Global Biomanufacturing Trends, Capacity, and Technology Drivers: Industry Biomanufacturing Capacity Overview

全球生物药制造的趋势、产能及技术驱动因素：行业产能概述

Posted: June 30, 2017

发布时间：2017年6月30日

Patti Seymour

Dawn M. Ecker

BioProcess Technology Consultants

原文链接：https://www.americanpharmaceuticalreview.com/Featured-Articles/188840-Global-Biomanufacturing-Trends-Capacity-and-Technology-Drivers-Industry-Biomanufacturing-Capacity-Overview/

Abstract

摘要

Biologic-based drugs are an increasingly important part of the product growth strategies for pharmaceutical and biopharmaceutical companies. As the number of commercial products and pipeline candidates grows, a crucial issue facing the industry is the current and future state of biomanufacturing capacity, the availability of that capacity, and the technologies impacting upstream and downstream bioprocessing. Pharmaceutical and biopharmaceutical companies and contract manufacturing organizations (CMOs) are aligning their strategies to not only address capacity but to address greater complexity in supplier risk and the adoption of advanced biomanufacturing technologies.

以生物技术为基础的药品是传统制药和生物制药公司成长战略中越来越重要的部分。随着商业化的产品和研发管线中候选者的数量增长，该行业面临的一个关键问题是生物药的制造能力（产能）在当前和未来的状态、产能的可用性，以及技术变化对生物药上下游的加工处理的冲击。传统制药公司、生物制药公司以及合同制造组织（CMO）正在调整其战略，不仅要解决产能问题，还要解决供应链高度复杂性的问题，并且采用先进的生物制造技术。

Biopharmaceutical products have rapidly become a larger percentage of overall pharmaceutical company revenue with sales of the top six selling antibody products, Humira, Remicade, Enbrel, Rituxan, Avastin, Herceptin, at just over $51B in 2015. The compound annual revenue growth rate for antibody products, which includes antibody conjugates, naked antibodies, and antibody fusion proteins, from 2003 to 2014 was 21%; however, this growth is expected to slow to the high teens in the coming years due to the maturation of many products, and emerging alternative technologies. Also, it is more difficult to sustain such growth rates the larger the market becomes.

生物药产品占整个制药公司收入的比例正在迅速增加，2015年销售前六大销售抗体产品Humira（阿达木单抗）、Remicade（英夫利昔单抗）、Enbrel（依那西普）、Rituxan（利妥昔单抗）、Avastin（贝伐珠单抗）和Herceptin（曲妥珠单抗）的销售额均高于51亿美元。抗体产品的复合年度收入增长率（包括抗体偶联物、裸抗体和抗体融合蛋白）在2003年至2014年间为21％；然而，由于许多产品逐渐变得成熟，以及新兴替代技术的发展，预计未来几年增长率将放缓至略低于20%。此外，市场规模变得越大，维持这种增长率就越困难。

To provide context about this growing segment of the market, BPTC estimates that there are over 900 biopharmaceutical products in some stage of clinical development in the United States or Europe, and the large majority of these products, 77%, are produced in mammalian cell culture systems. To further refine the biopharmaceutical manufacturing market, we evaluated the distribution of mammalian products by product type and phase of development. Figure 1 shows the distribution of the following product types, antibody products (which include naked monoclonal antibodies, Fc-fusion proteins, antibody fragments, bispecific, antibody conjugates, and other antibody-related products), blood proteins, cytokines, enzymes, fusion proteins, hormones and other recombinant proteins, by phase of development. Antibody products are the dominant product type for all phases of development, but this product type is even more dominant for early phase products. Antibody products comprise nearly half, 48%, of currently marketed products. Recall that many of the early commercial biopharmaceutical products, such as growth hormones, insulins and interferons, are produced in microbial systems, but the use of microbial production systems is much less common now. The percentage of antibody products currently in the BLA, or equivalent, stage of regulatory submission is 67% (BLA/MAA stage in Figure 1). Antibody products make up 82% of products in Phase 3 development and 90% of products in Phase 1 and 2 development.

BPTC推算了这一不断增长的细分市场的状态：在美国或欧洲有超过900种生物药产品处于临床的不同阶段，其中绝大部分产品（77％）是在哺乳动物细胞培养系统中生产的。为了进一步描述生物药制造市场的状态，我们根据产品类型和发展阶段评估了这些产品的分布。图1显示如下产品类型在不同研发阶段的分布：抗体产品（包括裸单克隆抗体、Fc融合蛋白抗体片段、双特异抗体、抗体结合物和其他抗体相关产品）、血液蛋白、细胞因子、酶、融合蛋白、激素和其他重组蛋白。在所有的研发阶段，抗体产品都占据主导地位，且它在早期研发阶段中的主导地位更为显著。抗体产品占目前市售产品的近一半，48％。回想一下，许多早期的商业生物制药产品，如生长激素、胰岛素和干扰素，都是在微生物系统中生产的，但现在，使用微生物系统却要少得多。目前在BLA（生物制品许可申请）及等价的申报阶段中，抗体产品所占百分比是67%（图1中BLA/MAA阶段）。抗体产品在III期临床中占82％，在I期和II期临床中占90％。

Figure 1. Distribution of Mammalian Products by Product Type and Phase of Developmen

图1. 哺乳动物细胞培养系统的产品类型和研发阶段的分布

Whether approved or in development, all of these products need access to mammalian production capacity. To better understand the production requirements needed to meet the demand for all of these products, we created a demand forecast. The future demand for current commercially approved biopharmaceutical products is estimated from each product’s reported annual sales data, along with estimates of each product’s future growth rates. A product’s growth in sales is calculated from actual sales data for the current and previous year. Where available, analysts’ forecasts may also be used to estimate year-to-year sales growth for commercial products. Our calculated future product growth estimations also take into consideration a product’s age; sales growth typically slows as a product matures, while newly approved products often do not reach full market penetration for several years.

无论已获批上市还是仍处于研发阶段，所有这些产品都需要哺乳动物细胞培养系统的产能。为了更好地理解满足所有这些产品需求而需要的产能，我们对需求进行了预测。对于已经获批上市、处于商业化阶段的生物制品，我们根据每种产品的年度销售数据以及未来的预期增长率来估算。产品的销售增长率是根据当前和上一年的实际销售数据计算得出的。在可能的情况下，分析师的预测也可用于估算商业产品的年度销售增长。我们估算未来的增长时也考虑了产品的年龄；随着产品的成熟，销售增长通常会放缓，而新上市品种往往需要数年时间才可达到充分的市场渗透。

Using the sales growth data along with the number of patients treated in the current year (based on price per mg and sales), an estimated treatment population for future years can be calculated for each year during the forecast period. This forecasted treatment population, combined with the yearly per patient dosing calculates the kilogram quantities of each product that will be required in future years. These forecasted product quantities along with an estimated expression level and overall yield estimates for each product can then be used to calculate the estimated amount of cell culture capacity (L/yr) that will be required for each product in future years.

使用销售增长的数据以及当年治疗的患者数量（基于每毫克药物的单价和销售额），可以估算在预测区间的每年治疗人数。根据预测的治疗人数，以及每位患者的每年剂量，可以计算出未来几年所需的每种产品的千克数。然后可以使用计算出的每种产品的千克数、每种产品的估计表达水平以及总体回收率来计算未来几年中每种产品所需的估计的细胞培养容量（升/年，L/yr）。

Figure 2 shows the forecasted kilogram quantities of product needed to meet annual commercial demand for all products types produced using mammalian production systems. In 2014, approximately 13 metric tons of product are needed, and the large majority of the demand is for currently commercial products (teal band). The orange band labeled Clinical on each bar represents an estimate of clinical trial material manufactured to support the clinical development of all pipeline product candidates in a given year. The green band, present but not visible in the 2016 bar, represents products that have submitted a BLA, or equivalent, and are estimated to receive regulatory approval and enter the commercial market in 2016. The cycle time of 1 to 1.5 years from submission of BLA to approval is based on industry standard product development success rates. Similarly, the grey band first appearing in the 2017 bar represents products in Phase 3 clinical development in 2014 that are projected to receive regulatory approval and begin entering the commercial market in 2017. This grey band increases each year as the commercial demand for the products grows. The purple band and the light blue band represent the products in Phase 2 and Phase 1 development, respectively, that are forecasted to begin entering the commercial market in 2018 and 2019, respectively. As more products receive commercial approval each year, the overall kilogram requirements needed to meet commercial product demand increase from just over 13 metric tons in 2014 to nearly 40 metric tons in 2020.

图2显示了使用哺乳动物细胞系统生产可供满足所有产品类型所需的预测千克数。2014年需要约13吨的产品，大部分需求来自目前的商业产品（蓝绿色）。橙色表示“临床”，这是为支持特定年份所有的临床项目开发而制造的临床试验材料的估计。绿色表示已提交BLA（生物制品许可申请）或等价的申请、预计将于2016年获得监管部门的批准并进入市场的产品，它在2016年的柱子中存在但未显示出来。自提交BLA申请到获得批准的耗时约1至1.5年，这是符合行业标准的产品开发周期。同样的，最初出现在2017年柱子中的灰色代表着2014年处于III期临床阶段的产品，预计将于2017年获得监管部门批准并开始进入商业市场。随着产品的商业需求增长，这一灰色带的长度逐年增加。紫色和浅蓝色分别代表II期和I期临床开发中的产品，预计分别在2018年和2019年开始进入商业市场。随着未来每年越来越多的产品获得商业批准，满足商业产品所需的总重量从2014年的13吨多增加到2020年的近40吨。

Figure 2. Forecast of Bulk Kilograms Needed to Meet Product Demand

图2. 满足需求的千克数的预测

Another way to view the total production capacity needed to meet product demand between 2014 and 2020 is to think of the demand in terms of total installed volume of mammalian cell culture capacity. Figure 3 shows the volumetric capacity required to support the clinical development and eventual commercial sales of all current pipeline product candidates in the year shown. An estimation of yield is required to go from kilogram demand to liter demand and introduces some uncertainty in the forecast due to the fact that most companies do not publish their production yields. For this reason, our analysis uses industry average estimates. As described for annual kilogram demand in Figure 2, each bar represents the volume required for those products in the indicated phase of development in 2014 that successfully reach the commercial market. In 2014, the annual volumetric requirements were just over 1,600 KL, while in 2020, the volumetric requirements will be just over 3,400 KL.

评估2014年至2020年间满足所有产品所需的总产能的另一种方法是考虑哺乳动物细胞培养在容积上的需求。图3显示了支持当前研发管线中所有候选品种的临床开发和最终商业生产所需的容积。由于大多数公司没有公布其生产效率，因此需要通过已知对千克数的需求（对重量的需求）去估算对升的需求（对容积的需求），这会在预测中引入一些不确定性。因此，我们的分析使用了行业平均估算值。如图2中对年度千克数的需求，不同颜色的条表示2014年时所处的开发阶段、并在未来成功进入商业市场的产品所需的容积。2014年，年度容积需求刚刚超过160万升，而到2020年，容积需求将超过340万升。

Figure 3. Forecast of Volumetric Capacity Needed to Meet Product Demand

图3. 满足需求的容积的预测

Given this increase in volumetric demand over the next 5 years, the industry is concerned about the availability of production capacity. There is always some degree of uncertainty in balancing the demand and supply equation due to production problems, market demand over time and competitive factors. As shown in Figure 4, in 2016, the available mammalian cell culture supply is currently approximately 3,600 KL and is projected to grow to approximately 5,600 KL by 2021. However, not all capacity is equally available throughout the industry. In 2016, Product companies (companies focused on product development) hold approximately 73% of the installed mammalian cell culture capacity, while Excess companies (companies that are developing products, but also sell or make available any excess manufacturing capacity) and CMOs control significantly less capacity, 13% and 14%, respectively. The forecasted distribution of capacity changes only slightly in 2021, with Product companies holding 68% of the installed capacity, while CMO companies increase to 15% and Excess companies increase to 17% of the capacity.

鉴于未来5年对产能的需求增加，该行业对产能是否足够感到担忧。供需平衡总会存在一些不确定性，其原因包括生产中的技术问题、随时间推移的市场需求变化以及市场竞争因素。如图4所示，2016年，现有产能可以生产的供应量约为360万升，预计到2021年将增长至约560万升。然而，并非整个行业都可以使用这些产能。2016年，产品公司（专注于产品开发或制造的公司）拥有大约73％的产能，而产能过剩公司（正在开发或制造产品，但也出售或出租过剩产能的公司）和CMO控制的产能则明显较低，分别为13％和14％。预计到2021年，产能的分布将有轻微变化，产品公司拥有68％的产能，而CMO公司将增加到15％，产能过剩公司则增加到17％。

Figure 4. Current Mammalian Manufacturing Capacity

图4. 哺乳动物细胞培养系统的产能

When comparing clinical versus commercial capacity, it is evident that the total volume of capacity devoted to commercial manufacturing far exceeds that devoted to clinical production. In 2016, nearly 390 KL (11%) of capacity are designated for clinical manufacturing compared to nearly 3,250 KL (89%) for commercial products. In 2021, percentages do not change, with approximately 600 KL of clinical capacity and just over 5,000 KL for commercial capacity. This is not surprising because of the relatively small demand for clinical supply in comparison to the larger demand for commercial sale.

比较用于临床试验与商业制造的产能，很明显，用于商业制造的产能远远超过用于临床试验的产能。2016年，将近39万升（11％）的产能被用于临床试验，而用于商业产品的则有近325万升（89％）。到2021年，该百分比没有变化，用于临床的产能约为60万升，而用于商业的产能则略超过500万升。这并不奇怪，因为与商业销售的较大需求相比，临床试验上的需求相对较小。

While Product companies control the majority of cell culture capacity, capacity is highly concentrated among ten companies. Table 1 shows the distribution of capacity among the top ten capacity holders in a given year. Capacity for companies not ranked in the top 10 are included in the “All Others” category. In 2016, the “All Others” category includes 120 companies, and in 2021 “All Others” include 128 companies. In 2016, 67% of the mammalian cell culture capacity is controlled by ten companies; in 2021, this changes to 61%. Based on substantial capacity investments, Samsung, Bristol-Myers Squibb and Novartis will displace Pfizer, Celltrion and Lilly from the top ten capacity holders by 2021.

商业产品公司控制着大部分细胞培养能力，产能则高度集中在前10家公司。表1显示了特定年份前十大产能拥有者的产能分布状态。未列入前10名的公司的产能包含在“其他所有”类别中。2016年“其他所有”类别包括120家公司，2021年“其他所有”则包括128家公司。2016年，67％的产能由前10家公司控制；到2021年则变为61％。通过在产能上投下巨资，三星、百时美施贵宝和诺华将在2021年取代辉瑞、Celltrion和礼来，进入产能前十（译注：Celltrion已宣布建设新的三期工程，将拥有36万升产能，预计在2019年后竣工）。

Table 1. Capacity Control

表1. 各公司对产能的控制

Geographic distribution of capacity may also skew the accessibility to capacity. Figure 5shows in 2016, North America holds the greatest percentage of capacity (52%), followed by Europe (32%) and Asia (16%). In 2021, the order remains the same but the percentages change slightly – North America (42%), Europe (34%) and Asia (24%). There has been significant growth of capacity in Asia, particularly in Korea and Singapore, due to government incentives and tax advantages. Asian locations for manufacturing also tend to be more attractive to companies with mature pipelines and the ability to manage complex global supply chains.

产能的地理分布也可能会影响其可及性。图5显示，2016年北美的产能占比最高（52％），其次是欧洲（32％）和亚洲（16％）。在2021年，各地区占比的排序保持不变，但百分比略有变化——北美（42％）、欧洲（34％）和亚洲（24％）。由于政府激励政策和税收优惠，在亚洲，特别是韩国和新加坡，产能将出现大幅增长。对于拥有成熟管线且具备管理复杂的全球供应链能力的公司而言，亚洲地区往往更具吸引力。

Figure 5. Geographic Distribution of Capacity

图5. 产能的地理分布

Irrespective of ownership or geographic location, there is a surplus of capacity as shown in the balance between a demand for mammalian cell culture and total available capacity in Figure 6. The light grey band in each bar represents the remaining available capacity. This analysis assumes an average capacity utilization of 18 batches per bioreactor per year. The demand for manufacturing capacity has been adjusted forward one year to account for the fact that bulk product is typically made well ahead of actual sales, on which demand calculations are based. For the majority of products sold in 2014, for example, bulk drug substance was manufactured in 2013.

无论产能的所有权或地理位置如何，总需求与总产能之间的对比显示，存在着过剩产能，如图6所示。柱状图中的浅灰色部分代表剩余的可用产能。该分析假设每个生物反应器每年平均可以使用18批次。对产能的需求已经向前调整了一年，因为生产原料要比实际销售早得多，而对产能的需求取决于原料的生产。例如，对于2014年销售的大部分产品，其原料实际上在2013年生产。

Figure 6. Overall Industry Supply and Demand Balance

图6. 总体产能和需求对比

Our analysis shows there is currently sufficient mammalian cell culture capacity world-wide to meet the total industry demand and that in 2014, only 50% of industry-wide cell culture capacity was utilized. This analysis of capacity utilization also indicates that while manufacturing capacity in general is projected to grow in the coming years, the demand for capacity will grow at a slightly greater rate so that by 2020 industry-wide capacity utilization will increase to 73%. At this anticipated level of utilization in 2020, some companies are likely to be challenged meeting the demand for specific products or gaining access to capacity at CMOs.

我们的分析表明，目前世界范围内有足够的产能来满足整个行业的需求，2014年，全行业只有50％的产能被利用。对产能利用率的分析也表明，虽然预计未来几年的产能总体保持增长，但对产能的需求将以更高的速度增长，因此到2020年，全行业的产能利用率将增加到73％。在2020年的预期利用水平下，一些公司可能在满足特定产品的生产需求上遇到一些挑战，或者在寻求CMO的外包生产上遇到一些麻烦。

A utilization rate of 50% may give the appearance that the industry is not currently operating at “full utilization”. However, manufacturers often consider “full utilization” in the range of 70-80% (or in some cases even lower) rather than 100% to account for change-overs, preventative maintenance, and facility upgrades. Product company manufacturers often take a proactive approach in protecting unused capacity to be able to respond to product demand surges and additional product indication approvals.

目前50％的利用率可能会让人产生该行业的产能没有被“充分利用”的感觉。但是，制造商通常认为“完全利用率”在70-80％（在某些特殊情况下甚至更低）的范围内，而不是100％，这是考虑到生产线更换为生产其他产品、预防性维护和设施升级的时间成本。商业产品的制造商通常积极维护尚未使用的产能，以便快速响应现有品种的需求激增，以及新品的获批。

As with any forecasting model, our assumptions are based on the mostly probable scenarios. However, if biopharmaceuticals being developed for certain large patient population indications such as Alzheimer’s disease or those targeting the PDL/PDL-1 checkpoint in cancer are approved and covered by Pharmacy Benefit Managers, a significant increase in demand for manufacturing capacity will occur potentially leading to a serious capacity shortage.

与任何预测模型一样，我们的假设基于最可能的情景。尽管如此，如果针对某些大型患者群体适应症的品种获得批准（如阿兹海默症），或者针对肿瘤中PD-1/ PD-L1检查点的生物药获得医疗保险的覆盖，则对产能的需求将大幅增加，有可能导致严重的产能短缺。

Conversely, there are other manufacturing trends that will result in a lesser demand for some biopharmaceuticals, such as the increased focus on orphan drugs and a shift from full length naked antibodies to alternative antibody formats and more potent products, i.e., Antibody Drug Conjugates (ADCs), which would require lower doses, that in turn, would reduce the demand for manufacturing capacity.

相反，目前也存在一些趋势，可能导致对某些生物药的需求减少，例如对孤儿药的关注度增加、从全长的裸抗体转变为替代形式的抗体、以及更有效的产品，如抗体药物偶联物（ADC），它降低了对剂量的需求，这样一来，它对产能的需求就下降了。

As the biopharmaceutical industry has grown, the industry has built a certain type of capacity to meet the demands for the top six selling antibody products. The 2014 kilogram demand for each of the top six selling antibody products was >0.75 metric tons for a total 8.5 metric tons. The demand for all other antibody products combined was approximately 4 metric tons. The forecasted demand for approximately 70% of new products approved between 2016 and 2020 is expected to be less than 100 kg per year per product with the exception of Alzheimer’s, PD-1/PDL-1, asthma, and possibly some PCSK-9 products. Future commercial manufacturing demands for 50% of products in Phase 2 and Phase 3 clinical development today can likely be met with a 5,000L bioreactor or smaller per product (See Table 2). This does not mean that large scale capacity is no longer needed. Our forecasts predict that the remaining 50% of products will need bioreactor capacity of 10,000L and greater to meet the predicted demand.

随着生物制药行业的发展，该行业已经建成了足以满足前六大抗体产品需求的产能。对于前六大抗体产品，其中任意一种在2014年的重量需求均大于0.75吨，合计需求达8.5吨。而对其他所有抗体产品的需求总和约为4吨。除了阿兹海默症、PD-1 / PD-L1、哮喘以及可能的一些PCSK-9产品之外，预计2016年至2020年期间批准的新产品中约70％的预测需求量低于每年100千克。对于目前处于II期和III期临床开发中的一半产品，未来上市后的商业生产上，很可能采用5,000L或更小的生物反应器即可满足需求（见表2）。但这并不意味着不再需要大规模产能。我们的预测显示，剩下一半产品将需要10,000L及更大的生物反应器才可满足预测的需求。

Table 2. Number of Product Demand Met by Bioreactor Scale
表2. 商业化的产品对不同容积的生物反应器的需求数量

Overall, the biopharmaceutical industry is expected to continue to have strong growth for the foreseeable future, and antibody products will be the dominant driver of this growth. Installed capacity is currently able to meet the manufacturing demand for these products, but control and location of capacity can affect how accessible certain capacity is. The majority of capacity is product based, as opposed to CMO based, making it difficult for companies without capacity to access it at the right time and under the right conditions. North America has the greatest percentage of installed capacity, but Asia has seen a surge in new capacity installation. To meet increased product demand, installed capacity is forecasted to increase from approximately 3.6 ML in 2016 to approximately 5.6 ML in 2021. While capacity will increase, demand for capacity will increase at an even faster rate potentially resulting in capacity shortages by 2021. We have noted that the industry is already experiencing some capacity constraints at the clinical scales due to very high clinical demand. The type and scale of capacity being installed will also be important as the demand for 50% of products in mid-to-late stage development can be met with 5,000L of capacity or less; while the other 50% of products will need larger, and potentially much larger, capacity to meet future demand. How the industry responds to these demands for capacity will certainly be critically important to ensure these products are available to the patients.

总体而言，生物制药行业在可预见的未来将继续保持强劲增长，抗体产品将成为增长的主要推动力。现有产能能够满足当前产品的生产需求，但产能的控制者和所在位置可能会影响部分产能的可及性。大多数产能用于生产商业化的产品，而CMO提供产能有限，这使得没有产能的公司很难在有需要的时候和合理的条件下使用这些产能。已有产能的占比中，北美最高，而来自亚洲的新产能激增。为满足不断增长的产品需求，产能预计将从2016年的约360万升增加至2021年的约50万升。在产能增加的同时，对产能的需求将以更快的速度增长，这可能导致在2021年出现产能短缺。我们已经注意到，由于临床试验的需求非常高，目前行业在满足临床需求上遇到了一些瓶颈。产能的类型和规格也很重要，因为对于中后期开发中的一半产品，其上市后的商业化生产可以由5,000L或更小容积的生物反应器去满足；而另外一半产品则需要更大、甚至巨大的生物反应器才可满足未来的需求。面对患者的迫切需要，行业以何种方式来响应这些对产能的需求是至关重要的。

References

参考资料

Ecker DM, Ransohoff TC, Jones SD, Levine HL. The state of mammalian cell culture biomanufacturing. Woburn (MA): BioProcess Technology Consultants, Inc.; 2011 Dec 12. 150 p. Available from: http://www.bptc.com/reports.php.Pavlou AK, Reichert JM. Recombinant protein therapeutics-success rates, market trends and values to 2010. Nat Biotechnol. 2004 Dec;22(12):1513-9.DiMasi JA, et al. Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther. 2010 Mar;87(3):272-7.

Author Biographies

作者简历

Patricia Seymour, M.B.A., CSCP, is a Senior Consultant with BioProcess Technology Consultants and has over 25 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development, quality, regulatory and manufacturing, supply chain strategy, and management and operations leadership. Ms. Seymour was formerly Sr. Director, Global Investigational Supply Operations at Millennium. She previously held positions at Covance, Collaborative BioAlliance, ImmunoGen, Dana Farber Cancer Institute and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University and is a Certified Supply Chain Professional (APICS).

Dawn M. Ecker, M.S., is a consultant with BioProcess Technology Consultants, and has 25 years of experience in the biotechnology industry. At BPTC she is responsible for maintaining the company’s bioTRAK® database for biopharmaceutical products, manufacturing capacity, and related topics, as well as for developing client-specific analyses based on this data. Ms. Ecker holds a B.S. in Microbiology/Biotechnology from Quinnipiac University and a M.S. in Biology from Worcester Polytechnic Institute.

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