facility online


Progress PME 200 x 32

Press Release | Progress-PME

OCTOBER 15, 2019

Hoofddorp, The Netherlands: – Progress Project Management & Engineering (Progress-PME), the independent consultancy and management company specializing in leading edge solutions for the pharmaceutical, biotech and healthcare industries, helps deliver a new 8000m2 manufacturing facility for a veterinary pharmaceutical manufacturer.

The new facility will double the aseptic manufacturing capacity for Netherlands-based veterinary pharmaceutical company Produlab Pharma and includes a 4-fold batch size increase.

Leading-edge separation

The expansion of the currently operational manufacturing facility with the new facility is particularly advanced in allowing β-lactam antibiotics, such as penicillin, to be separated from non-pen products.

Progress -PME is tasked with supporting the design and construction team and managing and executing the Commissioning & Qualification (C&Q) for the entire facility. This gave the PME team, supported by C&Q members of several other suppliers, responsibility for overall C&Q project management, including development of the strategy plan, protocols, planning, resources and deliverables.

Built-in quality

The C&Q activities are on schedule, with validated high quality and with no unpleasant surprises for the client, who commented:

“Progress-PME has shown itself to be a professional engineering and project management agency. The intrinsic knowledge of the C&Q Project Manager and the C&Q Engineers ensured we could concentrate on our core business.”

Progress-PME Chief Commercial Officer Edwin van den Bos said:

“We are very proud on the fact that the C&Q project is on schedule and progressing according plan. We have managed to relieve the customer in the decision-making process while delivering with high quality.”

About Progress-PME

Progress-PME is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. It operates internationally, supplying project management, engineering, CMC, validation Lean/OPex and quality assurance services.

Progress-PME’s mission is to excel in supporting clients to realize their business goals, harnessing broad knowledge and experience, combined with focus and flexibility to guarantee high value services and projects and multi-disciplinary progress. Progress-PME offers general services in eight fields: project management, a specialized Quick scan & GAP analysis services helping companies into new markets or products, training, hospital pharmacy support, biobanking, and environmental management.

The company also offers management services covering fields such as Quality Management, Lean Six Sigma performance improvement, Chemistry Manufacturing and Control (CMC) for new pharmaceutical products, engineering and facilities support.

Founded in 1999, Progress-PME and its Executive Services subsidiary Progress EXS are privately-owned companies.

Further information at: https://www.progress-pme.com/home.html

About Produlab Pharma

Produlab Pharma specializes in production of liquid and semi-solid veterinary pharmaceuticals for renowned pharmaceutical companies in more than 90 countries worldwide, and across the whole EU.

The company was founded in 1991 and is based at Raamsdonksveer near Breda in North Brabant, Netherlands.

Continuous expansion over 25 years has produced a company with facilities totaling more than 20,000 square meters and a -130 strong workforce, working with more than 400 recipes to produce some 3.000 different products in batches from one liter to 600 liters.

Daily production usually exceeds 2,500 liters of liquid and semi-solid veterinary pharmaceuticals.

Media Contact

Edwin van den Bos, Chief Commercial Officer, Progress-PME
Tel: +31 6 5046 2179
Email: e.van.den.bos@progress-pme.nl

Resources

Click on Progress-PME helps commission and qualification of advance production facility for other information.
Click on Progress-PME to contact the company directly.

Progress PME


Supplier Information
Supplier: Progress-PME
Address: Bijlmermeerstraat 20, 2131 HG Hoofddorp, The Netherlands
Tel: +31 235 63 5016
Website: www.progress-pme.com


Progress-PME is co-organizer of VCCN National Cleanroom Day


Progress-PME is co-organizer of VCCN National Cleanroom Day


Progress PME 200 x 32

Press Release | Progress-PME

OCTOBER 01, 2019

Hoofddorp, The Netherlands: – Progress Project Management & Engineering (Progress-PME), the independent consultancy and management company specializing in the pharmaceutical, biotech and healthcare industries, will be a prominent presence at the Dutch Association of Contamination Control (VCCN) National Cleanroom Day contamination control symposium in October.

Progress-PME, with its extensive expertise in cleaning validation regimes and compliance, is both a participant and part of the organizing committee of the one-day conference at the Spant! theatre in Bussum, southeast of Amsterdam.

Contamination control guidelines

The event, dedicated to contamination control guidelines in healthcare, provides a platform for organisations to share knowledge and expertise as well as a cleanroom and air-conditioning solutions.

The Progress-PME team at the event will be led by Director of Operations, Mark Vollebregt-Monajati, and will include consultant Martijn Monster, who has extensive practical experience as an engineer in the pharmaceutical industry with specific knowledge of GMP guidelines, commissioning and cleaning validation requirements.

Cleaning validation solutions

“We are looking forward to this meeting as a valuable contribution to increasing industry expertise in cleaning validation solutions as well as an opportunity for networking and picking up relevant information,” commented Mark Vollebregt-Monajati.

“Many of our clients and prospective partners in the life sciences and healthcare industries will appreciate that we support VCCN and are part of the team to organize such events with a goal of connecting different cleanroom suppliers and users and sharing the knowledge needed for more effective cleaning and sterilization solutions, both in equipment commissioning and day-to-day regimes,” he added.

About Progress-PME

Progress-PME is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. It operates internationally, supplying project management, engineering, CMC, validation Lean/OPex and quality assurance services.

Progress-PME’s mission is to excel in supporting clients to realize their business goals, harnessing broad knowledge and experience, combined with focus and flexibility to guarantee high value services and projects and multi-disciplinary progress. Progress-PME offers general services in eight fields: project management, a specialized Quick scan & GAP analysis services helping companies into new markets or products, training, hospital pharmacy support, biobanking, and environmental management.

The company also offers management services covering fields such as Quality Management, Lean Six Sigma performance improvement, Chemistry Manufacturing and Control (CMC) for new pharmaceutical products, engineering and facilities support.

Founded in 1999, Progress-PME and its Executive Services subsidiary Progress EXS are privately-owned companies.

Further information at: https://www.progress-pme.com/home.html

About VCCN National Cleanroom Day

Established in 1988, the Association of Contamination Control Netherlands (VCCN) promotes knowledge sharing for professionals in the field of contamination control and associated support facilities. VCCN is a member of the International Confederation of Contamination Control Societies ( ICCCS ) and .represents the interests of companies, institutions and organizations concerned with contamination control.

VCCN provides courses on the design, use, cleaning and maintenance of cleanrooms and operating rooms.. Besides teaching courses VCCN organizes conferences with prominent guest speakers, field trips and specialized exhibitions, along with oriented theoretical-, laboratory- and field research, providing information through literature documentation and periodic publications such as Its VCCN Magazine, which is published quarterly.

The VCCN’s National Cleanroom Day, titled ‘Contamination Control in Healthcare: More healthcare or less healthcare?’ is intended to cover the landscape of guidelines for operating rooms, central sterilization departments (CSA) and isolation rooms. It is a one-day symposium to be held on October 9 at the Spant! (Timber!) theatre and event center at Bussum southeast of Amsterdam

The event is organized by VCCN with further information at: https://www.vccn.nl/english/

Media Contact

Mark Vollebregt-Monajati, Director Operations, Progress-PME
Tel: +31 6 5046 2179
Email: m.vollebregt-monajati@progress-pme.nl

Resources

Click on Progress PME at VCCN National Cleanroom Day for other information.
Click on Progress-PME to contact the company directly.
Click on CMC services for more on Progress-PME’s chemistry, manufacturing and controls offerings.

VCCN National Cleanroom Day venue: Spant! Theatre, Bussum

VCCN National Cleanroom Day venue: Spant! Theatre, Bussum

Progress-PME has developed a comprehensive methodology for Cleaning Validation implementation

Progress-PME has developed a comprehensive methodology for Cleaning Validation implementation


Supplier Information
Supplier: Progress-PME
Address: Bijlmermeerstraat 20, 2131 HG Hoofddorp, The Netherlands
Tel: +31 235 63 5016
Website: www.progress-pme.com


Progress-PME to share cleaning validation insights at VFM 2019


Progress-PME to share cleaning validation insights at VFM 2019


Progress PME 200 x 32

Press Release | Progress-PME

SEPTEMBER 25, 2019

Hoofddorp, The Netherlands: – Progress Project Management & Engineering (Progress-PME), the independent consultancy and management company specializing in the pharmaceutical, biotech and healthcare industries, has been invited to share its insights on cleaning validation at the upcoming Vereniging voor Farmaceutische Microbiologie (Dutch Association of Pharmaceutical Microbiology) meeting.

The meeting will take place at Breukelen, near Utrecht in The Netherlands on October 09.

Cleaning validation strategies

Chairman of the VFM, Erik Verhagen, has invited Progress-PME to present and address on ‘Cleaning Validation: What if it fails?’

The presentation will be delivered by senior Progress-PME cleaning validation specialist and consultant, Paul Tiemeijer, who will outline a range of strategies, tools and services in this key quality and regulatory area

“In particular, I will discuss the topic “clean and dirty hold times in relationship with challenges to meet the microbiological requirements” said Mr. Tiemeijer.

Progress-PME seminar

Progress-PME will also promote its own workshop on Cleaning Validation to be held 14 days later at its headquarters at Hoofddorp, southwest of Amsterdam. The seminar will explore how cleaning method development can kickstart the successful implementation of a validated cleaning process, and how to avoid failures in cleaning validation.

The one-day seminar is aimed at professionals involved directly or indirectly with Cleaning Validation, including managers, supervisors, process engineers, QA/QC, Operations, Validation and Engineering staff.

Progress-PME will also use VFM as a valuable networking opportunity, hosting a reception after the conference sessions.

About Progress-PME

Progress-PME is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. It operates internationally, supplying project management, engineering, CMC, validation Lean/OPex and quality assurance services.

Progress-PME’s mission is to excel in supporting clients to realize their business goals, harnessing broad knowledge and experience, combined with focus and flexibility to guarantee high value services and projects and multi-disciplinary progress. Progress-PME offers general services in eight fields: project management, a specialized Quick scan & GAP analysis services helping companies into new markets or products, training, hospital pharmacy support, biobanking, and environmental management.

The company also offers consultancy and management services covering fields such as Quality Management, Lean Six Sigma performance improvement, Chemistry Manufacturing and Control (CMC) for new pharmaceutical products, engineering and facilities support.

Founded in 1999, Progress-PME and its Executive Services subsidiary Progress EXS are privately-owned companies.

Further information at: https://www.progress-pme.com/home.html

About VFM 2019

The VFM ( Vereniging voor Farmaceutische Microbiologie / Pharmaceutical Microbiology Association) is a non-profit organisation dedicated to promoting the exchange of information and discussion of subjects related to pharmaceutical microbiology.

The Association hosts a series of meetings during the year.

Its annual meeting (VFM 2019) is a one-day event held on October 9, 2019, at the Van der Valk Hotel in Breukelen, near Utrecht.

Speakers will include Dr. Ruth Daniels (Senior Scientist and Microbiology Expert at Janssen, Pharmaceutical companies of Johnson and Johnson), Quirine Hartman (research associate and scientist with Genmab and Eurofins Scientific), Patrick Nieuwenhuizen (Sterility Assurance Lead at Sanofi Waterford) and Dr. Philippe Gadal (Independent Director at ERBA Diagnostics, Inc. and CEO of Chemunex, Inc..

The event is organized by VFM with further information at: http://www.vfmicro.nl

Media Contact

Edwin van den Bos, Chief Commercial Officer, Progress-PME
Tel: +31 6 5046 2179
Email: e.van.den.bos@progress-pme.nl

Resources

Click on Progress PME at VFM 2019 for other information.
Click on Progress-PME to contact the company directly.
Click on CMC services for more on Progress-PME’s chemistry, manufacturing and controls offerings.

VFM meeting will take place at Breukelen, Netherlands on October 9, 2019

VFM meeting will take place at Breukelen, Netherlands on October 9, 2019

Progress-PME has developed a comprehensive methodology for Cleaning Validation implementation

Progress-PME has developed a comprehensive methodology for Cleaning Validation implementation


Supplier Information
Supplier: Progress-PME
Address: Bijlmermeerstraat 20, 2131 HG Hoofddorp, The Netherlands
Tel: +31 235 63 5016
Website: www.progress-pme.com


Progress-PME celebrates 20th Anniversary


Progress-PME celebrates 20th Anniversary


Progress PME 200 x 32

Press Release | Progress-PME

JUNE 27, 2019

Hoofddorp, The Netherlands: – Progress Project Management & Engineering (Progress-PME), the independent consultancy and management company specializing in the pharmaceutical, biotech and healthcare industries, is celebrating the 20th Anniversary of its founding.

It was in May 1999 that Paul Linssen created Progress-PME as a project management and engineering bureau to meet the growing need for expert specialized consultancy in the pharmaceutical and biotech field.

Covering whole product life cycle

Since then, the company has grown to become a team of more than 45 people with core skills in project management and consultancy with knowledge and expertise extending across the whole product life cycle, including CMC, engineering & construction, qualification & validation, commercial manufacturing, QA/QC/QP and decommissioning & Lean Six Sigma.

Milestones along the way have included ISO 9001 certification in 2008, extension into total product lifecycle and the creation of a subsidiary, Progress-EXS, offering executive management services.

Recently the company passed the 100 client mark.

To the top, together

Paul Linssen, Chairman of the board, commented: “The best way to summarise our progress is to see how our Corporate Mission has evolved into supporting the life sciences industry in bringing innovative, effective, safe and affordable medicines to the market and to serve the entire range or our clients’ product life cycles by integrating our individual skills, expertise and knowledge,”

“Looking forward to the next 20 years, our vision is to excel in supporting our customers in achieving their goals, employing highly qualified, skilled and experienced professionals. Delivering high-quality and multidisciplinary advice. Our top priority is to continuously train, motivate, stimulate and challenge our employees.”, said Mr. Linssen.

“We want to thank all our clients for their trust in Progress-PME and our team. We enjoy helping you reach your goals and hope to continue our good working relationships with all of you,” he added.

“As we celebrate our 20th Birthday, Progress-PME is united under our motto: ‘To the top together’ and looking forward to the future,” Mr. Linssen concluded.

About Progress-PME

Progress-PME is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. It operates internationally, supplying project management, engineering, CMC, validation Lean/OPex and quality assurance services.

Progress-PME’s mission is to excel in supporting clients to realize their business goals, harnessing broad knowledge and experience, combined with focus and flexibility to guarantee high value services and projects and multi-disciplinary progress. Progress-PME offers general services in eight fields: project management, a specialized Quick scan & GAP analysis services helping companies into new markets or products, training, hospital pharmacy support, biobanking, and environmental management.

The company also offers management services covering fields such as Quality Management, Lean Six Sigma performance improvement, Chemistry Manufacturing and Control (CMC) for new pharmaceutical products, engineering and facilities support.

Founded in 1999, Progress-PME and its Executive Services subsidiary Progress EXS are privately-owned companies.

Further information at: https://www.progress-pme.com/home.html

Media Contact

Progress-PME BV
Tel: +31 235 635 016
Email: kantoor@progress-pme.nl

Resources

Click on Progress PME celebrates 20th Anniversary for other information.
Click on Progress-PME to contact the company directly.

Progress PME


Supplier Information
Supplier: Progress-PME
Address: Bijlmermeerstraat 20, 2131 HG Hoofddorp, The Netherlands
Tel: +31 235 63 5016
Website: www.progress-pme.com


Progress-PME highlights CMC expertise at HollandBIO 2019


Progress-PME highlights CMC expertise at HollandBIO 2019


Progress PME 200 x 32

Press Release | Progress-PME

JUNE 14, 2019

Hoofddorp, The Netherlands: – Progress Project Management & Engineering (Progress-PME), the independent consultancy and management company specializing in the pharmaceutical, biotech and healthcare industries, will be a prominent presence at this June’s Dutch Biotech Event, HollandBIO 2019, at Maarssen, near Utrecht in The Netherlands.

A joined Progress-PME and Progress-EXS team consisting of Chief Commercial Officer Edwin van den Bos Alwin Voetman, Sales Director of its high-level strategic consultancy arm Progress EXS and Thijs Veerman, COO of Progress-EXS, will use the conference and networking event to present the company’s broad range of operational and strategic management services.

CMC service offerings

Progress-PME, currently celebrating its 20th Anniversary, will share insights on its expert services for biotech companies that include project management, chemistry, manufacturing and controls (CMC) development, CMC regulatory support, QA/QC/QP services, Engineering and Lean Six Sigma performance improvement

“CMC is a key area for biotech and at the heart of many of the aspects that will be discussed at HollandBIO,” noted Edwin van den Bos.

To the top, together

The company will also be talking about its expertise in quality management and regulatory advise for biotech products and ATMPs Progress-PME consultants are currently supporting prominent client Kite Pharma EU, within its QA and QC departments with setting up and further improving its quality systems. Kite, a Gilead company, has been at the forefront of cancer immunotherapy and is currently a leader in engineered T cell therapy.

“With core expertise in these and so many other fields crucial to biotech innovation and success , we expect to have many interesting and valuable conversations in Maarssen,” said Mr. Van den Bos.

“We will be reaching out to the many biotech players of all shapes and sizes gathered there to explore ways in which we can follow our corporate strapline, ’To the top, together’ he added.

About Progress-PME

Progress-PME is an independent consultancy company with customers in the pharmaceutical and biotechnology industries and in the healthcare sector. It operates internationally, supplying project management, engineering, CMC, validation Lean/OPex and quality assurance services.

Progress-PME’s mission is to excel in supporting clients to realize their business goals, harnessing broad knowledge and experience, combined with focus and flexibility to guarantee high value services and projects and multi-disciplinary progress. Progress-PME offers general services in eight fields: project management, a specialized Quick scan & GAP analysis services helping companies into new markets or products, training, hospital pharmacy support, biobanking, and environmental management.

The company also offers management services covering fields such as Quality Management, Lean Six Sigma performance improvement, Chemistry Manufacturing and Control (CMC) for new pharmaceutical products, engineering and facilities support.

Founded in 1999, Progress-PME and its Executive Services subsidiary Progress EXS are privately-owned companies.

Further information at: https://www.progress-pme.com/home.html

About HollandBIO 2019

The annual Dutch Biotech Event (HollandBIO) is a conference that welcomes biotech companies of all shapes and sizes, from start-ups to established multinationals, with a focus on emerging trends and innovative technologies.

The event offers keynote addresses from leading biotech entrepreneurs, hands-on technology workshops and networking with industry leaders and experts.

HollandBIO 2019 is a one-day event held June 28 at the InnStyle hotel in Maarssen.

The 2019 conference will feature keynote presentations from Kite Pharma founder, Dr. Arie Belldegrun, Executive Chairman and Co-Founder of Allogene and Chairman of Two River Group, UroGen Pharma and Kronos Bio, as well as from Dr. John Haurum, former CEO of F-Star Biotechnology and currently Chairman of Belgium’s AgomAb Therapeutics, whose CEO, Tim Knotnerus, will also address the conference.

The event is organized by HollandBIO with further information at: https://www.hollandbio.nl/event/dutch-biotech-event-2/

Media Contact

Edwin van den Bos, Chief Commercial Officer, Progress-PME
Tel: +31 6 50462179
Email: e.van.den.bos@progress-pme.nl

Resources

Click on Progress PME at HollandBIO 2019 for other information.
Click on Progress-PME to contact the company directly.
Click on CMC services for more on Progress-PME’s chemistry, manufacturing and controls offerings.

HollandBio Event 2019

Conference venue: InnStyle, Maarssen, The Netherlands

Conference venue: InnStyle, Maarssen, The Netherlands

Progress-PME is celebrating its 20th Anniversary

Progress-PME is celebrating its 20th Anniversary


Supplier Information
Supplier: Progress-PME
Address: Bijlmermeerstraat 20, 2131 HG Hoofddorp, The Netherlands
Tel: +31 235 63 5016
Website: www.progress-pme.com